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45 Polycystic Ovary Syndrome Trials
Power is an online platform that helps thousands of Polycystic Ovary 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.
Insulin Management for Non-alcoholic Fatty Liver Disease
New York, New YorkThis is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
36 Participants Needed
Ovarian Tissue Transplantation for Premature Ovarian Failure
Cleveland, OhioPremature ovarian failure, also known as primary ovarian insufficiency (POI), or premature menopause, affects 1-2% of women under 40. The diagnosis is typically made based on high levels of follicle stimulating hormone (FSH) and absent or irregular menstrual periods. It leads to infertility and menopause-like effects (hot flashes and thin bones) due to low estrogen levels. POI can result from various factors such as genetic conditions, autoimmune diseases, or previous medical treatments like chemotherapy.
Treatment of POI usually involves hormone replacement therapy and, if pregnancy is desired, assisted reproductive technologies such as in vitro fertilization (IVF) using an egg donor. However, IVF may not be an option for everyone due to personal, religious, ethical or financial reasons. Recent advances in medicine have identified ovarian tissue transplantation (OTT) as a potential solution. OTT involves transplanting either fresh or frozen ovarian tissue into the pelvic area, where it can begin functioning again. Studies in animals and humans have shown success in restoring hormonal function and even achieving pregnancies in some cases. Initial human trials of ovarian tissue transplants from another individual began with identical twins and have since expanded to include non-identical siblings with compatible tissue matches using immunosuppression. Success rates of OTT have been promising, with multiple live births reported between identical twins. Long-term studies indicate that transplanted tissue can remain functional for up to eight years. Ovarian tissue transplantation offers a promising avenue for women with POI to help restore fertility and hormonal function. Continued research and refinement of tissue techniques are essential to improve outcomes and expand access to this innovative treatment option.
This study will enroll 10 participants who will undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol at University Hospitals.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:21 - 40
Sex:Female
10 Participants Needed
Exercise Training for Aging
Durham, North CarolinaThe primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (Parent trial: STRRIDE-PD; NCT00962962). This feasibility pilot study will enroll up to 8 participants to complete a 6-month aerobic exercise intervention.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:60 - 90
Sex:All
8 Participants Needed
Oral Contraceptives + Resistant Starch for Polycystic Ovary Syndrome
Philadelphia, PennsylvaniaThis study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 40
Sex:Female
100 Participants Needed
Lifestyle Intervention for Preventing Type 2 Diabetes
Salt Lake City, UtahNearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
324 Participants Needed
Heat Therapy for Prediabetes
Lubbock, TexasThe main goal of this two-phase clinical trial is to learn whether local heat therapy, using heat pads applied to the legs, can enhance skeletal muscle health, physical function, and blood sugar control in a manner comparable to exercise, specifically High-Intensity Interval Training (HIIT), in older individuals with prediabetes. The study aims to answer the following questions:
1. Does local heat therapy improve muscle architecture (e.g., muscle cross-sectional area, capillary density, mitochondrial content), glucose tolerance, and frailty indicators similarly to HIIT in older individuals with prediabetes?
2. Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:60+
Sex:All
54 Participants Needed
Ketone Supplementation for Polycystic Ovary Syndrome
Montréal, QuebecPolycystic ovary syndrome (PCOS) affects 1 in 5 females of reproductive age. Commonly characterized as a disorder of infertility, PCOS is often accompanied by 3 potent cardiovascular disease (CVD) risk factors: insulin resistance, endothelial dysfunction, and elevated blood pressure. Accordingly, PCOS is associated with the development of CVD, the second leading cause of death in females in Canada. However, effective treatments to improve cardiovascular health in PCOS are lacking.
Exogenous ketone monoester (KME) ingestion has been shown to improves outcomes associated with insulin resistance, endothelial function, and blood pressure regulation in healthy individuals and individuals predisposed to CVD. Therefore, oral ketone supplements offer a practical and effective strategy for improving cardiovascular health; however, this treatment has yet to be evaluated in PCOS.
Therefore, the overall goal of this project is to employ KME ingestion to improve markers of cardiovascular health in females with PCOS.
