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NCT01950520 · ClinicalTrials.gov registry record · Phase 2
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
A Phase 2 study of Healthy Volunteers, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 1
- Study location
NCT01950520 is a Phase 2 study of Healthy Volunteers that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 47 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01950520, a Phase 2 study of Healthy Volunteers, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- DRUG Dantrolene
- DRUG Magnesium Sulfate
- DRUG Propranolol
- DRUG Caffeine
- DRUG Pindolol
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2014-02-07 |
| Est. Completion | 2024-06-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01950520
The ClinicalTrials.gov registry entry for NCT01950520 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (90% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Dantrolene is the first listed.
NCT01950520 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01950520 about?
NCT01950520 is a clinical study titled "Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate". 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 thermogenes...
What is the current status of trial NCT01950520?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2014-02-07. Estimated completion is 2024-06-11.
What conditions does trial NCT01950520 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01950520?
The interventions under investigation include: Dantrolene (DRUG), Magnesium Sulfate (DRUG), Propranolol (DRUG), Caffeine (DRUG), Pindolol (DRUG).
Who is sponsoring clinical trial NCT01950520?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01950520 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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