RecruitingPhase 1Drug trial
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists
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.
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