NCT00488423|CompletedPhase 1
Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery
MIDAS
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MIDAS
Sponsor study identifier
interventional
21
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 18, 2007
Actual (reported)June 20, 2007
Actual (reported)November 2008
Actual (reported)November 2008
Actual (reported)To assess the effect of gastric by-pass surgery to decrease lipotoxicity.
One year
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
Patient undergoing Lap-band Bariatric Surgery
Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Sangeeta R. Kashyap, MD
The Cleveland Clinic
Philip R. Schauer, M.D.
The Cleveland Clinic
21 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2008
Actual (reported)Last Updated
June 22, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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