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NCT02063451 · ClinicalTrials.gov registry record · NA
Neurohormonal & Behavioral Correlates of Obesity and Weight Loss
A NA study of Obesity, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02063451 is a NA study of Obesity that has completed, run by University of Michigan. The registered enrollment target is 16 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02063451, a NA study of Obesity, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Obesity has reached epidemic levels in the United States, and is on the rise in many industrialized nations. The rate of recidivism for long-term weight loss is substantial and presents a critical problem given the importance of obesity as a modifiable risk factor for diseases like type 2 diabetes. Further, the comorbidity of depression with diseases like obesity, type 2 diabetes, and cardiovascular disease suggest that there may be an underlying shared biology for diseases of metabolic dysfunction and emotional dysregulation. The shared biology of these diseases may actually promote the precipitation and exacerbation of comorbid conditions, impacting the success of treatment. Endogenous opioid systems regulate a number of physiological and psychological processes including mood, energy management, and reward. Endogenous opioid µ-receptor-mediated reward processing is thought to be involved both in the short-term control of eating and hedonic food consumption, based on data in animal models. The present proposal will examine the function of the µ-opioid receptor (MOR) system in lean and obese human volunteers following an overnight fast and the change in µ-opioid receptor occupancy (i.e., endogenous opioid release) following the consumption of a standardized meal using PET imaging with the µ-selective radiotracer \[11C\]carfentanil. The obese individuals will be retested in the fasting and fed state following a 15% weight loss with a Very Low Calorie Diet. Further, the investigators will evaluate the function of the MOR system within the context of the individual's metabolic and psychological profile including aspects of mood and inhibitory control. This information will provide the neurobiological bases to develop novel avenues of intervention based on individual variations in central mechanisms associated with motivational systems and appetite and their potential role in weight regain. The investigators hypothesize that overeating in chronically obese individuals
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Very Low Calorie Diet (VLCD)
Study Locations (1)
Michigan
- University of Michigan Medical School - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-01-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02063451
The ClinicalTrials.gov registry entry for NCT02063451 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Very Low Calorie Diet (VLCD) is the first listed.
NCT02063451 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT02063451 about?
NCT02063451 is a clinical study titled "Neurohormonal & Behavioral Correlates of Obesity and Weight Loss". Obesity has reached epidemic levels in the United States, and is on the rise in many industrialized nations. The rate of recidivism for long-term weight loss is substantial and presents a critical problem given the importance of obesity as a modifiable risk factor for diseases like type 2 diabetes. ...
What is the current status of trial NCT02063451?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2011-02. Estimated completion is 2013-01-15.
What conditions does trial NCT02063451 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT02063451?
The interventions under investigation include: Very Low Calorie Diet (VLCD) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02063451?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02063451 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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