Changes in Ectopic Fat Following Surgically Induced Weight Loss
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00840307|
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : November 20, 2017
Last Update Posted : December 13, 2017
|Condition or disease|
|Obesity Type 2 Diabetes|
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:
- MRS 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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- Pancreatic and Liver Triglyceride (Fat) Content [ Time Frame: months after the first band inflation ]Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|