Diabetes and Gastric By- Pass

The University of Texas System (UT)

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT01153516

122009-049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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