None listed
Conditions
Brief summary
This project will examine the effect of weight loss induced by the administration of the GLP-1 analogue, liraglutide, in combination with bariatric surgery or medical management on factors associated with metabolic and end-organ abnormalities. It is likely that liraglutide will improve the metabolic and neurohormonal profile of patients with obesity. Complications of obesity including cardiac pathology, neurocognitive dysfunction and sleep-disordered breathing may improve as a result of weight loss, with the use of a GLP-1 analogue.
Interventions
Patients who have elected to have bariatric surgery or medical management for weight loss will be randomised to receive 1.8mg liraglutide daily, administered subcutaneously, for 12 months. Participants will commence liraglutide/placebo treatment within 2 weeks of bariatric surgery taking place or starting medical management for obesity.
Participants will be asked to return any unused study drug at each study visit; this will be used as a way to monitor adherence to the study medication protocol.
Patients who have elected to have bariatric surgery or medical management for weight loss will be randomised to receive 1.8mg liraglutide daily, administered subcutaneously, for 12 months. Participants will commence liraglutide/placebo treatment within 2 weeks of bariatric surgery taking place or starting medical management for obesity. Participants will be asked to return any unused study drug at each study visit; this will be used as a way to monitor adherence to the study medication protocol. Furthermore, fasting blood glucose will be measured at each study visit, as a way of monitoring glycaemic control in the study participants.
Sponsors
Northern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
Outcome results
None listed