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临床试验/CTRI/2024/10/075834
CTRI/2024/10/075834尚未招募1 期

PREVALENCE OF METABOLIC SYNDROME AMONG WOMEN WITH POLYCYSTIC OVARY SYNDROME (PCOS): IMPACT OF LIFESTYLE TREATMENT IN THE MANAGEMENT OF REPRODUCTIVE, ANTHROPOMETRIC, METABOLIC AND QUALITY OF LIFE FACTORS IN PCOS

University Grants Commission2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月6日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Homeostasis Model Assessment of Insulin Resistance (HOMA IR 2)

研究概览

简要总结

This randomized controlled trial aims to assess the impact of lifestyle treatment on reproductive, anthropometric, metabolic, and quality of life outcomes in women with Polycystic Ovary Syndrome (PCOS). Participants will be recruited from outpatient facilities of selected hospitals in Vadodara, Gujarat, India. Thirty subjects in the experimental group will receive interpersonal nutritional counseling along with standard care for 60 days, followed by a 60-day washout period, while thirty subjects in the control group will receive only standard care. Data on insulin sensitivity (HOMA-IR), lipid profile, hs-CRP, thyroid profile, reproductive factors (menstrual regularity, ovarian morphology), anthropometric measurements (weight, height, waist circumference, hip circumference, waist-to-hip ratio), psychosocial factors (stress, depression, anxiety), quality of life, and lifestyle factors (physical activity, sleep patterns, diet) will be collected at baseline, after 60 days, and after 120 days. The null hypothesis is that lifestyle treatment may not be effective in improving insulin resistance in PCOS subjects, and the trial will be conducted under the supervision of a gynecologist.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
Female

入选标准

  • •Age – 18 to 49 years •Women with confirmed PCOS (Rotterdam Criteria) •Women who have attained menarche more than 2 years before the study •Women who are willing to participate.

排除标准

  • •Pregnant Women •Known case of thyroid disorder, cushing’s syndrome, hyperprolactinemia, nonclassic adrenal hyperplasia •Women on insulin sensitizers.

结局指标

主要结局

Homeostasis Model Assessment of Insulin Resistance (HOMA IR 2)

时间窗: Baseline: At the beginning of the study | Midpoint: After 2 months of intervention | Follow-up: 2 months after the washout period (4 months from the start of the study)

次要结局

  • Metabolic parameters (Lipid profile, thyroid profile, Hs-CRP, FBS) anthropometric, reproductive, and quality of life(Baseline: At the beginning of the study)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Prof Dr Uma Iyer

The Maharaja Sayajirao University of Baroda

研究点 (2)

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