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

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ClinicalTrials.gov Identifier: NCT00488423
Recruitment Status : Completed
First Posted : June 20, 2007
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Diabetes Gastric Bypass Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Official Title: Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery
Study Start Date : November 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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Arm Intervention/treatment
Active Comparator: Lap-band
Patient undergoing Lap-band Bariatric Surgery
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.
Other Name: MMTT
Active Comparator: Gastric Bypass
Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery.
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.
Other Name: MMTT



Primary Outcome Measures :
  1. To assess the effect of gastric by-pass surgery to decrease lipotoxicity. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: One Year ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488423


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Ethicon Endo-Surgery
Investigators
Principal Investigator: Sangeeta R. Kashyap, MD The Cleveland Clinic
Principal Investigator: Philip R. Schauer, M.D. The Cleveland Clinic

Responsible Party: Cleveland Clinic Foundation, Endocrine & Metabolic Institute Research
ClinicalTrials.gov Identifier: NCT00488423     History of Changes
Obsolete Identifiers: NCT00554593
Other Study ID Numbers: 8585
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by The Cleveland Clinic:
diabetes
MIDAS
gut hormones
gastric bypass
lap band