Improving Diabetes After Bariatric Surgery

Obesity Clinical Trial

— LABS-3  

Official title:

LABS-3 Diabetes: Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676923
• Other study ID #: DK6657_3b
• Secondary ID: U01DK066557
• Status: Completed
• Phase: N/A
• First received: May 9, 2008
• Last updated: November 12, 2012
• Start date: March 2008
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

Description:

The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM.

Funds are not available to pay for the surgery for patients, only to address research questions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.

• Enrollment in LABS-1 or LABS-2.

• Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.

• Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.

• Adequate IV access.

Exclusion Criteria:

• Informed consent not obtained.

• Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.

• Creatinine greater than 1.7.

• Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.

• Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Obesity

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Legacy Good Samaritan Hospital	Portland	Oregon
United States	Oregon Health and Science University	Portland	Oregon
United States	University of Washington	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

External Links

•   Link