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Clinical Trials/ACTRN12609000319279
ACTRN12609000319279CompletedNot Applicable

The effect of lapband surgery on weight loss in diabetic Indigenous Australians.

Monash University0 sites210 target enrollmentStarted: May 21, 2009Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
210

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomised controlled trial
Primary Purpose
Treatment

Eligibility Criteria

Ages
20 Years to 60 Years (—)
Sex
All

Inclusion Criteria

  • Patients must:
  • -1. Be Indigenous people who suffer obesity and type 2 diabetes
  • -1. Agree to comply with the procedures of the study including questionnaire assessment
  • 2.Have no history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
  • 3.Be free of medical issues which contra-indicated the proposed treatments. These may include acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, pregnancy or intending to conceive in the next two years, lactation, severe alcohol or drug abuse, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
  • 4.Be able to understand the Lapband (LAGB) procedure and its potential for benefit and risk.

Exclusion Criteria

  • Patients would be excluded from entry -:
  • 1.If there was lack of acceptance of the procedures of the study including questionnaire assessment
  • 2.If there was a history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
  • 3.If there were medical issues which contra-indicated the proposed treatments. These may include acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, pregnancy or intending to conceive in the next two years, lactation, severe alcohol or drug abuse, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
  • 4.If there was an inability to understand the LapBand (LAGB) procedure and its potential for benefit and risk or were unable to understand or agree to the aftercare process.

Investigators

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