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115 Metabolic Syndrome Trials
Power is an online platform that helps thousands of Metabolic Syndrome patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Safflower Oil + Soy Pretzels for Metabolic Syndrome
Columbus, OhioThis research study is being done to help researchers develop new dietary options for menopausal women to maintain a healthy weight by developing more nutritious snacks that have health benefits. From this study, the researchers hope to gain understanding on how menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its own and when combined with soy. The research team hypothesize that the two different types of pretzels may be processed by your body differently and that components in the pretzel snacks may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans contain many natural chemicals that may benefit human health. However, this relationship is not well understood. This study will look at the impact of the pretzel snacks on your blood fat and glucose levels as well as a group of chemicals found in soy called "isoflavones". Isoflavones are natural chemicals found commonly in soybeans or foods made from them.
Participants will be screened to determine if they qualify in meeting the study requirements. Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein. Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The study will require five visits to the Ohio State University Clinical Research Center (CRC) which part of the Ohio State University's Center for Clinical and Translational Sciences. Once the investigators have determined that you qualify for this study and you decide to participate, you will be consuming three different pretzels each for one month, starting with a control pretzel. After the control pretzel treatment period, you will be randomly assigned (like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel with safflower oil) for your first treatment period and then switch to the other safflower oil pretzel at your second treatment period.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45 - 70
Sex:Female
20 Participants Needed
Ketogenic Diet for Rheumatoid Arthritis
Columbus, OhioThis is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 65
Sex:All
6 Participants Needed
MOMI PODS for Postpartum Health
Columbus, OhioThe investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:All
Sex:Female
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Major Infant Complications, Others
384 Participants Needed
Ketone Supplement for Heart Failure
Columbus, OhioThis study is being done to evaluate how a ketone ester (KE) beverage affects heart function and health in people with heart failure compared to a placebo beverage (a beverage made with standard food ingredients that do not contain ketone esters).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Type I Diabetes, Severe Kidney Disease, Recent Myocardial Infarction, Others
Must Not Be Taking:SGLT2 Inhibitors
30 Participants Needed
Black Impact Intervention for Cardiovascular Health
Columbus, OhioLower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Physical Activity Limitations
340 Participants Needed
Dietary and Behavioral Changes for Metabolic Syndrome
Columbus, OhioTo determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Digestive Illnesses, Psychiatric Illness, Pregnancy, Others
100 Participants Needed
Tart Cherry Supplement for Metabolic Syndrome
Athens, OhioMetabolic syndrome (MetSyn) is a growing health concern, with up to 25% of the worlds population having the syndrome. MetSyn is a primary risk factor for cardiovascular disease and type II diabetes development, and is independently associated with all-cause mortality, making it an important disease target. The primary treatment for MetSyn is exercise and weight loss, along with medically necessary treatment. Exercise, along with dietary changes such as increased fiber and polyphenol intake can positively impact many of the metabolic abnormalities seen with MetSyn. For example, polyphenols have been shown to decrease lipid concentration and improved glucose clearance as well as decreased oxidative stress and inflammation. Powdered tart cherry capsules, which contain the skin of the fruit, provides polysaccharides (fiber) that would likely act as a substrate for gut bacteria degradation, providing energy substrates and barrier integrity to the colonocytes and increasing the bioavailability of the polyphenols to other cells in the body. However there have been no long-term investigations into the use of powdered tart cherry supplements in MetSyn, therefore we aim to determine if 60 days tart cherry supplementation modify criteria for MetSyn in currently diagnosed individuals including body mass, waist circumference, blood pressure, blood lipid levels and blood glucose control.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Inflammatory Conditions, Organ Failure, Smoking, Others
Must Not Be Taking:Glucose Control, Statins, Anti-inflammatories
30 Participants Needed
TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55+
Sex:All
Key Eligibility Criteria
Disqualifiers:Symptomatic CVD, Kidney Disease, Thyroid Cancer, Others
7500 Participants Needed
Medically Tailored Meals for Metabolic Health
Cleveland, OhioThis study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Heart Failure, Type I Diabetes, Others
75 Participants Needed
Time-Restricted Eating for Metabolic Syndrome in Postmenopausal Women
Lexington, KentuckyThis is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Heart Disease, Psychiatric Disorders, Others
Must Not Be Taking:ADHD Medications
164 Participants Needed
Lifestyle Interventions for Obesity
Pittsburgh, PennsylvaniaThis is a multisite clinical trial of healthy lifestyle programs for middle-to-older-aged adults (50 -74 years) to improve their weight and, therefore, reduce risk for chronic disease. This study will investigate whether a proven, self-directed video-based lifestyle program can be significantly enhanced with the assistance of a coach via videoconference or phone to help people as they adopt healthy eating and exercise behaviors. Additionally, the study will examine what factors might explain why some people achieve better outcomes than others. Understanding this can help to tailor the program to an individual for personalized care in the future.
