Health Condition 1: null- Overweight or obese prediabetic subjects with dyslipidemia
Conditions
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects in the age range 30-65 (both inclusive) years Waist circumference in men >=90 cm and women >=80 cm BMI in the range 23-35 (inclusive) kg/m2 ApoB >= 100 mg/dl Triglyceride >=150mg/dl Fasting Blood Glucose >= 100 mg/dl Serum Insulin >= 12 µU/ml Blood pressure: SBP >=130 mmHg and DBP >=85 mmHg with/ without anti-hypertensive treatment
Exclusion criteria
Exclusion criteria: SBP/DBP >=160/100 mmHg. Subjects on Insulin therapy Subjects having FPG 126 mg/dl or HbA1C 6.4 or on antidiabetic medication Serum Triglycerides 400 mg/dL LDL-Cholesterol 300 mg/dl or Medical History/clinical evidence of Familial Hyperlipidemic Disorder. Subjects on anti-hyperlipidemic agents other than statins History of angina, Myocardial Infarction (MI) or stroke within 6 months of screening ALT or AST >= ULN 3 times Alcohol intake (ethanol) 20 ml/day which is equivalent to 40 ml whisky/rum/gin/vodka/hard liquors or 240 ml of beer, or 90 ml of wine per day (averaged for 7 days). eGFR 30 mL/min as evaluated by Cockroft-Gault method Subjects having thyroid dysfunction (TSH 0.3 or 5.0) or euthyroid on thyroid medication or hormone related obesity disorder Seropositive for HIV, Hepatitis B, Hepatitis C Pregnant or lactating females. History of Drug abuse History of psychiatric disorder History of any bleeding disorder History of malignancy in last 3 years Women of child bearing potential on Hormonal contraceptives for the duration of the study. Clinically relevant abnormal physical or laboratory findings at the screening examination as judged by the investigator, which would interfere with the objectives of the study. Intake of any investigational drug within 3 months prior to first dose of study drug. History of significant blood loss due to any reason, including blood donation, in the 12 weeks prior to the first dose of study drug; or the total blood loss in the last 3 months, including for this study, exceeds 450 ml
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apo B Ambulatory BP Fasting Insulin and Fasting Glucose Timepoint: Baseline, Week 12 and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Post-prandial glucose, Insulin & Triglyceride profile after standardized meal 2. Non-HDL Cholesterol & Apo B/ Apo A1 3. Hepatic and Visceral Fat (in subset) Timepoint: 1. Post-prandial glucose, Insulin & Triglyceride profile after standardized meal at baseline and week24. 2. Non-HDL Cholesterol & Apo B/ Apo A1 at baseline, week 12 and Week 24. 3. Hepatic and Visceral Fat (in subset)at Baseline and Week 24. | — |
Countries
India
Contacts
Public ContactDr Purav Thakkar
Torrent Pharmaceuticals Limited
Outcome results
None listed