Effects of Mineralocorticoid Receptor Blockade on Metabolism - A Clinical Trial

Phase 2

• Conditions: Obesity; Metabolic and Endocrine - Metabolic disorders; Diet and Nutrition - Obesity

• Registration Number: ACTRN12618001958279
• Lead Sponsor: Dr Moe Thuzar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-04
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total fat mass on dual energy X-ray absorptiometry (DEXA) scan<br><br>[at 16 weeks post-treatment];Change in insulin sensitivity assessed by hyperinsulinaemic-euglycaemic clamp[at 16 weeks post-treatment]

Secondary Outcome Measures

Name	Time	Method
Change in brown adipose tissue activity assessed by 18F-Fluorodeoxy-glucose Positron-emission-tomography-CT (FDG-PET-CT)[at 8 weeks post-treatment];Changes in the expression of genes involved in metabolism and inflammation in abdominal subcutaneous adipose tissue biopsies (exploratory)[at 8 weeks post-treatment];Change in Body weight measured using digital scale<br><br>[at 16 weeks post-treatment];Change in fasting lipids on blood test (exploratory)[at 16 weeks post-treatment];Change in visceral fat mass on DEXA[at 16 weeks post-treatment];Change in metabolic and substrate oxidation rates assessed by indirect calorimetry (composite)[at 16 weeks post-treatment]