Evaluation of effect of chromium compounds on endothelial dysfunction and lipid profile in type 2 diabetics
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitus
- Registration Number
- CTRI/2017/08/009489
- Lead Sponsor
- Dr C Uday Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
1.patients with fasting plasma glucose levels of 110-126 mg/dL 2.glycosylated haemoglobin (HbA1c) between 6.5 % and 8% 3. taking stable dose of anti-diabetic treatment (metformin 1500-2000 mg/day) for the past 8 weeks prior to the screening visit 4. those who have endothelial dysfunction defined as <= 6% change in reflection index (RI) on post salbutamol challenge test
Exclusion Criteria
Patients with severe uncontrolled hyperglyceamia, uncontrolled hypertension, cardiac arrhythmia, impaired hepatic or renal function, history of malignancy or stroke, smoking, chronic alcoholism, any other serious disease requiring active treatment and treatment with any other herbal supplements, were excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in endothelial dysfunction as assessed by more than 6% change in reflection index at 12 weeks in all the treatment groups.Timepoint: at the end of 12 weeks
- Secondary Outcome Measures
Name Time Method change in glycosylated hemoglobin (HbA1c) and lipid profileTimepoint: at 12 weeks;change in oxidative stress markers glutathione (GSH), malondialdehyde (MDA), serum levels of nitric oxide (NO), high-sensitivity C-Reactive Protein (hsCRP)Timepoint: at 12 weeks