A clinical trial to evaluate the effect of spironolactone and amiloride on prevention of rosiglitazone induced fluid retention in patients with type 2 diabetes
Phase 3
Completed
- Conditions
- Health Condition 1: null- Fluid Induced Type II Diabetes mellitus of Rosiglitazone
- Registration Number
- CTRI/2012/05/002697
- Lead Sponsor
- Diabetes Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change from control group <br/ ><br>(RSG+placebo)in HtcTimepoint: change from control group <br/ ><br>(RSG+placebo)in Htc in 6 months
- Secondary Outcome Measures
Name Time Method Foot and ankle volume <br/ ><br>Body weight <br/ ><br>Ankle circumference <br/ ><br>Extracellular fluid volume <br/ ><br>Total body water <br/ ><br>Hemoglobin <br/ ><br>Plasma albuminTimepoint: 6 months