Dopamine and Insulin Resistance - Tabular View

Tracking Information

First Received Date ^ICMJE

December 2, 2008

Last Updated Date

August 11, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00802204 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dopamine and Insulin Resistance

Official Title ^ICMJE

Dopamine and Insulin Resistance

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Obesity
Post-Menopause

Intervention ^ICMJE

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 Arms / Comparison Groups

Obese postmenopausal females with varying degrees of insulin sensitivity

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00802204

Responsible Party

Julia Dunn, MD, Vanderbilt University Medical Center

Study ID Numbers ^ICMJE

IRB#080861

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Julia P Dunn, MD	Vanderbilt University
Study Director:	Robert M Kessler, MD	Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

August 2009

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