The combined effect of Liraglutide and Sleeve Gastrectomy on Metabolic, Cardiac, Neurological and Sleep Function in Obese Diabetes: A Twelve-Month Randomised Study.

Phase 3

Active, not recruiting

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

• Registration Number: ACTRN12613001069741
• Lead Sponsor: orthern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Subjects diagnosed with type 2 diabetes mellitus who have elected to undergo bariatric surgery or medical management for weight loss
- Body mass index greater than 35kg/m2 or 30kg/m2 with at least 2 medical co-morbidities
- Body weight less than 150kg; waist circumference less than 150cm
- HbA1c: 7%-10% (both inclusive) in subjects on anti-diabetes combination therapy
- HbA1c: 7%-11% (both inclusive) in subjects on anti-diabetes monotherapy

Exclusion Criteria

- Impaired liver function, defined as alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (one retest within one week is permitted with the results from the last sample being conclusive)
- Impaired renal function, defined as serum-creatinine greater than or equal to 135umol/l for males and 110umol/l for females (one retest within one week is permitted with the results from the last sample being conclusive)
- Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class III and IV) at the discretion of the Investigator
- Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
- Recurrent major hypoglycaemia as judged by the Investigator
- Use of any drug (except for anti-diabetes medication), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
- Pregnancy or lactation
- History of pancreatitis or pancreatic cancer
- Patients with a past history of GLP-1 analogue associated pancreatitis
- History of medullary thyroid cancer
- Contraindications to liraglutide or any of its excipients
- Hypersensitivity to liraglutide or similar drugs
- Suspected or known abuse of alcohol or narcotics

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in body weight, as assessed by standard anthropometric measures, such as weight, height, waist circumference, BMI calculation and body composition (evaluated by dual x-ray absorptiometry).[12 months]