Changes in Ectopic Fat Following Surgically Induced Weight Loss

This study is currently recruiting participants.

Verified by University of Texas Southwestern Medical Center, August 2009

First Received: February 6, 2009 Last Updated: August 11, 2009 History of Changes

Sponsor:	University of Texas Southwestern Medical Center
Collaborator:	National Institutes of Health (NIH)
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00840307

Purpose

This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function.

Condition
Obesity Type 2 Diabetes

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity Surgery Weight Control

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients already scheduled to undergo gastric banding within 1-2 months.

This study does NOT pay for the bariatric surgery, eligible participants must already be scheduled to have the surgery performed by their own physician

Criteria

Inclusion Criteria:

Greater than 18 years old
Fully understanding and willing to undergo study procedures
Available for follow-up
Understand and willing to sign informed consent
Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study

Exclusion Criteria:

Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
History of pancreatic disease other than diabetes
Regular use of more than 2 alcoholic drinks per day
Pregnancy
Non-English speaking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840307

Contacts

Contact: Laura Golici, BA	214-648-2515	ResearchProgram@UTSouthwestern.edu
Contact: Ildiko Lingvay, MD, MPH	214-648-2779	ildiko.lingvay@utsouthwestern.edu

Locations

United States, Texas
University of Texas Southwestern	Recruiting
Dallas, Texas, United States, 75390
Contact: Laura Golici, BA 214-648-2515 ResearchProgram@UTSouthwestern.edu
Contact: Ildiko Lingvay, MD, MPH 214-648-2779 ildiko.lingvay@utsouthwestern.edu
Principal Investigator: Ildiko Lingvay, MD, MPH

Sponsors and Collaborators

University of Texas Southwestern Medical Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Ildiko Lingvay, MD, MPH

University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	University of Texas Southwestern Medical Center ( Ildiko Lingvay, MD, MPH )
Study ID Numbers:	072008-039, NIH Grant: 1K23RR024470-01
Study First Received:	February 6, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00840307 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:

Obesity
Type 2 Diabetes
Gastric Banding

Additional relevant MeSH terms:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Diabetes Mellitus, Type 2
Weight Loss
Body Weight Changes
Nutrition Disorders
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010