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

Diabetes Clinical Trial

— MIDAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488423
• Other study ID #: 8585
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2007
• Last updated: June 21, 2011
• Start date: November 2006
• Est. completion date: November 2008

Study information

• Verified date: June 2011
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Other known NCT identifiers

• NCT00554593

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes
• Gastric Bypass

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of gastric by-pass surgery to decrease lipotoxicity.		One year	Yes
Secondary	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	Yes