The effect of weight loss on Type 2 Diabetes: a prospective randomized controlled trial of best practice medical management versus the placement of the Lap-Band System on HbA1c concentration.

Phase 4

Completed

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

• Registration Number: ACTRN12605000159651
• Lead Sponsor: Centre for Obesity Research and Education (CORE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients will have a BMI greater than 30 and less than 40kg/m2, have been diagnosed with Type 2 diabetes within the last two years, have no evidence of renal impairment, microalbuminuria or retinopathy, be able to understand the options and study requirements and to comply with the either arm of the study, and be willing to be randomized.

Exclusion Criteria

Unwillingness to accept the randomization process, history of previous abdominal surgery which would potentially preclude laparascopic placement of the band, a history of previous obesity surgery, any contraindication to Lap-Band placement, medical issues which contraindicated the application of either arm of the study (these would include; acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure) , systemic lupus erythematosis or other auto-immune disease, direct hypothalamic damage as a cause of obesity, inability to understand the risks, realistic benefits and compliance requirements of the Lap-Band intervention and conventional management of diabetes, Type 1 diabetes or diabetes secondary to specific diseases foe example haemochromatosis or chronic pancreatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The biochemical assessment of glycaemic control of Type 2 diabetes using HbA1c concentration[At 2 years from randomisation]