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NCT01791114 · ClinicalTrials.gov registry record · NA
The Effect of Brown Adipose Tissue Activation on Insulin Sensitivity in Humans
A NA study, sponsored by Rutgers University.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT01791114 is a NA study that has completed, run by Rutgers University. The registered enrollment target is 39 participants.
The verdict
NCT01791114, a NA study, has completed, sponsored by Rutgers University.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
Recent findings document the presence of active brown adipose tissue (BAT) in humans. Cold exposure via adrenergic stimulation activates BAT, which combusts significant amounts of blood glucose and free fatty acid (FFA) to produce heat. Animal studies suggest that BAT activation improves insulin sensitivity. However, the effect of cold-induced BAT activation on insulin sensitivity and glucose kinetics in humans remains unknown. The investigators' central hypothesis is that cold-induced BAT activation increases whole body insulin sensitivity in humans via augmented plasma glucose and FFA clearance. The specific aims of this study are to define the effects of prolonged (8h) cold exposure BAT activation on: insulin sensitivity (Aim 1); lipolysis and plasma glucose and FFA kinetics (Aim 2); on thermoregulation (Aim 3). Moreover, the investigators plan to investigate for alternative ways, which can activate BAT including cold water ingestion, a single meal ingestion, and a single bout of moderate intensity exercise (Aim 4). For the cold exposure study, subjects will complete 3 trials: a) 8hrs of cold exposure at their individually determined shivering threshold; b) 8hrs of cold exposure at their individually determined shivering threshold plus propranolol; c) 8hrs in thermoneutral conditions (26 - 28°C). For the rest of the arms of subjects will complete two trials: cold or tepid water ingestion, a single meal ingestion or no food ingestion, and a single bout of moderate intensity exercise or no exercise.To study the above aims, the investigators will use positron emission tomography - computed tomography, hyperinsulinemic euglycemic clamp, infusion of stable isotopes, and tissue biopsies. The findings will illuminate the role of BAT on plasma substrate regulation and insulin sensitivity and may aid in the development of lifestyle recommendations and pharmacotherapy for the prevention and treatment of diabetes and insulin resistance.
Interventions
- OTHER Cold exposure
- OTHER Cold exposure plus propranolol
- OTHER Thermoneutral Conditions
- OTHER Cold water consumption
- OTHER Tepid water consumption
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2012-01 |
| Est. Completion | 2018-12-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01791114
The ClinicalTrials.gov registry entry for NCT01791114 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers University, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cold exposure is the first listed.
NCT01791114 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01791114 about?
NCT01791114 is a clinical study titled "The Effect of Brown Adipose Tissue Activation on Insulin Sensitivity in Humans". Recent findings document the presence of active brown adipose tissue (BAT) in humans. Cold exposure via adrenergic stimulation activates BAT, which combusts significant amounts of blood glucose and free fatty acid (FFA) to produce heat. Animal studies suggest that BAT activation improves insulin sen...
What is the current status of trial NCT01791114?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2012-01. Estimated completion is 2018-12-30.
What interventions are being tested in trial NCT01791114?
The interventions under investigation include: Cold exposure (OTHER), Cold exposure plus propranolol (OTHER), Thermoneutral Conditions (OTHER), Cold water consumption (OTHER), Tepid water consumption (OTHER).
Who is sponsoring clinical trial NCT01791114?
This trial is sponsored by Rutgers University, which has 18 total clinical trials registered on ClinicalTrials.gov.
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