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临床试验/CTRI/2025/03/083265
CTRI/2025/03/083265招募中Unknown

An open label, interventional controlled pre-post study of the effects of metformin therapy on insulin resistance and body composition in lean vs.obese PCOS patients

RNT Medical College1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
Unknown
状态
招募中
入组人数
136
试验地点
1
主要终点
Change in insulin resistance indices

研究概览

简要总结

PCOS is one of the most common hormonal disorders in women of reproductive age. Insulin resistance is present in 65-95 %of women with PCOS . Half of PCOS patients are obese and obesity plays a critical role in insulin resistance.half of patients have normal BMI and these lean patients also have increased insulin resistance. Several prospective randomised studies have confirmed positive effects of metformin on metabolic derangements, hyperinsulinemia,hyperandrogenemia, blood pressure and clinical pregnancy rates. However, most of studies are limited to obese patients. Therefore evaluating effects of metformin in lean vs obesePCOS patient’s in longitudinal study is needed to confirm its benefits in lean PCOS patients also. Therefore we want to conduct this study as our hypothesis is metformin will significantly improve insulin resistance indices in both lean and obese patients with greater reduction in obese patients. We will recruit PCOD patients and age and BMI Matched healthy control groups for baseline assessment of insulin resistance and body composition and metabolic parameters.Cases will be divided into two groups of lean PCOS and obese PCOS.Cases will undergo lifestyle intervention and six months of metformin therapy. After 6 months , insulin resistance and body composition parameters will be reassessed. Data will be collected and assessed using SPSS. P value of <0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Phenotypic features of PCOS and fulfilling Rotterdam criteria
  • With written informed consent 3.not on any treatment for last 3 months.

排除标准

  • Secondary causes of oligo-an ovulation 2.h/o intake of drugs in preceding 3 months
  • Pregnancy and lactation
  • Diabetes mellitus
  • Uncontrolled Hypertension 6.not giving consent.

结局指标

主要结局

Change in insulin resistance indices

时间窗: After 6 months

次要结局

  • 1. Change in body composition parameters(2.change in metabolic parameters)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Muskan Jindal

RNT Medical College, Udaipur

研究点 (1)

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