Importantly, this study aims to demonstrate how readily a digital lifestyle program, with or without remote coaching, can be seamlessly delivered to patients at home via the patient portal of their electronic health record. This practical use of existing telehealth tools could be a feasible and effective means to offer behavioral treatments during routine medical care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 74
Sex:All
Key Eligibility Criteria
Disqualifiers:Eating Disorders, Bariatric Surgery, Cancer, Others
Must Not Be Taking:Weight Loss Medications
1029 Participants Needed
Exercise for Obesity Management
Ann Arbor, MichiganParticipants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Metabolic, Tobacco, Others
Must Not Be Taking:Lipid/glucose Metabolism, Inflammation
46 Participants Needed
Air Purification for Cardiovascular Health in Seniors
Ann Arbor, MichiganExposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
55 Participants Needed
Exercise for Weight Loss
Ann Arbor, MichiganStudy Purpose:
The combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment/prevention of obesity-related diseases.
Although a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained
Study Summary:
10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:
1. Moderate Intensity Continuous Training (MICT) exercise group
2. No exercise (control) group
Follow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise/physical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.
Total involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Tobacco, Others
Must Not Be Taking:Lipid/glucose Metabolism Drugs
68 Participants Needed
Low-Sodium, High-Quality Diet for Heart Failure Prevention
Ann Arbor, MichiganTens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45+
Sex:All
81 Participants Needed
Mibavademab for Fat Loss Syndrome
Ann Arbor, MichiganThis study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.
The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin.
The study is looking at several other research questions, including:
* What side effects may happen from taking mibavademab
* How much mibavademab is in the blood at different times
* Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2+
Sex:All
Key Eligibility Criteria
Disqualifiers:Malignancy, Heart Failure, Low GFR, Others
Must Be Taking:Metreleptin
8 Participants Needed
Reduced-Intensity Stem Cell Transplant for Non-Malignant Disorders
Pittsburgh, PennsylvaniaThe objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) in patients with non-malignant disorders that are amenable to treatment with hematopoietic stem cell transplant (HSCT). After transplant, subjects will be followed for late effects and for ongoing graft success.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:2 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Malignancy, Severe Aplastic Anemia, Others
100 Participants Needed
Lifestyle Interventions for Chronic Disease
Lewisburg, West VirginiaDeveloped nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 64
Sex:All
95 Participants Needed
INV-202 for Obesity and Metabolic Syndrome
Sarnia, OntarioThe study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with obesity and metabolic syndrome.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
243 Participants Needed
RIC + BMT for Non-Malignant Disorders
Grand Rapids, MichiganThis study is designed to estimate the efficacy and toxicity of familial HLA mismatched bone marrow transplants in patients with non-malignant disease who are less than 21 years of age and could benefit from the procedure.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:1 - 21
Sex:All
Key Eligibility Criteria
Disqualifiers:HLA-identical Sibling Donor, Cirrhosis, Uncontrolled Infection, HIV, Others
29 Participants Needed
Bariatric Surgery for Obesity
Chicago, IllinoisThe purpose of this study is to understand how daily rhythms of behavior affect the expression of genes in fat cells, and how these daily cycles affect the way fat cells respond to insulin (a hormone that controls blood sugar levels) before and after bariatric surgery.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:Female
82 Participants Needed
Physical Activity for Breast Cancer
Chicago, IllinoisThis study aims to to improve physical activity and metabolic outcomes for breast cancer prevention in South Asian Indian immigrant women.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:40 - 65
Sex:Female
96 Participants Needed
Exercise + Liraglutide for Metabolic Syndrome
Charlottesville, VirginiaThe primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and skeletal muscle microvascular blood volume, improves vascular function of the conduit vessels, and enhances insulin's metabolic action in humans with Metabolic Syndrome. Subjects will be randomized to one of the 4 groups: control, exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 24 weeks of intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:21 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Smoking, Hypertriglyceridemia, Others
Must Not Be Taking:Diabetes Medications, Liraglutide
80 Participants Needed
Health Coaching for Heart Disease
Chicago, IllinoisThe goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are:
* Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke?
* Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes?
* Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare?
Researchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors.
Participants will:
* Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6.
* Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare
* Keep a log of their blood pressure
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:40 - 75
Sex:All
200 Participants Needed
MIND Diet for Brain and Heart Health
Urbana, IllinoisThe goal of this clinical trial is to learn if increasing adherence to a Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet pattern improves brain and heart health relative to a healthy control diet in middle-aged adults. Our research team will evaluate three different groups: the first group will be chosen using a predictive analytics model that predicts who will benefit most from the MIND diet, the second group will follow the MIND diet without being pre-selected, and the third group will eat a standard healthy diet to serve as a comparison.
The main questions it aims to answer are:
Does the MIND diet improve cognitive performance and heart health relative to a control diet? How does the health impact of the MIND diet in participants pre-identified through predictive analytics compare to those without such pre-selection? Which of the three groups - predictive analytics selected MIND diet group, standard MIND diet group, or healthy control - demonstrate the most significant improvements in cognitive and cardiovascular health over the course of the trial?
Participants will:
Consume one meal that follows the MIND diet or a control meal every day for 3 months. Visit the lab before and after the 3 months of meals for tests. Keep a record of the food they eat during the study.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 64
Sex:All
Key Eligibility Criteria
Disqualifiers:Liver Disease, Gastrointestinal Disease, Neurological Disease, Others
Must Not Be Taking:Oral Hypoglycemics, Insulin
72 Participants Needed
Non-Physician Health Worker Support for Metabolic Syndrome
Hamilton, OntarioThis study is a substudy of the Strenghtening Community Roots (SCORE!) Cohort study. The investigators will look for people, enrolled in the SCORE! Cohort study, with abnormal results related to blood sugar and fat, as well as high blood pressure and heart disease risks. The investigaors will try to help the community improve sugar, fat and blood pressure through trained people who are not necessarily a medical doctor but have health-sciences-training backgrounds. These people are called Non-Physician Health Workers (NPHW), and they will be under the direction of a medical doctor and will be also in close communication with the participants and the medical doctor to improve their health. This will happen through a total of 12 months, having online and on-site visits, for follow-up.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
137 Participants Needed
Soy Milk for Metabolic Health
Toronto, OntarioStrategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 75
Sex:All
186 Participants Needed
Motor Memory Assessment for Post-COVID Syndrome
Bethesda, MarylandBackground:
Most people who get COVID-19 seem to recover with no long-term effects. However, some people who recover from acute COVID-19 infections report lingering symptoms. This is called long COVID. Many people with long COVID report symptoms related to the nervous system; these can include problems with fatigue, speech, and memory.
Objective:
To test motor memory in people with long COVID, compared to healthy volunteers.
Eligibility:
People aged 18 to 90 years who are also enrolled in study protocol 000089. Healthy adults are also needed.
