Diabetes, Gastric Bypass
Conditions
Keywords
diabetes, MIDAS, gut hormones, gastric bypass, lap band
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.
Interventions
PROCEDUREMixed 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.
Sponsors
Ethicon Endo-Surgery
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of gastric by-pass surgery to decrease lipotoxicity. | One year |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed