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NCT Number: NCT01044602

Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 25 to 70
  • BMI 35 or greater
  • HbA1c>6.5%
  • Stable weight
  • Stable medications

Exclusion criteria

  • Coagulopathy
  • Liver cirrhosis
  • C-peptide <1 ng/ml (off insulin)
  • Diagnosis of severe eating disorder
  • Untreated endocrine disorder
  • Use of medication for weight loss in the past 6 months
  • Use of medication for weight loss in the last 6 months (with the exception of orlistat)
  • Pregnancy
  • Coagulopathy
  • Liver cirrhosis
  • Incurable, malignant, or debilitating disease
  • Severe eating disorder
  • Use of weight loss medication in the last 6 months, with the exception of orlistat
  • Untreated endocrine disorder
  • Pregnant
  • Inability to provide informed consent

Treatment and study plan

Laboratory evaluations, sleep study

Other

Fasting plasma glucose, liver function tests, chem-7, HOMA-IR, HBA1C, lipid profile, indirect calorimetry.

best medical management

Other

Standard of care.

Roux-en-Y gastric bypass surgery

Procedure

Surgical treatment.

Primary outcomes

  1. Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.

    Time frame: 2 years

  2. Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia

    Time frame: 2 years

Secondary outcomes

  1. Improvement in glucose control

    Time frame: 2 years

  2. Improvement in control of chronic co-morbidities

    Time frame: 2 years

  3. Identify predictors of success with regard to improved co-morbidities and velocity of weight loss

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

David Bradley MD

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2010
Registry last updated
Apr 21, 2015

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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