A clinical trial to evaluate the effect of spironolactone and amiloride on prevention of rosiglitazone induced fluid retention in patients with type 2 diabetes

Randomized study to evaluate the role of spironolactone and amiloride in the prevention of Rosiglitazone induced fluid retention in Type 2 Diabetes - -

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/05/002697

Enrollment

180

Registered

2012-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Fluid Induced Type II Diabetes mellitus of Rosiglitazone

Interventions

Intervention1: Spironolactone and Rosigliazone: 50mg orally once a day for 6 months Intervention2: Amiloride and Rosiglitazone: 10mg orally once a day for 6 months Control Intervention1: Placebo and

Eligibility

Inclusion criteria

Inclusion criteria: Type II Diabetes mellitus Drug Naive subjects Female-post menopausal subjects need to have HbA1C -7 to 15% medications-SU or SU+mET or acarbose

Exclusion criteria

Exclusion criteria: Use of more than 3 oral anti-diabetic agents Never on thiazolidinediones SBP 170 mmHg and DBP 100 mg mm Hg Type I Diabetes mellitus

Design outcomes

Primary

Measure	Time frame
change from control group (RSG+placebo)in HtcTimepoint: change from control group (RSG+placebo)in Htc in 6 months	—

Secondary

Measure	Time frame
Foot and ankle volume Body weight Ankle circumference Extracellular fluid volume Total body water Hemoglobin Plasma albuminTimepoint: 6 months	—

Countries

India

Contacts

Public ContactVijay Viswanathan

MV Hospital for Diabetes and Diabetes Research Centre

drvijay@mvdiabetes.com25954913

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026