Diabetes and Gastric By- Pass
|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: NCT01153516|
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : January 23, 2013
|Condition or disease|
|Type 2 Diabetes|
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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- Glucose area under the curve during Mixed Meal Challenge Test [ Time Frame: 9 days ]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
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): 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|