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Completed

NCT Number: NCT00488423

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

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Gastric Bypass Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixed Meal Tolerance test, Hyperglycemic clamp

Procedure

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 names: MMTT

Primary outcomes

  1. To assess the effect of gastric by-pass surgery to decrease lipotoxicity.

    Time frame: One year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Ethicon Endo-Surgery

Registry information

Official study title

Glucose Metabolism in the Immediate and Short Term Follow up From Bariatric Surgery

Acronym: MIDAS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2007
Registry last updated
Jun 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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