Diabetes and Gastric By- Pass
The purpose of this study is to evaluate the mechanisms leading to rapid postoperative improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and compare the changes in glucose level, beta-cell function, and insulin resistance induced by a week of very low calorie liquid diet and those induced by a week of matched very -low calorie liquid diet occuring in the context of routine postoperative care following RYGB.
Type 2 Diabetes
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery|
- Glucose area under the curve during Mixed Meal Challenge Test [ Time Frame: 9 days ] [ Designated as safety issue: No ]Will evaluate the change in the glucose AUC between the baseline evaluation (day 1) and the follow-up evaluation (day 9).
Biospecimen Retention: Samples Without DNA
whole blood samples, plasma, serum, urine,
|Study Start Date:||June 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Volunteers planned to undergo RYGB will be studied during two-9 days periods of identical and controlled diet and activity, separated by a 4-10-week washout period.
Study Period #1:
This first study period is 9 days/nights long and requires you to be closely supervised at our Clinical and Translational Research Center (CTRC). During this time you will receive the same diet and are expected to have the same activity level you will be prescribed in the immediate post-operative period.
During this study period you are expected to return to your usual diet and exercise level.
Study Period #2:
This last study period is also 9 days/nights long, includes the EXACT same diet you have received during the first study period, and in addition you will undergo the planned gastric by-pass surgery.
Procedures during the research:
Mixed Meal Challenge test will be done four times during the entire study: days 1 and 9 for each study period. This test allows the investigators to evaluate how much insulin your body is producing and how well this insulin is processed.
Measurement of resting energy expenditure will be done four times during the entire study. This test tell us how much energy your body is burning up in a resting state.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153516
|United States, Texas|
|Clinical and Translational Research Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Ildiko Lingvay, MD, MPH, MSCS||UT Southwestern Medical Center, Dallas|