drugset / Trial / NCT01950520

Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

NCT01950520

RandomizedCrossoverDouble-blindBasic science

Summary

Background: \- Changes in how a person's body burns energy or calories can affect their weight over time. The lowest level of energy the body needs to function is called basal metabolic rate. In the cold, we burn extra energy, even before we start to shiver. This is called non-shivering thermogenesis and it occurs in different types of tissue such as muscle and fat. Researchers want to learn more about this type of energy burning and how it is regulated. They hope this will help treat obesity in the future. Objectives: * Sub-study 1: to better understand how non-shivering thermogenesis works. * Sub-study 2: to measure the effects of anti-obesity drugs on basal metabolic rate. * Sub-study 3: to better understand the effects of mirabegron, a beta-3 adrenergic receptor agonist, on brown fat activity. Eligibility: \- Healthy, lean adult males ages 18 to 35. Design: * Participants will be screened with medical history, physical exam, blood test, and EKG. * For sub-studies 1 and 2: * Participants will receive one X-ray scan. * Each day, all participants will: * Have height and weight measured, and have urine collected. * Spend 4 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering. * Walk for 30 minutes. * For sub-study 3: * Participants will receive one DXA scan and up to 4 PET/CT scans and 4 MRIs * Each stay, all participants will: * Have height and weight measured, and have urine collected. * Spend 6 hours in a temperature-controlled room with furniture, toilet area, phone, and computer. They will wear small non-invasive devices to monitor activity, heart rate, temperature, and shivering. * Participants will be compensated for their time and participation at the end of the study

Timeline

Start
2014-02-07
Primary completion
2022-12-17
Completion
2024-06-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Caffeine Small molecule 200 mg Oral
Subject Dantrolene Small molecule 100 mg Oral
Subject Magnesium Sulfate Other / unclassified 2 g Other
Subject Mirabegron Other / unclassified 50 mg Oral
Subject Mirabegron Other / unclassified 200 mg Oral
Subject Naltrexone Small molecule 100 mg Oral
Subject Phentermine Small molecule 15 mg Oral
Subject Phentermine Small molecule 37.5 mg Oral
Subject Pindolol Small molecule 20 mg Oral
Subject Propranolol Small molecule 160 mg Oral
Subject Topiramate Small molecule 92 mg Oral
Subject Topiramate Small molecule 200 mg Oral

Indications

No indication recorded.