BridgeMD
New treatment option for Polycystic Ovary Syndrome
Official title The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists
ClinicalTrials.gov ID: NCT03049462
What this study is testing
What is Mirabegron?
Mirabegron is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for polycystic ovary syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Cohort 1: (complete)
- Female
- 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)
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Cohort 1: (complete)
- Female
- 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)
- Male
- 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:
- Female
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.