Changes in Ectopic Fat Following Surgically Induced Weight Loss
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.
Type 2 Diabetes
|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?|
- 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).
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||May 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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:
- MRI to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840307
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Ildiko Lingvay, MD, MPH||University of Texas Southwestern Medical Center|