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Changes in Ectopic Fat Following Surgically Induced Weight Loss

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Ildiko Lingvay, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00840307
First received: February 6, 2009
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  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: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Association between pancreatic triglyceride and beta cell function [ Time Frame: December/2012 ] [ Designated as safety issue: No ]
    To evaluate the association between pancreatic triglyceride (TG) content measured by the magnetic resonance spectroscopy (MRS) technique and beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).


Estimated Enrollment: 20
Study Start Date: August 2008
Estimated Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

We are looking for volunteers for this study,wich involves 7 visits over a period of 13 months, the first visit taking place about 2 weeks prior to the planned surgery.

Visit 1 - baseline, before starting your pre-operative diet Visit 2 - just before the surgery Visit 3 - around the time your first band inflation occurs Visit 4 - 1 month after the band inflation Visit 5 - 3 months after the first band inflation Visit 6 - 6 months after the first band inflation Visit 7 - 12 months after the first band inflation

At each visit we do the following tests:

  1. MRI to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
  2. Frequently sampled intravenous glucose tolerance test - it is a 3.5 hrs test which determines the amount of insulin your body produces and how well your own insulin is being used by the body
  3. Body measurements (waist, hip circumference), cholesterol panel, liver function tests, HbA1c (to monitor diabetes control), blood pressure, weight.

We also do an oral glucose tolerance test to check for diabetes on 3 occasions: visit 1, visit 5 and at the end, visit 7.

  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

Locations
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
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: Ildiko Lingvay, MD, MPH, MSCS, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00840307     History of Changes
Other Study ID Numbers: 072008-039, NIH Grant: 1K23RR024470-01
Study First Received: February 6, 2009
Last Updated: January 22, 2013
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 16, 2013