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116 Metabolic Syndrome Trials near Fort Myers, FL
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.
Learn More About PowerHaploidentical HCT for Primary Immunodeficiency
Saint Petersburg, FloridaThis research is being done to learn if a new type of haploidentical transplantation using TCR alpha beta and CD19 depleted stem cell graft from the donor is safe and effective to treat the patient's underlying condition. This study will use stem cells obtained via peripheral blood or bone marrow from parent or other half-matched family member donor. These will be processed through a special device called CliniMACS, which is considered investigational.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:< 21
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, HIV, Uncontrolled Infections, Others
17 Participants Needed
Cleerly CAD Staging System for Preventing Heart Disease
Boca Raton, FloridaTRANSFORM 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
Signos mHealth Platform for Weight Loss
North Miami, FloridaThis trial uses a device that continuously tracks blood sugar levels and a mobile app to help people with obesity manage their weight. The app provides personalized advice on diet and exercise based on the blood sugar data. The goal is to see if this approach helps people stick to their health goals better.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:22+
Sex:All
380 Participants Needed
AMG 513 for Obesity
Aventura, FloridaThe primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
80 Participants Needed
Educational Modules for Spinal Cord Injury
Miami, FloridaThe purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cognitive Impairment, Pressure Injury, Prisoners
250 Participants Needed
Tributyrin for Health and Performance
Tallahassee, FloridaThe purpose of this study is to determine if tributyrin supplementation improves metabolite concentrations, overall health biomarkers, and performance in sedentary men and women. The study would further understand the potential usage of tributyrin as a health and performance increasing supplement through improving gut and immune health, sleep, and performance as well as reduce inflammation. Participants will supplement for tributyrin for 4 weeks and complete fecal metabolite measures, cardiovascular evaluation, sleep assessment, and exercise testing as well as provide blood samples.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Metabolic, Cardiovascular, Gastrointestinal, Others
Must Not Be Taking:Microbiome Supplements
20 Participants Needed
Family-Based Obesity Intervention for Childhood Obesity
Charleston, South CarolinaThis trial tests the FIT Families program, which helps African American teens and their families adopt healthier habits through regular visits, motivational talks, and practical skills training. It targets obese African American adolescents aged 12-17 because they have high rates of obesity and related health issues. The program aims to reduce obesity by encouraging healthy behaviors and providing support at home. The FIT Families program integrates cultural tailoring, positive parenting, and motivational strategies to help African American adolescents reduce obesity.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12+
Sex:All
360 Participants Needed
Genotype-Guided Diet and Exercise for Cardiometabolic Health
Birmingham, AlabamaNatriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have \~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have \~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Diseases, Pregnancy, Others
Must Not Be Taking:Antidiabetics, Hypertension Meds
200 Participants Needed
Spiced Yogurt for Metabolic Health
Tuscaloosa, AlabamaAmong food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 69
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Cancer, Others
Must Not Be Taking:Steroids, Antibiotics
30 Participants Needed
Overfeeding Effects on Obesity
Baton Rouge, LouisianaAdipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 42
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Organ Disease, Others
Must Not Be Taking:Steroids, Antipsychotics, Antidepressants, Others
58 Participants Needed
Stem Cell Therapy for Inherited Metabolic Brain Diseases
Durham, North CarolinaThe primary objective of the study is to determine the safety and feasibility of intrathecal administration of DUOC-01 as an adjunctive therapy in patients with inborn errors of metabolism who have evidence of early demyelinating disease in the central nervous system (CNS) who are undergoing standard treatment with unrelated umbilical cord blood transplantation (UCBT). The secondary objective of the study is to describe the efficacy of UCBT with intrathecal administration of DUOC-01 in these patients.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:1 - 22
Sex:All
Key Eligibility Criteria
Disqualifiers:Prior Transplant, Seizures, HIV, Others
Must Not Be Taking:Immunosuppressives, Chemotherapy
40 Participants Needed
Empagliflozin for Obesity-Related Inflammation
Nashville, TennesseeObesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This trial will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Cardiovascular Disease, Neurologic Disease, Others
Must Not Be Taking:Anti-diabetics, Glucocorticoids, Anticoagulants, Others
74 Participants Needed
The overall purpose of this study is to learn more about the metabolic effects of angiotensin-(1-7) in the insulin resistant state associated with obesity. Pharmacologic approaches to increase angiotensin-(1-7) levels or its actions are currently in development for treatment of metabolic-related diseases such as obesity and type II diabetes, based on findings from animal studies. It is unclear if this peptide contributes to the regulation of metabolism in humans. The investigators will test if angiotensin-(1-7) infusion can improve insulin sensitivity measured by hyperinsulinemic-euglycemic clamp methods in individuals with obesity and insulin resistance. The investigators will also examine for changes in blood pressure and related hemodynamic and hormonal changes following angiotensin-(1-7) infusion.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Disease, Renal Impairment, Others
