Bethesda, MDNCT03049462Now EnrollingIRB Ready

Polycystic Ovary Syndrome Clinical Trial in Bethesda, MD

Access cutting-edge polycystic ovary syndrome treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Expert Care in Bethesda

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related polycystic ovary syndrome treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Polycystic Ovary Syndrome Study in Bethesda

Background: Brown adipose tissue (BAT) is a type of fat in the body. It may prevent weight gain, improve insulin sensitivity, and reduce fatty liver. Researchers want to see if BAT helps the body burn energy. Objective: To learn more about how BAT works to burn energy. Eligibility: People ages 18-40 with a body mass index between 18 and 40 Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Dietitian interview Participants will have an overnight baseline visit. This includes: Repeats of screening tests Exercise test Scans. For one scan, a radioactive substance is injected into the arm. FSIVGIT: An IV is inserted into veins in the right and left arms. Glucose and insulin are injected in one arm. Blood glucose and insulin levels are measured from the other. Metabolic suite: Participants stay 18-19 hours in a room that measures their metabolic rate. Monitors on the body measure heart rate, movement, and temperature. Optional fat biopsy: A small piece of tissue is removed with a needle. Participants will take 2-4 pills daily for 4 weeks. All women will take the drug mirabegron. Men will be randomly get either the drug or a placebo. All participants will have a visit after 2 weeks of the pills. They will repeat the screening tests. Participants will have an overnight visit 2 weeks later. They will repeat the baseline tests. Participants will keep food and medication diaries. Participants will have a follow-up visit 2 weeks after stopping the pills. This includes heart tests.

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria: Cohort 1: (complete)
Age 18-40 years
BMI 18.00-40.0 kg/m\^2
Able to understand the research and willing to sign a written informed consent document Cohort 2: (complete)
Age 18-40 years
BMI 18.00-40.0 kg/m\^2
Able to understand the research and willing to sign a written informed consent document Cohort 3:
Age 18-40 years
BMI 25.0-50.0 kg/m\^2 or BMI \> 18.5 kg/m\^2 with PCOS diagnosis
Diagnosis of PCOS based on NIH Criteria; defined by the presence of both clinical and/or biochemical signs of hyperandrogenism and oligo- or chronic anovulation.
Women of childbearing potential must agree to use a highly effective method of birth control, confirmed by the Investigator, for at least 3 months prior to the first study visit and continuing throughout the study duration. a. Highly effective methods of birth control include: i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable iii. Intrauterine device iv. Intrauterine hormone-releasing system v. Bilateral tubal occlusion vi. Sexual abstinence, i.e., refraining from heterosexual intercourse (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant) vii. Vasectomized sexual partner (provided that partner is the sole sexual partner of the study participant and that the vasectomized partner has received medical assessment of the surgical success) b. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for \>=12 months prior to the planned date of enrollment without an alternative medical cause.
Insulin resistance defined by either
HOMA-IR score \> 5.9 OR
HOMA-IR score \> 2.8 and \<5.9, with HDL \<51 mg/dL OR
Fasting Insulin \> 10.6 microU/mL
Able to understand the research and willing to sign a written informed consent document

Exclusion Criteria

Hypersensitivity and associated allergic reactions to mirabegron (or similar drug substances or components)
Abnormal bladder function, diagnosis of bladder outlet obstruction, urinary incontinence, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)
Type 1 or Type 2 Diabetes mellitus, fasting serum glucose \>125 mg/dL, and/or an HbA1c test \>6.5%
Hypertension, defined as blood pressure (Bullet)140/90 mmHg, based on WHO guidelines (https://www.who.int/news-room/fact-sheets/detail/hypertension)
Hypo- or hyper-thyroid disease (TSH \>5.0, \<0.4 miU/L) that is controlled for less than one year
Anemia, defined by hemoglobin \< 11.3 g/dL (females) or \< 13.8 g/dL (males); sickle cell anemia or other blood disorders; and/or wound healing problems
Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment
A clinically significant abnormal ECG and/or QTc interval above normal
Elevated liver enzymes with probable or diagnosed liver disease (other than fatty liver disease)
Psychological conditions such as claustrophobia, untreated clinical depression or anxiety, untreated bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study
Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics
Self-reported intolerance of cold that would prevent the individual from spending several hours in a chilled room with a cooling vest
Current use of any drugs known to:
have major drug-drug interactions with mirabegron
Prolong QT interval
Alter glucose metabolism or cause insulin resistance (in last six months)
Treat diabetes mellitus
Treat hypertension
Be drugs of abuse
Self-reported weight loss or weight gain \> 5% in the preceding 6 months.
Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months
Individuals who spend \>70% of daily hours outdoors since the exposure to varied environmental temperatures will potentially impact the ability to influence and measure BAT activity.
Addiction to alcohol or substances of abuse within the last 5 years
Self-reported current alcohol consumption of more than 2 servings of alcohol per day
Self-reported current use of nicotine and/or tobacco products
Has participated in a clinical trial with an investigational or marketed drug within 2 months
Have had previous radiation exposure (X-rays, PET scans, etc.) within the last year or anticipate radiation exposure in the upcoming year - clinical and/or research - that would exceed research limits
Donated blood within last 2 months
Unwilling or unable to eat metabolic meals, as determined by dietitian consult.
Any other circumstances or criteria that would preclude safe participation in the study in the clinical judgment of the investigator

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT03049462) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Polycystic Ovary Syndrome Treatment Options in Bethesda, MD

If you're searching for polycystic ovary syndrome treatment options in Bethesda, MD, this clinical trial (NCT03049462) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced polycystic ovary syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all polycystic ovary syndrome clinical trials near you to find additional studies recruiting in your area.

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