Dopamine and Insulin Resistance - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00802204

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); however approximately 10% of obese adults are metabolically healthy and do not have insulin resistance. We propose that insulin resistance contributes to low dopamine type 2 receptors and, using PET imaging, aim to determine if DRD2 binding in the brain and insulin resistance correlate.

Condition	Intervention
Obesity Post-Menopause	Radiation: PET scan Procedure: Oral glucose tolerance test Procedure: MRI Procedure: Muscle/fat biopsy Behavioral: Psychological scales to assess attitudes and behaviors related to eating and quality of life

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Dopamine and Insulin Resistance

Resource links provided by NLM:

MedlinePlus related topics: Menopause Nuclear Scans Obesity

Drug Information available for: Dopamine Dopamine hydrochloride Insulin Dextrose

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Does insulin sensitivity correlate with DRD2 receptor binding? [ Time Frame: Day of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Serum, plasma, tissues

Estimated Enrollment:	28
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Obese, post-menopausal females Obese postmenopausal females with varying degrees of insulin sensitivity	Radiation: PET scan Subjects will undergo a PET scan of the brain using the radioligand,fallypride [18F]. 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 will be performed prior to scheduling PET scan Procedure: Muscle/fat biopsy A punch biopsy will be performed on the upper thigh in order to obtain fat and muscle tissues 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.

Groups/Cohorts

Assigned Interventions

Obese, post-menopausal females

Obese postmenopausal females with varying degrees of insulin sensitivity

Radiation: PET scan

Subjects will undergo a PET scan of the brain using the radioligand,fallypride [18F].

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 will be performed prior to scheduling PET scan

Procedure: Muscle/fat biopsy

A punch biopsy will be performed on the upper thigh in order to obtain fat and muscle tissues

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.

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Post-menopausal, obese females

Criteria

Inclusion Criteria:

Post-menopausal females ages 40-60 yrs
BMI 30-40kg/m2
Weight less than 350 lbs

Exclusion Criteria:

On estrogen (herbal or medical)therapy
Structured exercise more than 2 times a week
Diagnosis of diabetes
History of Substance Abuse, including but exclusive to alcohol, cocaine, marijuana, heroin, nicotine
History of psychiatric disorder
Use or any antidepressants or antipsychotics for 8 weeks 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

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

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

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

Responsible Party:	Vanderbilt University Medical Center ( Julia Dunn, MD )
Study ID Numbers:	IRB#080861
Study First Received:	December 2, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00802204 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt University:

Obesity
Post-menopause
Female
Insulin Resistance

Additional relevant MeSH terms:

Obesity
Metabolic Diseases
Physiological Effects of Drugs
Overweight
Pharmacologic Actions
Insulin
Body Weight

Hyperinsulinism
Signs and Symptoms
Hypoglycemic Agents
Nutrition Disorders
Overnutrition
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010