Trial · NCT01950520
Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
NCT01950520, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2024-10-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate. Trials, record NCT01950520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01950520
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate
- NCT number
- NCT01950520
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Healthy Volunteers
- Interventions
Propranolol, Pindolol, Dantrolene, Magnesium Sulfate, Caffeine, Qsymia, Topiramate, Phentermine, Naltrexone, Mirabegron 50mg, Mirabegron 200mg, Placebo Cohort 1, Placebo Cohort 2, Placebo for Mirabegron
- First posted
- 2013-09-25
- Last updated
- 2024-10-16
- Results first posted
- 2024-10-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Resting Energy Expenditure at Low Temperature | Cohort 1: Days 1-17 | Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold. |
| Primary | Resting Energy Expenditure at Low Temperature | Cohorts 2: Six one-day overnight inpatient stays over a six to twelve week period. | Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold. |
| Primary | Resting Energy Expenditure at Low Temperature | Cohort 3: Four one-day overnight inpatient stays over a 12-week period. | Resting energy expenditure (REE) at a temperature just above the subject's placebo shivering threshold. |
| Primary | Basal Metabolic Rate | Cohort 1: Days 1-17 | Basal metabolic rate (BMR) is the resting energy expenditure (REE) at thermoneutrality (27c). |
| Primary | Brown Adipose Tissue Activity (Cohort 3 Only) | Cohort 3: Four one-day overnight inpatient stays over a 12-week period. | Brown adipose tissue (BAT) activity is a quantification of tissue volume and metabolic activity per unit volume. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Resting Energy Expenditure at Low Temperature | Cohort 1: Days 1-17 | Cohort 1 | kcal/min | MEAN |
| PRIMARY | Resting Energy Expenditure at Low Temperature | Cohorts 2: Six one-day overnight inpatient stays over a six to twelve week period. | missed visits due to Covid etc. | kcal/min | MEAN |
| PRIMARY | Resting Energy Expenditure at Low Temperature | Cohort 3: Four one-day overnight inpatient stays over a 12-week period. | missed visits due to Covid etc. | kcal/min | MEAN |
| PRIMARY | Basal Metabolic Rate | Cohort 1: Days 1-17 | Cohort 1 | kcal/min | MEAN |
| PRIMARY | Brown Adipose Tissue Activity (Cohort 3 Only) | Cohort 3: Four one-day overnight inpatient stays over a 12-week period. | missed visits due to Covid etc. | mL*SUVmean*g/mL | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Resting Energy Expenditure at Low Temperature | Cohort 1 | Placebo Cohort 1 | 1.277 | Standard Deviation 0.151 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 1 | Propranolol | 1.134 | Standard Deviation 0.109 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 1 | Dantrolene | 1.300 | Standard Deviation 0.118 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 1 | Magnesium sulfate | 1.271 | Standard Deviation 0.126 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 1 | Pindolol | 1.165 | Standard Deviation 0.112 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 2 | Caffeine | 1.292 | Standard Deviation 0.123 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 2 | Phentermine | 1.217 | Standard Deviation 0.116 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 2 | Topiramate | 1.191 | Standard Deviation 0.122 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 2 | Qsymia | 1.228 | Standard Deviation 0.122 | kcal/min |
| Resting Energy Expenditure at Low Temperature | Cohort 2 | Naltrexone | 1.185 | Standard Deviation 0.140 | kcal/min |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 16 | |
| Overall Study | STARTED | Cohort 2 | 18 | |
| Overall Study | STARTED | Cohort 3 | 13 | |
| Overall Study | COMPLETED | Cohort 1 | 16 | |
| Overall Study | COMPLETED | Cohort 2 | 17 | |
| Overall Study | COMPLETED | Cohort 3 | 12 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 1 | |
| Overall Study | NOT COMPLETED | Cohort 3 | 1 |
Source ClinicalTrials.gov
Adverse events247
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 Low Temperature : Placebo | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 Low Temperature : Proprannolol | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 Low Temperature : Dantrolene | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 Low Temperature : Magnesium | 1 | 16 | 1 |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 Low Temperature : Pindolol | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 High Temperature : Placebo | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 High Temperature : Proprannolol | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 High Temperature : Dantrolene | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 High Temperature : Magnesium | 0 | 16 | |
| other | Asymptomatic non-sustained ventricular tachycardia | Cardiac disorders | Cohort 1 High Temperature : Pindolol | 0 | 16 |
1 to 10 of 247Source ClinicalTrials.gov
See all 247 adverse eventsAdverse event totals57
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Low Temperature : Placebo | 0 | 16 |
| Total, all-cause mortality | Cohort 1 Low Temperature : Proprannolol | 0 | 16 |
| Total, all-cause mortality | Cohort 1 Low Temperature : Dantrolene | 0 | 16 |
| Total, all-cause mortality | Cohort 1 Low Temperature : Magnesium | 0 | 16 |
| Total, all-cause mortality | Cohort 1 Low Temperature : Pindolol | 0 | 16 |
| Total, all-cause mortality | Cohort 1 High Temperature : Placebo | 0 | 16 |
| Total, all-cause mortality | Cohort 1 High Temperature : Proprannolol | 0 | 16 |
| Total, all-cause mortality | Cohort 1 High Temperature : Dantrolene | 0 | 16 |
| Total, all-cause mortality | Cohort 1 High Temperature : Magnesium | 0 | 16 |
| Total, all-cause mortality | Cohort 1 High Temperature : Pindolol | 0 | 16 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01950520
GET https://conductscience.org/api/trials/v1/NCT01950520/results?page=2