None listed
Conditions
Brief summary
Obesity and related cardiometabolic diseases represents an escalating global health challenge, requiring new therapeutic targets. Mineralocorticoid receptors (MRs) are hormone receptors present on fat cells, in high abundance in obese subjects. In animals, blocking the MRs by a tablet called spironolactone protects against obesity and diabetes over time. This project will investigate whether spironolactone provides long-term metabolic benefits in humans. Thirty-two young overweight/obese subjects will be recruited. Half will be randomly assigned to a 16-week treatment with spironolactone and the other half to placebo (medication-free tablet). Assessments including body-composition scan, nuclear imaging using a glucose tracer, calorimetry, blood tests, abdominal fat sampling will be undertaken before and after treatment to determine whether spironolactone improves body fat mass, tissues glucose uptake and function of fat cells. The results will help determine the novel therapeutic potential of MR blockade for management of obesity and metabolic diseases
Interventions
Randomised to either arm 1 (oral spironolactone 100 mg once daily) or arm 2 (oral placebo once daily) for 16 weeks
Double-blinded
Adherence will be assessed by pill counting of returned medication bottles
Sponsors
Dr Moe Thuzar
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 45 Years
Healthy volunteers
No
Inclusion criteria
BMI 25-40 kg/m2
Exclusion criteria
(i) estimated glomerular filtration rate (eGFR) less than 60 ml/min (ii) serum potassium more than 5mmol/L in a non-haemolysed blood sample (iii) thyroid or endocrine dysfunction (iv) significant organ dysfunction such as heart failure, liver failure (v) active malignancy (vi) pregnant or planning pregnancy (vii) unable to provide informed consent (viii) alcohol intake >14 standard drinks per week or smoking (ix) Unable to maintain stable diet and lifestyle during the study period (x) taking medications that may interact with spironolactone or have effect on metabolism such as anti-hypertensives acting on the renin-angiotensin or sympathetic system, diuretics, anti-diabetic medications, corticosteroids, anti-psychotics
Outcome results
None listed