Weight Loss and Type 2 Diabetes: A prospective randomised controlled trial intervention study of best practice medical management versus the additional placement of the Lap-Band System in overweight patients

Not Applicable

Completed

• Conditions: Obesity; Diabetes Type 2; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12609000286246
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Be between 18 and 65 years of age, 2. Have a body mass index greater than 25 and less than 30 kg/m2. 3. Have been diagnosed with type 2 diabetes in the last 5 years. 4. Be able to understand the options and study requirements and to comply with the requirements of each program. 5. Willing to be randomized.

Exclusion Criteria

1.If there was lack of acceptance of the randomization process,
2.If there were a history of previous abdominal surgery which would potentially preclude laparoscopic placement of the band.
3.If there was a history of previous obesity surgery
4.If there were any contraindication to LapBand (LAGB) placement.
5.If there were medical issues which contra-indicated 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, pregnancy or intending to conceive in the next two years, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure.
6.Systemic lupus erythematosis or other auto-immune disease.
7.Direct hypothalamic damage as a cause of obesity.
8.If they were unable to understand the risks, realistic benefits and compliance requirements of the Lap-Band intervention and conventional management of diabetes.
9.The patient had type 1 diabetes or diabetes was secondary to specific diseases such as haemachromatosis or chronic pancreatitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of co-morbidity control including abnormalities of blood pressure, serum lipids and liver function (via measurement of liver enzymes concentrations)[3, 6, 9, 12, 24, and 60];Resolution of diabetes (fasting and 2h glucose following 75g oral glucose <7.1 and <11.1 respectively)[months 24 and 60];Biochemical assessment of glycaemic control of type 2 diabetes (HbA1c, fasting glucose)[3,6,9,12,24, and 60]

Secondary Outcome Measures

Name	Time	Method
Clinical measures related to metabolic syndrome (eg lipids, waist circumference, medication burden, BP)[months 3, 6, 9, 12 and 60];Cost effectiveness - via technical efficiency analysis, which will draw on both the primary data collections from the trial (costs of the intervention; change in weight; cases of diabetes resolved; change in functional status), as well as economic modelling.[12 and 60 months];Weight loss will be measured by Excess weight lost in kilograms (EWL) or Body Mass Index (BMI) points lost[months 3, 6, 9, 12 and 60];insulin and C-peptide response to 25g IV glucose[Months 12 and 60]