On two different days, participants will consume either a beverage containing a ketone supplement or a beverage containing a placebo supplement. The objectives are to compare responses between KME and placebo ingestion, and examine all outcomes related to cardiovascular health in females with PCOS in comparison with female controls of similar age and body mass index. The effects of KME ingestion will be quantified on: 1) glycemic control during an oral glucose tolerance test; 2) endothelial function using the flow-mediated dilation test; 3) blood pressure and acute blood pressure regulation; and 4) hemodynamic responses to acute exercise.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:All
Key Eligibility Criteria
Disqualifiers:Smoking, Cardiometabolic Disease, Pregnancy, Others
Must Not Be Taking:Anti-hypertensives, Anti-androgens, Metformin
60 Participants Needed
Semaglutide for Polycystic Ovary Syndrome
Dallas, TexasThe purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female
85 Participants Needed
Fasting-Mimicking Diet for Prediabetes
Irvine, CaliforniaThis is a pilot study to determine the feasibility of studying the Fasting-Mimicking Diet (FMD), a dietary approach that involves the consumption of a specifically formulated, calorie-restricted nutrition regimen with a customized macronutrient composition, ratio, and quantity over a 5- day period, on a larger scale in Asian Americans with prediabetes and to examine the preliminary effects of the diet in study participants.
The main questions the study aims to answer are:
1. What are the recruitment, adherence, and attrition rates of eligible participants into the study?
2. Does one FMD cycle result in changes in fasting blood glucose levels and physical measurements in study participants?
Participants will be asked to undergo one cycle of FMD (for 5 days), fill out surveys, and come in for a pre-FMD and post-FMD study visit, during which physical measurements and fasting blood glucose and ketone levels will be measured.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 65
Sex:All
30 Participants Needed
Alpelisib for Insulin Resistance
New York, New YorkThe goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.
The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular, Liver, Psychiatric, Others
Must Not Be Taking:Antidiabetics, Lipid-lowering, Antipsychotics, Corticosteroids
32 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
Weight Loss Program for PCOS and Obesity
Ottawa, OntarioThe goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?
Participants will complete a 24-week weight loss program (STREAM). During this program they will:
* weigh themselves
* complete regular bloodwork and
* fill out a Quality of Life questionnaire at regular intervals
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:Female
20 Participants Needed
Transvaginal Ablation for Polycystic Ovary Syndrome
Hershey, PennsylvaniaA Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, BMI > 40, Hyperandrogenism, Poor Glycemic Control, Others
Must Not Be Taking:Anticoagulants, Ovulation Inducers
195 Participants Needed
Zinc for Prediabetes
Lancaster, PennsylvaniaThe purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo.
Specific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \[mg\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnant, Cancer, Liver Disease, Others
Must Not Be Taking:Corticosteroids, Antipsychotics, Protease Inhibitors, Others
200 Participants Needed
Bicalutamide for NAFLD and PCOS
San Francisco, CaliforniaThis trial tests bicalutamide, a medication that blocks certain hormones, in women with NAFLD and PCOS. The goal is to see if it can reduce liver damage by stopping harmful hormone effects.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Alcohol Use, Liver Disease, Others
Must Not Be Taking:Steroids, Valproic Acid, Others
50 Participants Needed
Time-Restricted Eating for Type 2 Diabetes
Toronto, OntarioThis study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
120 Participants Needed
Continuous Glucose Monitoring for Polycystic Ovary Syndrome
San Francisco, CaliforniaThis trial uses a wearable device to monitor blood sugar levels in women with PCOS. The goal is to see if continuous monitoring can help manage their blood sugar and improve their overall health. The study will compare results from those using the device to those who do not. These devices were primarily developed for individuals with diabetes but are now being used by people without diabetes for various health applications.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type I/II Diabetes, Others
Must Not Be Taking:Metformin, Anti-diabetics
56 Participants Needed
Semaglutide for Polycystic Ovary Syndrome
Aurora, ColoradoThis trial involves girls and women aged 12-35 with obesity and PCOS taking a medication that helps manage blood sugar and promote weight loss. The goal is to see if this treatment can improve their weight and reproductive health.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 35
Sex:Female
Key Eligibility Criteria
Disqualifiers:Thyroid Cancer, Diabetes, Pregnancy, Others
Must Be Taking:Metformin
80 Participants Needed
Kisspeptin for Polycystic Ovary Syndrome
