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Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes

D

David Bradley MD

Status

Completed

Conditions

Type 2 Diabetes Mellitus
Obesity

Treatments

Procedure: Roux-en-Y gastric bypass surgery
Other: Best Medical Management
Other: Laboratory evaluations, sleep study

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01044602
2009H0282
MS vs. MM for DM2 (Other Identifier)

Details and patient eligibility

About

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).

Full description

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).

Enrollment

120 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Best Medical Management
Active Comparator group
Description:
Patients elect to treat obesity and type 2 diabetes mellitus through best medical management.
Treatment:
Other: Best Medical Management
Other: Laboratory evaluations, sleep study
Surgical Treatment
Active Comparator group
Description:
Patients with type 2 diabetes mellitus choice to treat obesity with Roux-en-Y gastric bypass.
Treatment:
Other: Laboratory evaluations, sleep study
Procedure: Roux-en-Y gastric bypass surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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