Clinical trial NCT01153516: Diabetes and Gastric By- Pass
Official title: Unraveling the Mechanisms of Rapid Improvement in Diabetes Following Gastric By-Pass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Bariatric surgery
Obesity
Weight loss
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bariatric surgery clinical roster or by the treating physician in the bariatric surgery clinic.

This study does NOT pay for the By-pass surgery, eligible participants should have planned their surgery by their own physician, at their own expense.

Brief summary: 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.

Detailed description: 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.

Wash-out 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.

Eligibility criteria: Inclusion Criteria:

* volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.

Exclusion Criteria:

* abnormal renal function
* significant anemia
* difficult venous access
* treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
* recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance.
* pregnancy
* non -English speakers

Primary outcomes:
measure: Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery
timeFrame: 4-12 weeks
measure: Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery
timeFrame: 4-12 weeks
measure: Response in Glucagon AUC at Baseline vs. Following Gastric Bypass
timeFrame: 4-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical and Translational Research Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center, Dallas
name: Ildiko Lingvay, MD, MPH, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lingvay I, Guth E, Islam A, Livingston E. Rapid improvement in diabetes after gastric bypass surgery: is it the diet or surgery? Diabetes Care. 2013 Sep;36(9):2741-7. doi: 10.2337/dc12-2316. Epub 2013 Mar 25.