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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2011/07/001904
Enrollment
150
Registered
2011-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetic patients

Interventions

Control Intervention1: "NIL": "NIL"

Sponsors

Torrent Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

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%

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Correlation trends between hepatic fat and metabolic parameters in overweight/obese diabetic subjectsTimepoint: day 1 and day 2—

Countries

India

Contacts

Public ContactDr Lalit Lakhwani

Torrent Pharmaceuticals Limited

lalitlakhwani@torrentpharma.com91-79-23969100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026