Dopamine and Insulin Resistance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00802204
First received: December 2, 2008
Last updated: February 14, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Obesity
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Dopamine and Insulin Resistance

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Are fasting neuroendocrine hormones and insulin sensitivity associated with DRD2 receptor binding? [ Time Frame: Day of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese and lean controls
Obese participants and age and gender similar lean controls
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802204

Contacts
Contact: Pamela A Marks, MS, RD 615-343-8389 pamela.a.marks@vanderbilt.edu
Contact: Julia P Dunn, MD 615-322-3957 obesityresearch@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Marks       obesityresearch@vanderbilt.edu   
Principal Investigator: Julia P Dunn, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Julia P Dunn, MD Vanderbilt University
Study Director: Robert M Kessler, MD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Julia Dunn, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00802204     History of Changes
Other Study ID Numbers: IRB#080861 and 061246
Study First Received: December 2, 2008
Last Updated: February 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Obesity
Insulin Resistance
Neuroendocrine regulation
Eating behaviors
Dopamine signaling

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Body Weight
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Dopamine
Dopamine Agents
Insulin
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014