Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery (MIDAS)
This study has been completed.
Sponsor:
The Cleveland Clinic
Collaborator:
Ethicon Endo-Surgery
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00488423
First received: June 18, 2007
Last updated: June 21, 2011
Last verified: June 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 18, 2007 | ||||||||
| Last Updated Date | June 21, 2011 | ||||||||
| Start Date ICMJE | November 2006 | ||||||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To assess the effect of gastric by-pass surgery to decrease lipotoxicity. [ Time Frame: One year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
To assess the effect of gastric by-pass surgery to decrease lipotoxicity. [ Time Frame: One year ] | ||||||||
| Change History | Complete list of historical versions of study NCT00488423 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery | ||||||||
| Official Title ICMJE | Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery | ||||||||
| 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. |
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| Detailed Description | Tests performed are the Mixed Meal tolerance test, the Hyperglycemic Clamp test, c-peptide, free fatty acids, adipocyte hormone profile levels. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 21 | ||||||||
| Completion Date | November 2008 | ||||||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 19 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00488423 | ||||||||
| Other Study ID Numbers ICMJE | 8585 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Cleveland Clinic Foundation, Endocrine & Metabolic Institute Research | ||||||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||||||
| Collaborators ICMJE | Ethicon Endo-Surgery | ||||||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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