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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Nov 2014

Shorter than P25 for not_applicable type-2-diabetes

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

November 1, 2014

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

Last Updated

December 26, 2016

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

November 5, 2014

Last Update Submit

December 23, 2016

Conditions

Type 2 Diabetes Obesity

Keywords

Roux-en-Y gastric bypass

Outcome Measures

Primary Outcomes (1)

Elevated Glut-1 gene and protein expression levels
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.
2 months

Secondary Outcomes (1)

Glut-1 level change in fasting glucose
2 months

Study Arms (1)

RYGB with mucosal abnormality on EGD

OTHER

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.

Other: Mix Nutrient MealOther: labsOther: BiopsyOther: Second Mix Nutrient MealOther: Second biopsyDevice: PET/CT

Interventions

Mix Nutrient MealOTHER

Before Surgery: Subjects will have a visit where they will have a mixed nutrient stimulation test. They will be asked to fast for 12 hours prior to this visit (except water). During the visit they will drink an 8 ounce mixed nutrient liquid meal in 5 minute intervals over 20 minutes. During this visit a catheter will be placed in a vein in their arm for blood sample collections. A total of 50 ml of blood will be collected, (10 ml before drinking the mixed nutrient drink, at 30 minutes, at 60 minutes, at 90 minutes and 120 minutes after the mixed nutrient drink).