None listed
Conditions
Brief summary
Obesity is common in Aboriginal and Torres Strait Islander communities and increases the risk of type 2 diabetes and heart disease. This WA-based study, designed in partnership with Aboriginal health and community groups, will test whether a medication called semaglutide (already shown to reduce weight and improve blood sugar and heart risk in other groups) can help improve health outcomes in Aboriginal people. The study will involve 200 Aboriginal or Torres Strait Islander participants, who will be supported with healthy eating, exercise, and regular check-ins. Some will receive weekly semaglutide injections, while others will receive a placebo. The study will measure changes in weight, blood pressure, blood sugar, and heart health over two years. This is the first trial of its kind in Aboriginal Australians and aims to guide future care.
Interventions
Semaglutide 0.25 mg subcutaneous injection weekly administered by healthcare professional and uptitrating every 4 weeks to 0.5 mg weekly, 1 mg weekly, 1.7 mg weekly and to a maximum of 2.4 mg weekly as tolerated; total duration of treatment will be 52 weeks. This will be in addition to background lifestyle support. Initial dietary education will occur as a 1 hour group session (up to 10 participants) led by a dietitician, which will be followed by sessions every three months at community centres
Semaglutide 0.25 mg subcutaneous injection weekly administered by healthcare professional and uptitrating every 4 weeks to 0.5 mg weekly, 1 mg weekly, 1.7 mg weekly and to a maximum of 2.4 mg weekly as tolerated; total duration of treatment will be 52 weeks. This will be in addition to background lifestyle support. Initial dietary education will occur as a 1 hour group session (up to 10 participants) led by a dietitician, which will be followed by sessions every three months at community centres led by a trained Aboriginal Health Worker. 1 hour exercise classes will be running weekly at the community centre supervised by. an exercise physiologist or physiotherapist so that participants are provided with a personalised exercise plan. These exercise classes may include a combination of aerobic and anaerobic exercises. Weekly check in duration of 15 minutes will occur one-on-one face-to-face with an Aboriginal Health Worker at the community centre, who will check on any side-effects, general well-being, and administer the injection.
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Aboriginal or Torres Strait Islander person aged 30-60 years with body mass index (BMI) =>30 kg/m2 or aged 18-30 years with BMI =>30 kg/m2 plus at least one other cardiovascular risk factor (e.g., hypertension, diabetes or dyslipidaemia, smoking, or family history of cardiovascular disease).
Exclusion criteria
• Prior use of agent targeting glucaon-like peptide-1 (GLP-1) receptor or GLP-1 and gastric inhibitory polypeptide (GIP) receptors. • Type 2 diabetes requiring more than oral glucose-lowering therapies. • Type 1 diabetes. • Prior or planned bariatric/metabolic surgery for weight loss. • Known significant gastric emptying abnormality (e.g., gastroparesis or gastric outlet obstruction). • Known severe coronary artery disease or prior myocardial infarction. • Known active or untreated malignancy or in remission from a clinically significant malignancy. • Other major medical comorbidities which may complicate participation in the study. • History of acute or chronic pancreatitis. • Excessive alcohol consumption. • Severe mental health condition. • History of multiple endocrine neoplasia syndrome (MEN) type 2 or medullary thyroid carcinoma. • Renal impairment with an estimated glomerular filtration rate of <30 ml/min/1.73m2. • Known iodinated contrast anaphylaxis. • Inability to provide informed consent. • Pregnant or breastfeeding women.
Outcome results
None listed