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Dopamine and Insulin Resistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julia P.Dunn,MD, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00802204
First received: December 2, 2008
Last updated: December 12, 2015
Last verified: February 2011

December 2, 2008
December 12, 2015
December 2008
April 2011   (final data collection date for primary outcome measure)
Are fasting neuroendocrine hormones and insulin sensitivity associated with DRD2 receptor binding? [ Time Frame: Day of study ] [ Designated as safety issue: No ]
Does insulin sensitivity correlate with DRD2 receptor binding? [ Time Frame: Day of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00802204 on ClinicalTrials.gov Archive Site
  • Are certain eating behaviors associated with DRD2 binding? [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Does caloric restriction alter DRD2 DP in obese participants? [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Do adipokine levels correlate with DRD2 binding? [ Time Frame: Day of study ] [ Designated as safety issue: No ]
  • Are there psychological differences between metabolically healthy individuals and insulin resistant individuals? [ Time Frame: Day of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Dopamine and Insulin Resistance
Dopamine and Insulin Resistance
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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Obesity
  • Radiation: PET scan
    Subjects will undergo a PET scan of the brain using the radioligand,fallypride [18F]. Obese subjects who complete caloric restriction will have repeat scan after diet.
  • Procedure: Oral glucose tolerance test
    Subjects will be required to drink a glucose solution; blood samples will be taken over a 5-hour time period
  • Procedure: MRI
    An MRI of the brain and abdomen will be performed prior to PET scan
  • Behavioral: Psychological scales to assess attitudes and behaviors related to eating and quality of life
    A series of short psychological scales will be administered during the study.
  • Other: Caloric Restriction
    Obese participants will go a shortterm very low calorie diet
Experimental: Obese and lean controls
Obese participants and age and gender similar lean controls
Interventions:
  • Radiation: PET scan
  • Procedure: Oral glucose tolerance test
  • Procedure: MRI
  • Behavioral: Psychological scales to assess attitudes and behaviors related to eating and quality of life
  • Other: Caloric Restriction

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2012
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00802204
IRB#080861 and 061246
No
Not Provided
Not Provided
Julia P.Dunn,MD, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Julia P Dunn, MD Vanderbilt University
Study Director: Robert M Kessler, MD Vanderbilt University
Vanderbilt University
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP