Mechanisms of Glycemic Improvement After Gastrointestinal Surgery

Completed

Conditions studied: Diabetes Mellitus, Type II

In brief

This study is designed as a prospective clinical trial aimed at investigating the mechanisms behind observed improvements in type 2 diabetes mellitus (T2DM) following bariatric surgery. The majority of patients with T2DM who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, in particular, experience complete remission of T2DM almost immediately post-surgery. This response occurs before significant weight loss is possible. To assess the mechanisms involved with disease resolution, the investigators propose a study to evaluate patients at the UW Medical Center (UWMC) who have T2DM and are undergoing RYGB with G (gastronomy)-tube placement as part of their clinical care. The investigators are interested in this sub-population as the G-tube allows us the unique opportunity to evaluate glycemic control and insulin response following delivery or exclusion of nutrients to the otherwise bypassed portion of the gastrointestinal tract. The investigators hypothesize that nutrient delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved in glucose control.

Key facts

Study ID

NCT01025999

Run by

University of Washington

People needed

7

Starts

2010-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or greater and planning to undergo RYGB at UWMC
• Ability to speak English and communicate effectively with research staff
• Ability to return for follow-up visits at UWMC
• Adequate IV access
• A G-tube is planned as part of the bariatric surgical procedure
• Documented T2DM (fasting plasma glucose >125 mg/dL) that is treated with lifestyle efforts or by taking acceptable oral medications

You may not qualify if…

• Informed consent not obtained
• Unlikely to comply with the protocol
• Current HbA1c >8.5% or fasting blood glucose >180 mg/dL
• Serum creatinine >1.7 mg/dL
• Use of unacceptable diabetes medications at baseline

Where it is running

• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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