Distribution and treatment of non alcoholic fatty liver disease in Indian people with diabetes and obesity related conditions
- Conditions
- Health Condition 1: null- Non Alcoholic Fatty Liver Disease
- Registration Number
- CTRI/2014/07/004725
- Lead Sponsor
- Osmania General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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.
1.Patient taking Thiazolidinedioneâ??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. <br/ ><br>b)Anthropometric measures.Timepoint: From enrollment
- Secondary Outcome Measures
Name Time Method ALT alanine aminotransferase at the end of three months of treatment.Timepoint: From enrollment to 3 months;AST aspartate aminotransferase at the end of three months of treatment.Timepoint: from enrollment to 3 months