Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass

Not Applicable

Withdrawn

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Other: Mix Nutrient Meal; Other: labs; Other: Biopsy; Other: Second Mix Nutrient Meal; Other: Second biopsy; Device: PET/CT

• Registration Number: NCT02288351
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB.

The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2016-12-23
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of Type 2 Diabetes Mellitus
2. Age between 18 and 65 years of age
3. BMI > 35kg/m²
4. Diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.

Read More

Exclusion Criteria

1. Patients undergoing revision from another bariatric procedure to RYGB
2. Presence of a seizure disorder (GLUT-1 deficiency syndrome)
3. Use of Tricyclic antidepressants
4. Use of tobacco products

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RYGB with mucosal abnormality on EGD	Biopsy	Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
RYGB with mucosal abnormality on EGD	Mix Nutrient Meal	Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
RYGB with mucosal abnormality on EGD	labs	Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
RYGB with mucosal abnormality on EGD	Second Mix Nutrient Meal	Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
RYGB with mucosal abnormality on EGD	PET/CT	Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
RYGB with mucosal abnormality on EGD	Second biopsy	Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.

Primary Outcome Measures

Name	Time	Method
Elevated Glut-1 gene and protein expression levels	2 months	Gene and protein expression levels of GLUT-1 will be analyzed from the specimens obtained intra-operatively (baseline) and at 2 months post-operatively to determine if levels are significantly elevated above baseline. Quantitative real-time PCR and Western blot techniques will be utilized as described in C below.

Secondary Outcome Measures

Name	Time	Method
Glut-1 level change in fasting glucose	2 months	Change in GLUT-1 levels will be correlated with changes in fasting glucose, mixed meal stimulation test, and homeostasis model assessment (HOMA). Secondly, at 2 months post-operatively, whole-body positron emission tomography/computed tomography (PET/CT) scanning with Fluorodeoxyglucose (FDG) will be performed to evaluate glucose uptake and utilization in the Roux limb.