RecruitingPhase 1NCT03049462

The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists

Sponsor

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

Enrollment

100 participants

Start Date

Mar 13, 2017

Study Type

INTERVENTIONAL

Conditions

Polycystic Ovary Syndrome

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how a bladder medication (mirabegron) activates "brown fat" — a special type of body fat that burns calories — and whether this can help treat hormonal and metabolic problems in women with Polycystic Ovary Syndrome (PCOS) and insulin resistance. **You may be eligible if...** - You are a woman between 18 and 40 years old - You have a BMI between 25 and 50 kg/m², OR a BMI above 18.5 with a PCOS diagnosis - You have PCOS (diagnosed by irregular periods and/or excess male hormones) - You have insulin resistance (your body does not respond well to insulin), confirmed by a blood test - You have not been diagnosed with type 1 or type 2 diabetes - You agree to use reliable contraception throughout the study **You may NOT be eligible if...** - You have type 1 or type 2 diabetes, or high fasting blood sugar - You have high blood pressure, heart disease, or a serious heart rhythm problem - You have thyroid disease that is not well-controlled for at least one year - You are pregnant, breastfeeding, or gave birth within the past year - You currently smoke or use nicotine products - You drink more than 2 alcoholic drinks per day - You take medications that interact with mirabegron, affect blood sugar, or alter blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMirabegron

Women will take 100mg daily for 4 weeks. Men will take 200mg daily for 4 weeks. The medication is available in 50 mg tablets.

OTHERB Complex Plus Vitamin C Tablets

Males will be randomized to take placebo versus active drug (mirabegron). Those taking placebo will take 4 tablets each day to mirror to active group (taking 4 tablets of 50 mg each).