A Non-Interventional, Multi-centric Study to Compare Hepatic fat and Relevant Metabolic Parameters in Overweight/Obese Prediabetic/Diabetic Subjects, with Healthy Subjects in different geographical regions in India

Torrent Pharmaceuticals Limited0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•For Patients:
•1.Ethnicity Indian
•2.Overweight/Obese adult male and female subjects in the age range 30-65 years, body mass index (BMI) 23-35 kg/m2
•3.Waist circumference: men 90 cm, women 80 cm
•4.Glycosylated haemoglobin (HbA1C) 5.7% to 6.4% and Fasting blood sugar (FBS) greater than 100 mg/dl OR diagnosed case of diabetes on anti-diabetic medication or undiagnosed with HbA1C greater than 6.4%
•5.Systolic Blood Pressure greater than 130 mmHg and Diastolic Blood Pressure greater than 85 mmHg Or Subjects on Anti-hypertensive medication.
•6.Serum Triglycerides greater than 150 mg/dl
•7.Willingness to give written informed consent (prior to any study related procedures being performed) and ability to adhere to the study restrictions and assessments schedule.
•For Healthy volunteers:
•1.Ethnicity Indian
•2.Male and female subjects of age group 30 - 65 years. (both inclusive),
•3.Volunteer with BMI of 18.5 to 23 (inclusive both) kg/m2
•4.Non-alcoholic or Alcohol intake less than 20 ml/day ethanol 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 out for 7 days).
•5.Healthy and willing to participate in the study.
•6.Volunteer willing to adhere to the protocol requirements and to provide written informed consent.

•Glycosylated haemoglobin (HbA1C) 5.7% to 6.4% and fasting blood sugar (FBS) more than 100 mg/dl OR diagnosed case of diabetes on anti-diabetic medication or undiagnosed with HbA1C greater than 6.4%

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