NCT00488423

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Gastric Bypass

Interventions

Type	Name	Description
PROCEDURE	Mixed Meal Tolerance test, Hyperglycemic clamp	Subjects undergo a standard mixed meal tolerance test \& hyperglycemic clamp to assess insulin secretion \& sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp \& mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting \& specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass \& gastric banding.

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-06-20
• Last updated: 2011-06-22

Locations

1 site across 1 country: United States