Distribution and treatment of non alcoholic fatty liver disease in Indian people with diabetes and obesity related conditions

Recruiting

• Conditions: Non Alcoholic Fatty Liver Disease

• Registration Number: CTRI/2014/07/004725
• Lead Sponsor: Osmania General Hospital

Brief Summary

This is  an observational study that will determine the prevalence and incidence of Non Alcoholic Fatty Liver Disease (NAFLD) in Patients with Diabetes and Metabolic syndrome.This study will also follow up with patients receiving treatment for NAFLD as per current guidelines and standard of care.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-26
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Patients with Type II Diabetes Mellitus and Metabolic Syndrome a.Fasting Blood Sugar >120 mg/dL b.Metabolic Syndrome diagnosed as per NCEP- ATP III criteria.
• 2.Patients with age ≥18 years.
• 3.Patient with stable dose of diabetic medication for last three months.
• 4.Alcohol intake of < 21 units/week for men and < 14 units/week for women.

Exclusion Criteria

• 1.Patient taking Thiazolidinedione’s 2.Patients with cirrhosis.
• 3.Patients with NYHA class III-IV.
• 4.Patients having neurological disease.
• 5.Patient with uncontrolled blood pressure( 3 antihypertensive medication) 6.Patients on Drugs known to induce fatty liver such as methotrexate, estrogens, tamoxifen and amiodarone.
• 7.Unable to be followed for the duration of the clinical trial 8.Inability to obtain informed consent.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a)To assess the prevalence and incidence of Non-Alcoholic Fatly Liver Disease (NAFLD) in patients with Diabetes and Metabolic Syndrome.	From enrollment
b)Anthropometric measures.	From enrollment

Secondary Outcome Measures

Name	Time	Method
AST aspartate aminotransferase at the end of three months of treatment.	from enrollment to 3 months
ALT alanine aminotransferase at the end of three months of treatment.	From enrollment to 3 months

Trial Locations

Locations (1)

Osmania General Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Osmania General Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Rakesh Kumar Sahay

Principal investigator

9849597507

sahayrk@gmail.com