Effect of omega-3 fatty acid in type 2 diabetes.
- Conditions
- Health Condition 1: null- Type 2 diabetes mellitus patientsHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2018/05/013547
- Lead Sponsor
- izams Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Male and female subjects between 30-65 years and willing to give informed consent and comply with protocol related study procedures.
2. Fasting plasma glucose of 110-126 mg/dL.
3. Glycosylated haemoglobin (HbA1c) between 6.5 % and 8%.
4. Patients on stable dose of anti-diabetic treatment (metformin 1500-2500 mg/day) for the past 8 weeks prior to the screening.
5. Patients with endothelial dysfunction â?? (salbutamol challenge test) documented as decrease in RI index by <6%.
6. Subjects not on any investigational products in the past 6 months.
1. Subjects with abnormal hematological or biochemical parameters considered significant by investigator.
2. Uncontrolled diabetes (HbA1c > 8% and FBS > 210 mg/dl).
3. Uncontrolled hypertension ( SBP >180mmHg and DBP >100mmHg).
4. Serum Triglycerides >500mg/dl.
5. AST and ALT elevation >3 times upper limit of normal.
6. Serum creatinine more than 1.5 mg/dl.
7. On any other dietary or herbal supplements.
8. Any medical condition where physician feels participation in the study could be detrimental to subjects well being.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in endothelial dysfunction as assessed by more than 6% change in reflection index at 12 weeks in all the treatment groups.Timepoint: 0, 4, 8, 12 weeks
- Secondary Outcome Measures
Name Time Method Change in biomarkers from baseline to end of 12 weeks therapy in all the treatment groups.Timepoint: 0, 4, 8, 12 weeks