Longitudinal Assessment of Bariatric Surgery Sub-Study

Active, not recruiting

• Conditions: Obesity; Diabetes Mellitus

• Registration Number: NCT02985853
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-07
• Primary Completion: 2021-02-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 39

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight	Up to 72 months	Weight measurements will take place at every visit, up to 72 months after bariatric surgery.
Capillary Blood Glucose	Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.	Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.