CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
PET scan +4 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00802204
NCT00802204N/ACompleted

Dopamine Receptor Availability and Insulin Resistance

Vanderbilt University·interventional·Posted Dec 4, 2008·Updated May 10, 2017

In Brief

A clinical study evaluating PET scan, Oral glucose tolerance test, and 3 other interventions for Obesity. Completed, enrolled 28 participants across 1 site.

Detailed Summary

Obese individuals have fewer striatal dopamine type 2 receptors (DRD2) than normal weight individuals. Lower DRD2 levels are associated with addiction and a decreased sense of pleasure.Obesity is also associated with insulin resistance (poor insulin action).We propose that insulin resistance and low DRD2 are associated. Using PET imaging,we aim to determine DRD2 binding potential (BP) in the brain is associated with insulin resistance and neuroendocrine hormone levels. Obese participants will be compared to lean, gender and age similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP in obese subjects

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 4, 2008
Enrollment StartDec 1, 2008
Primary CompletionApr 1, 2011
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.6 years ago

Interventions

PET scanradiation

Both lean and obese undergo a PET scan of the brain using the radioligand,fallypride \[18F\] at baseline. Obese subjects who complete caloric restriction will have repeat scan after diet. Completed at baseline and post-VLCD

Oral glucose tolerance testprocedure

Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period Completed at baseline by both lean and obese and in obese post-VLCD

MRIprocedure

An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese

Psychological scales to assess attitudes and behaviors related to eating and quality of lifebehavioral

A series of short psychological scales will be administered during the study. Completed at baseline

Caloric Restrictionother

Obese participants only complete a short-term (\~10days) very low calorie diet