Evaluation of the effect of omega-3 fatty acid alone and in combination with Proprietary Chromium Complex (PCC) 200mcg and 400mcg on endothelial dysfunction in subject with type 2 diabetes mellitus

izams Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

发起方

izams Institute of Medical Sciences