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Clinical Trials/CTRI/2011/07/001904
CTRI/2011/07/001904
Completed
未知

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 sites150 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Diabetic patients
Sponsor
Torrent Pharmaceuticals Limited
Enrollment
150
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Eligibility 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

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%

Outcomes

Primary Outcomes

Not specified

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