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

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

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

Conditions
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Diabetes, Gastric Bypass

Intervention / Treatment
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* Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lap-band<br>Patient undergoing Lap-band Bariatric Surgery | Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp<br>* 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.<br>* Other names: MMTT;|
| Active Comparator: Gastric Bypass<br>Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery. | Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp<br>* 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.<br>* Other names: MMTT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of gastric by-pass surgery to decrease lipotoxicity. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, MIDAS, gut hormones, gastric bypass, lap band