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).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:

MedlinePlus related topics: Diabetes Medicines Nuclear Scans Obesity

Drug Information available for: Dopamine Dopamine hydrochloride Insulin Insulin beef Dextrose

U.S. FDA Resources

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

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

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

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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Dopamine
Dopamine Agents
Insulin

Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on February 09, 2012