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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: March 29, 2017
Last verified: March 2017
December 2, 2008
March 29, 2017
December 2008
April 2011   (Final data collection date for primary outcome measure)
  • Striatal DRD2 Receptor Binding [ Time Frame: Baseline and after 8-10days VLCD ]
    Region of interest compared to reference region to calculate binding potential
  • Insulin [ Time Frame: Baseline to post 8-10days after VLCD ]
    microU/ml
  • Glucose [ Time Frame: Baseline to post 8-10days after VLCD ]
  • Leptin [ Time Frame: Baseline to post 8-10days after VLCD ]
  • Acyl Ghrelin [ Time Frame: Baseline to post 8-10days after VLCD ]
  • Insulin Sensitivity From Oral Glucose Tolerance Test (OGTT_SI) [ Time Frame: Baseline to post 8-10days after VLCD ]
    Insulin Sensitivity from Oral Glucose Tolerance Test was estimated using the minimal model method
Does insulin sensitivity correlate with DRD2 receptor binding? [ Time Frame: Day of study ]
Complete list of historical versions of study NCT00802204 on ClinicalTrials.gov Archive Site
Binge Eating Score Questionnaire [ Time Frame: Baseline ]
Increased scores indicate increased binge eating behaviors. Score 0-46
  • Do adipokine levels correlate with DRD2 binding? [ Time Frame: Day of study ]
  • Are there psychological differences between metabolically healthy individuals and insulin resistant individuals? [ Time Frame: Day of study ]
Not Provided
Not Provided
 
Dopamine and Insulin Resistance
Dopamine Receptor Availability 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
In has been reported obese individuals have fewer striatal dopamine type 2 receptors (DRD2) compared to normal weight individuals congruent with diet induced obese rodent models and similar to models of addiction. Lower DRD2 levels are associated with addiction and a decreased sense of pleasure. Excessive weight gain also contributes to the onset of impaired insulin signaling (insulin resistance). In the brain insulin regulates monoamines and has trophic effects. We propose that the previous reports of low DRD2 in individuals with obesity will be associated with the degree of insulin resistance. Using PET imaging, we aim to determine DRD2 binding potential (BP) in the striatum and hypothesize these measurements will be associated with insulin resistance and potentially other neuroendocrine hormone levels. Obese participants will be compared to lean, sex and age similar participants. We also aim to determine the effect of caloric restriction on DRD2 BP in obese subjects. We hypothesize the caloric restriction will improve insulin resistance and that changes in DRD2 binding will be associated with changes in insulin signaling.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Lean who are age and sex similar to obese will complete baseline outcome measurements only.

Obese will complete baseline outcome measurements then the VLCD intervention with post outcome measurements .

Masking: No masking
Primary Purpose: Other
Obesity
  • Radiation: PET scan

    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

  • 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 Completed at baseline by both lean and obese and in obese post-VLCD
  • Procedure: MRI
    An MRI of the brain and abdomen will be performed prior to PET scan One time at baseline in both lean and obese
  • 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. Completed at baseline
  • Other: Caloric Restriction
    Obese participants only complete a short-term (~10days) very low calorie diet
  • Active Comparator: Lean controls
    Lean complete baseline outcome measures only
    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
  • Experimental: Obese
    Obese completing baseline and post-VLCD outcome measures
    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
28
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.
Sexes Eligible for Study: All
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
Not Provided
Julia P.Dunn,MD, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Julia P Dunn, MD Vanderbilt University Medical Center
Study Director: Robert M Kessler, MD Vanderbilt University Medical Center
Vanderbilt University Medical Center
March 2017

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