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

NCT ID: NCT00488423

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-11-30

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.

Conditions

Diabetes; Gastric Bypass

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Lap-band

Patient undergoing Lap-band Bariatric Surgery

Group Type: ACTIVE_COMPARATOR

Mixed Meal Tolerance test, Hyperglycemic clamp

Intervention Type: PROCEDURE

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.

Gastric Bypass

Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery.

Group Type: ACTIVE_COMPARATOR

Mixed Meal Tolerance test, Hyperglycemic clamp

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

MMTT

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Endocrine & Metabolic Institute Research

Principal Investigators

Sangeeta R. Kashyap, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Philip R. Schauer, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

8585

Identifier Type: -

Identifier Source: org_study_id

NCT00554593

Identifier Type: -

Identifier Source: nct_alias