Must Not Be Taking:SNRIs, NET Inhibitors, Anticoagulants, Others
19 Participants Needed
Probiotic + Prebiotic for Fatty Liver in HIV/AIDS
Nashville, TennesseePersons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 89
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Celiac, Hepatitis C, Others
Must Be Taking:Antiretrovirals
63 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
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
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
Age:21 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Smoking, Hypertriglyceridemia, Others
Must Not Be Taking:Diabetes Medications, Liraglutide
80 Participants Needed
Brighter Bites for Childhood Obesity
Houston, TexasThe purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 9
Sex:All
Key Eligibility Criteria
Disqualifiers:Special Needs, Physical, Cognitive, Psychological, Others
720 Participants Needed
Carnitine Supplementation for Arterial Stiffness
Houston, TexasHardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:11 - 21
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure Disorder, Renal Failure, Diabetes, Others
90 Participants Needed
Paso Program for Fatty Liver Disease
Houston, TexasThe purpose of this study is to learn whether the Paso weight loss program is feasible for Mexican and Central American patients with fatty liver disease. In addition, the investigators will also look at whether the program improves weight loss, fatty liver disease, physical activity, diet, and family support among patients.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Advanced Liver Disease, Organ Transplant, Heavy Alcohol Use, Active Cancer, Others
Must Not Be Taking:SGLT2 Inhibitors, GLP-1 Agonists
50 Participants Needed
Exercise Program + Fitbit Monitoring for Prostate Cancer
Houston, TexasThis phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Heart Disease, Symptomatic Bone Metastasis, Others
Must Be Taking:GnRH Agonists/antagonists
200 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
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
Plant-based Diet for Kidney Transplant Recipients
Washington, District of ColumbiaThe goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows:
* To test the feasibility of transiting renal allograft recipients who are \> 3 months post-transplant to a PBD
* To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients
* To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients
Participants will be asked to:
* Complete a 2-week investigator-designed PBD transition program
* Follow a PBD for a minimum of 16 weeks
* Consent for blood draws, urine samples, and fecal samples along with physical exams
* Complete intermittent food frequency questionnaires and quality of life questionnaires
* Periodically meet with investigators and other study participants
Researchers will compare baseline measurements with future measurements for each participant.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:18 - 80
Sex:All
25 Participants Needed
Mibavademab for Fat Loss Syndrome
Bethesda, MarylandThis 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
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
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
Age:1 - 99
Sex:All
12 Participants Needed
Ketone Ester for Metabolic Syndrome
Baltimore, MarylandBackground:
In Alzheimer s disease (AD) the brain cannot use glucose as a fuel. The brain can use ketones as a fuel instead of glucose. Researchers want to test a supplement, Ketone Ester (KE). It may improve brain metabolic function and cognition in normal people and, perhaps, down the road, in patients with AD.
Objective:
To study the change in brain ketone levels in people after 28 days of taking KE compared with baseline and placebo. Also, to study changes in cognitive performance.
Eligibility:
People 55 years old or older with metabolic syndrome and no cognitive impairment
Design:
Participants will have 4 visits.
Participants will be screened at Visit 1 with:
Medical history
Physical exam
Blood and urine tests
Cognitive testing
Participants will be randomly assigned to receive either the study supplement or a placebo with same amount of calories. Neither they nor the researchers will know which they receive.
Visit 2 will include repeats of some screening tests. It will also include:
Stool sample (brought from home)
MRI/MRS: Participants will lie on a table that slides in and out of a scanner. A coil will be placed over their head. They may be asked to perform leg exercises.
First dose of study supplement or placebo
About 2 weeks after Visit 2, Visit 3 will include blood and urine tests and a questionnaire.
About 2 weeks after Visit 3, Visit 4 will include repeats of the Visit 2 tests.
Participants will drink the study supplement or placebo 3 times per day during the study. They will keep a daily log of each dose. They will bring the log to Visits 3 and 4.
Participants will by contacted by phone once per week during the study to see how they are doing.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Brain Disorders, Psychiatric Conditions, HIV, Pregnancy, Others
Must Be Taking:Triglycerides, HDL, Blood Pressure, Glucose
150 Participants Needed
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
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
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Frequently Asked Questions
How much do Metabolic Syndrome clinical trials in Fort Myers, FL 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 in Fort Myers, FL 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 in Fort Myers, FL 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 in Fort Myers, FL 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 in Fort Myers, FL 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 in Fort Myers, FL ?
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 in Fort Myers, FL ?
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.