on-interventional study to compare metabolic parameters(including lipid tests, insulin sensitivity, liver fat, visceral/ subcutaneous fat)between diabetic and healthy subjects

Not Applicable

Completed

• Conditions: Health Condition 1: null- Diabetic patients

• Registration Number: CTRI/2011/07/001904
• Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

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.

Exclusion Criteria

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%

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of hepatic fat and metabolic (Conventional and Non-conventional) parameters in overweight/obese prediabetic/diabetic subjects with healthy subjectsTimepoint: day 1 and day 2

Secondary Outcome Measures

Name	Time	Method
Correlation trends between hepatic fat and metabolic parameters in overweight/obese diabetic subjectsTimepoint: day 1 and day 2