Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery

Phase 1

Completed

• Conditions: Diabetes; Gastric Bypass
• Interventions: Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp

• Registration Number: NCT00488423
• Lead Sponsor: The Cleveland Clinic

Brief Summary

MIDAS involves an assessment of glucose levels obtained before and after bariatric surgery. There are two different procedural tests involved; an oral glucose tolerance test (mixed meal) and a hyperglycemic clamp test. Two tests are performed preoperatively and five more are performed postoperatively for a one year period. The associated labwork drawn with the mixed meal and clamp tests are demonstrating changes in glucose, insulin and gut hormone levels.

Detailed Description

Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-06-18
• Study First Submitted QC: 2007-06-19
• Study First Posted: 2007-06-20
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Negative pregnancy test if female
• ADA criteria for diabetes type II
• Hematocrit > 35 creatinine < 1.9, AST < 3X upper limit of normal, ALT < 3X upper limit of normal, alkaline phos <3X upper limit of normal
• Eligibility for bariatric surgery based on the NIH and clinical criteria
• Mentally and legally capable of providing consent

Exclusion Criteria

• Lactating females
• Must not have type I diabetes
• Systemic steroids taken within 6 months
• Clinically significant heart disease
• Recent pulmonary embolism, untreated proliferative retinopathy, renal failure, uncontrolled hypertension, autonomic neuropathy, resting heart rate > 100, neuromuscular or musculoskeletal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lap-band	Mixed Meal Tolerance test, Hyperglycemic clamp	Patient undergoing Lap-band Bariatric Surgery
Gastric Bypass	Mixed Meal Tolerance test, Hyperglycemic clamp	Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery.

Primary Outcome Measures

Name	Time	Method
To assess the effect of gastric by-pass surgery to decrease lipotoxicity.	One year

Secondary Outcome Measures

Name	Time	Method
To examine the effect of roux-en-Y compared to gastric banding on pancreatic B cell recovery or insulin secretion in response to oral and IV glucose.	One Year

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States