Dopamine and Insulin Resistance
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: 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)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Julia P Dunn, MD, Principal Investigator, Affiliation: Vanderbilt University Robert M Kessler, MD, Study Director, Affiliation: Vanderbilt University
Overall contact: Pamela A Marks, MS, RD, Phone: 615-343-8389, Email: pamela.a.marks@vanderbilt.edu
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
Clinical Details
Official title: Dopamine and Insulin Resistance
Study design: Intervention Model: Single Group Assignment, Masking: Open Label
Primary outcome: Are fasting neuroendocrine hormones and insulin sensitivity associated with DRD2 receptor binding?
Secondary outcome: Are certain eating behaviors associated with DRD2 binding?Does caloric restriction alter DRD2 DP in obese participants?
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Pamela A Marks, MS, RD, Phone: 615-343-8389, Email: pamela.a.marks@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting Marks, Email: obesityresearch@vanderbilt.edu Julia P Dunn, MD, Principal Investigator
Additional Information
Starting date: December 2008
Last updated: February 14, 2011
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