None listed
Conditions
Interventions
Intervention1: Omega-3 Fatty acids: Capsule omega 3 fatty acids 120 mg EPA + 180 mg DHA single dose H.S
Intervention2: &
#945
? lipoic acid + Methyl cobalamine: Capsule of &
- lipoic acid (100 mg B.D) + methyl cobalamine 500mcg O.D
Intervention3: Methyl cobalamine: methyl cobalamine 500mcg O.D
Intervention4: vitaminE: Capsules of vit E 200 mg per day O.D
Intervention5: Pl
Sponsors
MERCK India Ltd
Associated Capsules India
Eligibility
Inclusion criteria
Inclusion criteria: This study will enrol patients both men and women with age between 21-60 years of known cases of type 2 diabetes mellitus, attending medicine or diabetic O.P.D of SGH Pune and having the following parameters -indicative of decreased insulin sensitivity:- Any of the below two criteria: 1)B.M.I > 27 kg/m2 - < 40 kg/m2 17 2)Waist circumference of > 102 cm in men or > 88 cm in women 3)High-density lipoprotein cholesterol (HDL-C) level of < 40 mg/dL in men or < 50 mg/dL in women/ Fasting triglyceride level of 150 mg/dL or higher
Exclusion criteria
Exclusion criteria: 1) Patient with type 2 diabetes mellitus with blood glucose > 250 mg/dL or patients who are currently on insulin therapy17 2) Patients with uncontrolled hypertension ( Blood pressure > 140/90mmHg in spite of anti HT drugs) 3) Patients with complications of diabetes including nephropathy & retinopathy17 4) Patients with serum levels of triglycerides >400 mg/dL17/ Patients with total cholesterol > 400 mg/dL17 5) Any history of MI/cardiac intervention or clinically active cardiovascular disease17 6) Patients with known renal or hepatic diseases ( AST > 82 U/L; ALT > 76 U/L; Creatinine > 1.5mg/dL) 17 including any history of renal stones 7) Pregnant females will be excluded 8) Patients taking any long term medication except anti-diabetic, antilipedimic and antihypertensive medicines. 9) Unwillingness to give blood samples or mental incapacity to take the drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| insulin sensitivity by HOMA and QUICKITimepoint: At start of study and at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Glucose levelsTimepoint: At start of study and every 15 days thereafter;Body mass index ( B.M.I)Timepoint: At Start Of Study And At End Of Study;Serum lipid levelsTimepoint: At Start Of Study And At End Of Study;Serum Malodialdehyde (MDA) levelsTimepoint: At Start Of Study And At End Of Study;serun glycosylated haemoglobinTimepoint: At Start Of Study And At End Of Study | — |
Countries
India
Contacts
Public ContactDr Aaditya Udupa
Outcome results
None listed