The Control of Diabetes through Weight Loss in Indigenous Diabetes

Completed

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12609000319279
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The central aim of the study is to achieve a substantial and durable weight loss. The principal outcome is the frequency of remission of type 2 diabetes in response to this weight loss. Additional outcomes would include measure of side effects and complications, compliance, acceptability and costs. <br>Weight loss and frequency of diabetes remission will be measured by clinical assessments (weight lost via full medical history, examination by health professional), collection of tissue/ fluid (blood results indicating diabetes status)[Each participant would be engaged in a process of care for their diabetes which would begin with a detailed clinical assessment (including baseline data collection). There would be an operative procedure involving an overnight hospital stay and then data would be collected fortnightly over a two year period.]

Secondary Outcome Measures

Name	Time	Method
Compliance (subjects band compliance and acceptance) - via questionaires, focus groups[Data would be collected fortnightly over a two year period.]