Design:
Participants will be screened by telephone. They will confirm they are able to type without discomfort using their nondominant hand. They will confirm they have access to a computer connected to the internet.
All study tasks will be done online. Participants will complete 2 tasks in 2 days.
Participants will be sent a link to a website. The website will give them instructions. They will place the fingers of their nondominant hand over 4 numbers on the keyboard and type a sequence (eg, 4-1-3-2-4). They will type this sequence as often as they can in 10 seconds. Then they will rest for 10 seconds before repeating the task. They will repeat this pattern for 15 minutes.
After they finish the typing task, participants will take a 10-minute questionnaire. They will answer questions about their experiences with COVID-19 and memory issues; they will say which hand they use for tasks such as brushing their teeth or throwing a ball.
Participants will get a notice to repeat the typing task 22 hours after they finish the first one. They should complete the second task within 28 hours....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 90
Sex:All
1000 Participants Needed
Burosumab for Fibrous Dysplasia
Bethesda, MarylandBackground:
Fibrous dysplasia (FD) is a disorder that affects bone growth. Affected bone tissue is weakened, and people with FD are prone to deformities, fractures, and other problems. People with FD may also have low blood phosphate levels. This can make bones even weaker. Better treatments are needed.
Objective:
To test a study drug (burosumab) in people with FD who have low blood phosphate levels.
Eligibility:
People aged 1 year or older who have FD and low blood phosphate levels.
Design:
Participants will visit the NIH 3 times in 48 weeks. Each visit will last 5 to 7 days.
Participants will self-inject burosumab under the skin in their belly, upper arm, or thigh. They (or a caregiver) will do this at home 1 or 2 times a month. They will be trained in person on how to inject the drug. Home injections will be guided via telehealth.
During NIH visits, participants will have a physical exam with blood and urine tests. They will have x-rays of different parts of their body. They will have a radioactive tracer injected into their vein; then they will have a bone scan. They will have tests to assess their strength, walking, and movement. They will complete questionnaires about their pain, mobility, and fatigue levels.
Adult participants may have bone biopsies. These will be done under anesthesia with sedation. Small samples of FD-affected bone will be removed for study.
Between NIH visits, participants will go to a local laboratory for blood and urine tests.
Child participants will have an additional follow-up visit 2 weeks after the final NIH visit.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:1 - 99
Sex:All
12 Participants Needed
Exercise Programs for High-Risk Metabolic Syndrome
Washington, District of ColumbiaAmong African-American women, in whom metabolic syndrome (MetS) is very prevalent and breast cancer mortality rates are high, it is hypothesized that intervening on MetS to improve the MetS profile may prove to be a means to reduce breast cancer risk. Specific recommendations for breast cancer prevention are now focused on maintaining a healthy weight via increased physical activity levels, and losing weight if overweight or obese.
This pilot project compares two exercise interventions: a supervised facility-based and a home-based exercise intervention to a control group in African-American women with metabolic syndrome who are at high risk for breast cancer. This study is a 6-month three-arm RCT to assess the impact of the exercise interventions on biomarkers related to obesity, insulin-related pathways, inflammation, hormones, and micro-RNAs.
The specific aim of the proposed study is to compare the impact of a supervised facility-based and a home-based exercise intervention on obesity, metabolic syndrome and known breast cancer biomarkers in postmenopausal African-American women with metabolic syndrome who are at increased risk of breast cancer.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:45 - 65
Sex:Female
213 Participants Needed
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Frequently Asked Questions
How much do Metabolic Syndrome clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Metabolic Syndrome clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Metabolic Syndrome trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Metabolic Syndrome is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Metabolic Syndrome medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Metabolic Syndrome clinical trials ?
Most recently, we added Lactate and Ischemic Preconditioning for Vascular Injury, Mindfulness Therapy for Insomnia and Urea in Dialysis Fluid for Renal Disease to the Power online platform.