Boston, MassachusettsThis trial involves giving kisspeptin and another hormone to people with PCOS to see how it affects their hormone levels. The goal is to understand if kisspeptin can help regulate their reproductive hormones. Kisspeptin has recently emerged as a key regulator of the reproductive system in women and has been shown to stimulate the secretion of another important hormone.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Excessive Alcohol, Illicit Drugs, Others
Must Not Be Taking:Hormonal Medications
4 Participants Needed
Insulin Infusion for Non-alcoholic Fatty Liver Disease
New York, New YorkThis is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the specific dose-response impact of insulin infusion rate (IIR) on blood glucose levels during a pancreatic clamp study. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance \[HOMA-IR\] score \>=2.73), and with evidence of, or clinically judged to be at high risk for, uncomplicated non-alcoholic fatty liver disease (NAFLD). Participants will undergo two pancreatic clamp procedures in which individualized basal IIR are identified, followed in one by maintenance of basal IIR (maintenance hyperinsulinemia, MH) and in the other by a stepped decline in IIR (reduction toward euinsulinemia, RE). In both clamps the investigators will closely monitor plasma glucose and various metabolic parameters. The primary outcome will be the absolute and relative changes in steady-state plasma glucose levels at each stepped decline in IIR.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular, Liver, Others
Must Not Be Taking:Antidiabetics, Corticosteroids, Opioids, Others
42 Participants Needed
Diazoxide for Non-alcoholic Fatty Liver Disease
New York, New YorkThe goal of this clinical trial is to compare a two-week course of diazoxide (at two different doses) and placebo in people with overweight/obesity and insulin resistance (IR) with, or at high risk for, non-alcoholic fatty liver disease (NAFLD). The main questions it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects parameters of glucose and lipid metabolism (how people with IR and NAFLD respond to lowering high insulin levels so that the investigators can see what happens to how the liver handles fat and sugar).
Participants will:
* Take 27 doses of diazoxide (at 1 mg per kg of body weight per dose \[mpk\] or 2 mpk) or of placebo, over 14 days
* Take 32 doses of heavy (deuterated) water (50 mL each) over 14 days
* Have blood drawn and saliva collected after an overnight fast on four mornings over the two-week study period
* Consume their total calculated daily caloric needs as divided into three meals per day
* Wear a continuous glucose monitor for the two-week study period
Researchers will compare fasting blood tests at intervals during the study period in participants randomized (like the flip of a coin) to diazoxide 1 mpk, diazoxide 2 mpk, or placebo, to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B). They will also consume heavy (deuterated) water to assess de novo lipogenesis (building of new fatty acids by the liver).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Disease, Liver Disease, Others
Must Not Be Taking:Antidiabetics, Lipid-lowering, Vasodilators, Others
72 Participants Needed
Small Steps for Big Changes Program for Prediabetes
Kelowna, British ColumbiaThis trial evaluates the effectiveness of the 'Small Steps for Big Changes' (SSBC) program, designed to help people with prediabetes improve their diet and exercise habits. The goal is to see if these changes can lower blood sugar levels, reduce weight, and decrease waist size over time. Participants receive personalized guidance and support from trainers at YMCA locations. The 'Small Steps for Big Changes' (SSBC) program emphasizes behavior change techniques and motivational interviewing to help adults at risk for type 2 diabetes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
250 Participants Needed
Cognitive Behavioral Therapy for Prediabetes
Portland, OregonThis study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:22 - 79
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, OSA, Epilepsy, Others
Must Not Be Taking:Hypoglycemics, Weight Loss Meds
300 Participants Needed
Metformin for Prediabetes
Cincinnati, OhioThis trial is testing whether metformin can lower the risk of death, heart attacks, and strokes in people with pre-diabetes and heart or blood vessel issues. Metformin is a drug that helps control blood sugar levels and has been used to treat type 2 diabetes mellitus for more than 60 years. The study involves patients who have pre-diabetes and existing heart or blood vessel problems, aiming to see if metformin can provide additional health benefits.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Cirrhosis, Hypertension, Others
Must Not Be Taking:Metformin, Glucocorticoids, Cimetidine, Others
7410 Participants Needed
In Vitro Maturation for Infertility
Lone Tree, ColoradoCCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 38
Sex:Female
Key Eligibility Criteria
Disqualifiers:More Than 2 Failed IVF Cycles
50 Participants Needed
Time Restricted Eating for Polycystic Ovary Syndrome
Chicago, IllinoisBackground: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS.
Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity.
Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 40
Sex:Female
300 Participants Needed
CPAP for Polycystic Ovary Syndrome
San Francisco, CaliforniaIn this study, the researchers are trying to learn more about the relationship between Polycystic Ovary Syndrome and Obstructive Sleep Apnea (OSA). Obstructive Sleep Apnea is a sleep-related breathing disorder that involves a decrease or complete stop in airflow. The purpose of this study is to find out why some people with obstructive sleep apnea have higher levels of insulin resistance, and the investigators will study the role of hypoxia (low levels of oxygen in the blood at night) in insulin resistance and see if insulin resistance improves during your treatment with CPAP.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Tobacco, Alcohol, Others
Must Not Be Taking:Oral Contraceptives, Asthma Treatment
20 Participants Needed
Hormone Therapy for Polycystic Ovary Syndrome
Charlottesville, VirginiaThis trial is testing if flutamide, which blocks testosterone, can help women with PCOS improve their hormone regulation. The study aims to see if this medication can enhance the body's response to progesterone. Flutamide has been used to treat high levels of male hormones in women with PCOS, but its use is limited by potential liver damage and cost.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 30
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Liver Abnormalities, Cancer, Others
Must Not Be Taking:Systemic Corticosteroids
10 Participants Needed
Empagliflozin for Prediabetes
Corvallis, OregonThe overall purpose of this study is to identify how empagliflozin (a drug commonly used to treat type 2 diabetes) impacts skeletal muscle metabolic health among adults with prediabetes. Our aims are to: 1) Test the ability of empagliflozin to improve regulation of glucose metabolism (i.e., blood sugar) among overweight and obese individuals at risk for diabetes, and 2) Identify mechanisms to explain how empagliflozin may improve skeletal muscle glucose metabolism. We hypothesize empagliflozin will improve regulation of glucose metabolism due to changes in whole-body and skeletal muscle metabolism (e.g., increased rates of whole-body fat oxidation, evidence of impaired skeletal muscle mitochondrial respiratory function and increased energetic stress, lower accumulation of skeletal muscle lipids and improved skeletal muscle insulin signaling compared with placebo treatment).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 59
Sex:All
Key Eligibility Criteria
Disqualifiers:Regular Exercise, Pregnancy, Smoking, Major Metabolic, Others
Must Not Be Taking:Glucose-lowering, MAO Inhibitors, Beta-blockers, Diuretics
40 Participants Needed
DASH vs Low-Carb Diet for Polycystic Ovary Syndrome
Ann Arbor, MichiganThis trial is comparing two diets, the DASH diet and a very low-carbohydrate diet, to see which one better helps adults with polycystic ovary syndrome (PCOS) manage their blood sugar and weight. The DASH diet focuses on healthy foods to lower blood pressure, while the very low-carb diet cuts down on sugars to control blood sugar and weight.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Menopause, Pregnancy, Renal Disease, Others
Must Not Be Taking:Weight Loss Drugs, Psychostimulants, Corticosteroids, Warfarin
214 Participants Needed
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Frequently Asked Questions
How much do Polycystic Ovary 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 Polycystic Ovary 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 Polycystic Ovary 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 Polycystic Ovary 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 Polycystic Ovary 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 Polycystic Ovary Syndrome clinical trials ?
Most recently, we added Insulin Management for Non-alcoholic Fatty Liver Disease, Ovarian Tissue Transplantation for Premature Ovarian Failure and Exercise Training for Aging to the Power online platform.
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