Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery - Full Text View

Sponsor:	The Cleveland Clinic
Collaborator:	Ethicon Endo-Surgery
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00488423

Purpose

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	Intervention	Phase
Diabetes Gastric Bypass	Procedure: Mixed Meal Tolerance test, Hyperglycemic clamp	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor)
Official Title:	Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines Weight Loss Surgery

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

To assess the effect of gastric by-pass surgery to decrease lipotoxicity. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	21
Study Start Date:	November 2006
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Cleveland Clinic Foundation, Endocrine & Metabolic Institute Research
ClinicalTrials.gov Identifier:	NCT00488423 History of Changes
Obsolete Identifiers:	NCT00554593
Other Study ID Numbers:	8585
Study First Received:	June 18, 2007
Last Updated:	June 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

diabetes
MIDAS
gut hormones
gastric bypass
lap band

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012