Fatty liver disease in Polycystic ovarian syndrome Indian wome
- Conditions
- Health Condition 1: null- Infertility patients attending the outpatient infertility clinic at Department of Obstetrics and gynecology, PGIMER, Chandigarh
- Registration Number
- CTRI/2013/10/004044
- Lead Sponsor
- Council of Scientific and Industrial Research New Delhi India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
Two hundred polycystic ovarian women along with equal number of age matched controls with no evidence of polycystic ovarian syndrome would be enrolled after informed consent from the Infertility clinic at Department of Obstetrics and Gynecology, PGIMER, Chandigarh. Inclusion criteria would include (1) 18-40 years of age, (2) not on any therapy that could influence the metabolic or hepatic biochemical parameters in the last 3 months and (3) willing to participate in the study. While the cases would be women with polycystic ovarian syndrome by Rotterdam or NIH criteria, controls would be all other women fulfilling the inclusion criteria but not having polycystic ovarian syndrome.
Exclusion criteria would include (1) women with other causes of irregular menstruation or androgen excess including hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, premature ovarian failure, cushingâ??s syndrome, androgen secreting tumours (2) history of known liver disease or other medical problems thought to cause elevated liver enzymes (3) history of intake of medication use known to cause an elevation of liver enzymes or (4) history of significant alcohol intake defined as greater than one alcoholic beverage per day.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of NAFLD in Polycystic ovarian women versus women with no polycystic ovarian syndrome in Infertility clinics patients at PGIMER, ChandigarhTimepoint: At enrollment in the trial
- Secondary Outcome Measures
Name Time Method Assessment of the effect of metformin on metabolic, endocrine and hepatic parametersTimepoint: After 3 and 6 months of metformin therapy