The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta… (NCT03049462) | Clinical Trial Compass
RecruitingPhase 1
The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists
United States100 participantsStarted 2017-03-13
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
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)
✕
What they're measuring
1
Cohorts 1 and 2: Change in BAT metabolic activity
Timeframe: 4 weeks
2
Cohort 3: Change in insulin sensitivity
Timeframe: 4 weeks
Trial details
NCT IDNCT03049462
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
. 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