N/A
N=28
Dopamine and Insulin Resistance
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00802204 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Striatal DRD2 Receptor Binding — 28; 33; 32; 33 ratio — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PET scan (Radiation); Oral glucose tolerance test (Procedure); MRI (Procedure); Psychological scales to assess attitudes and behaviors related to eating and quality of life (Behavioral); Caloric Restriction (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Striatal DRD2 Receptor Binding |
28; 33; 32; 33; 38; 36 | <0.05 sig |
| PRIMARY Insulin |
6; 19; 11 | — |
| PRIMARY Glucose |
82; 87; 81 | — |
| PRIMARY Leptin |
13; 43; 34 | — |
| PRIMARY Acyl Ghrelin |
235; 78; 59 | — |
| PRIMARY Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI) |
11; 4; 4 | — |
| SECONDARY Binge Eating Score Questionnaire |
6; 12 | — |
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
Eligibility Criteria
Inclusion Criteria
- Ages 18-60 yrs
- obese BMI > 30kg/m2 and Weight less than 350 lbs
- lean control BMI 18-25kg/m2
Exclusion Criteria
- Structured exercise > equivalent to 30mins 5x week of walking times a week
- History of Substance Abuse, including but exclusive to alcohol, cocaine, marijuana, heroin, nicotine
- Current psychiatric disorder or significant h/o disorder
- Use or any antidepressants or antipsychotics for last 3-6months or depot antipsychotics in the last 12 months
- Any condition felt by PI or co-investigators to interfere with ability to complete the study
- Inability to abstain from alcohol, physical exercise or > 1 cup of coffee or equivalent daily for 3 days prior to imaging studies
- Significant co-morbidities including atherosclerotic disease, metabolic disease, liver or renal insufficiency or abnormality found on MRI
- Any condition which would interfere with MRI or PET studies, e.g. claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body which may interfere with MRI scanning
- Subjects on medications determined by PI, ex. sibutramine, frequent benzodiazepines or related drugs, which could affect quality of study for last 3 months.
Data sourced from ClinicalTrials.gov (NCT00802204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.