Non alcoholic fatty liver disease in Polycystic ovarian syndrome in Indian women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Prevalence of NAFLD in Polycystic ovarian women versus women with no polycystic ovarian syndrome in Infertility clinics patients at PGIMER, Chandigarh
研究概览
简要总结
There is growing evidence that polycystic ovarian syndrome is associated with non-alcoholic fatty liver disease (NAFLD) in women (Baranova et al 2011). Dietary and lifestyle changes have therapeutic value in improving both the metabolic as well as gynaecological profile of polycystic ovarian women (Angulo 2002; Brown 2005; Setji 2005). Medical interventions used in polycystic ovarian syndrome include metformin, insulin sensitizing drugs and ovulation induction drugs. While metformin and other insulin sensitizing drugs are being studied for their effect on the NAFLD status (Socha 2009), more studies are required to document the need and effect of these drugs in the early prevention of metabolic syndrome. Non alcoholic fatty liver disease (NAFLD) and its associated effects in polycystic ovarian women. The first part of this study is a case control study comparing the metabolic biochemical parameters and radiological evidence of non alcoholic fatty liver disease in obese and lean polycystic ovarian women (n=215) and matched controls with no evidence of PCOS (n=215). The second part would be a randomised clinical trial to compare the effect of metformin with dietary modifications and lifestyle changes versus placebo with dietary modifications and lifestyle changes on metabolic biochemical parameters, radiological parameters of non alcoholic fatty liver disease, endocrine parameters, ovulation and pregnancy rates of obese versus lean polycystic ovarian syndrome women with evidence of Non alcoholic fatty liver disease. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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, cushing’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.
结局指标
主要结局
Prevalence of NAFLD in Polycystic ovarian women versus women with no polycystic ovarian syndrome in Infertility clinics patients at PGIMER, Chandigarh
时间窗: At enrollment in the trial
次要结局
- Assessment of the effect of metformin on metabolic, endocrine and hepatic parameters(After 3 and 6 months of metformin therapy)