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To aim of this study is to determine the prevalence of Non-Alcoholic Fatty Liver Disease and Thyroid Dysfunction in Patients with Metabolic Syndrome.

Not Applicable
Conditions
Health Condition 1: null- Patients with an established diagnosis of MetS as per the ATP III criteria and visiting the clinic as a part of their schedule
Registration Number
CTRI/2016/09/007270
Lead Sponsor
Abbott India Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
400
Inclusion Criteria

1.Male and female patients, aged 18 to 65 years inclusive

2.Patients with an established diagnosis of MetS as per the ATP III criteria and visiting the clinic as a part of their schedule

Exclusion Criteria

1.Patients with history of drug intake likely to cause NAFLD (e.g. aspirin, amiodarone, corticosteroids, methotrexate, 5-fluorouracil, tamoxifen, valproate, zidovudine, didanosine, diltiazem) or TD (e.g. interferon, molecular-targeted agents, amiodarone, thyroid hormone, anti-thyroid drugs, lithium, iodine, dopamine)

2.Patients with history of jejuno-ileal bypass or biliopancreatic diversion or extensive small bowel resection or total parenteral nutrition.

3.Evidence of other forms of chronic liver disease, suspected or confirmed hepatocellular carcinoma, known HIV positive

4.Female patients who are pregnant

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Percentage of patients with NAFLD amongst the patients with MetS (diagnosed as per ATP III criteria), visiting the Endocrinology and Gastroenterology outpatient departments (OPD) in India. <br/ ><br>2.Percentage of patients with TD amongst the patients with MetS (diagnosed as per ATP III criteria), visiting the Endocrinology and Gastroenterology outpatient departments (OPD) in India.Timepoint: 8 months recruitment period
Secondary Outcome Measures
NameTimeMethod
1.Demographic characteristics, clinical and laboratory profile of Indian patients with MetS. <br/ ><br>2.Percentage of patients categorized into high, intermediate and low probability for advanced fibrosis as per NFS <br/ ><br>3.Percentage of TD patients with hyperthyroidism, subclinical hyperthyroidism, hypothyroidism and subclinical hypothyroidism <br/ ><br> <br/ ><br>Due to word limit the remaining 4 secondary endpoints have not been captured.Timepoint: 6 months
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