Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
Public ClinicalTrials.gov record NCT01950520. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Mechanism of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01950520
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 47 participants
Conditions and interventions
Conditions
Interventions
- Propranolol Drug
- Pindolol Drug
- Dantrolene Drug
- Magnesium Sulfate Drug
- Caffeine Drug
- Qsymia Drug
- Topiramate Drug
- Phentermine Behavioral
- Naltrexone Drug
- Mirabegron 50mg Drug
- Mirabegron 200mg Drug
- Placebo Cohort 1 Drug
- Placebo Cohort 2 Drug
- Placebo for Mirabegron Drug
Drug · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 35 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2014
- Primary completion
- Dec 16, 2022
- Completion
- Jun 10, 2024
- Last update posted
- Oct 15, 2024
2014 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01950520, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01950520 live on ClinicalTrials.gov.