跳至主要内容
临床试验/CTRI/2020/10/028331
CTRI/2020/10/028331尚未招募4 期

To assess the efficacy of moderate-intensity exercise training and metformin on mitophagy and mitochondrial phenotype in patients with polycystic ovarian syndrome (PCOS)

DHR1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年12月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
DHR
入组人数
36
试验地点
1
主要终点
Changes in mitophagy, mitochondrial mass, and function with PCOS-related symptoms (ovulation cycle, hirsutism score, androgen levels and ovarian morphology)

研究概览

简要总结

Polycystic ovarian syndrome (PCOS) is the most common reproductive-endocrine disorder occurring in the young women of age group 15-45 years. These women usually present with menstrual irregularities, excessive facial hair growth, acne, infertility and rarely with baldness. Majority of the women with PCOS are obese, exhibit insulin resistance resulting in elevated levels of insulin (hyperinsulinemia), which is a key abnormality in these patients. Hyperinsulinemia results in the overproduction of androgens and subsequently leads to clinical manifestation of  PCOS, accompanied with formation of multiple cysts in the ovaries. Exercise and metformin are commonly recommended therapies for the management of PCOS, as these women display high degree of insulin resistance, and are also predisposed to develop prediabetes and diabetes. The investigators are conducting this research to explore that how exercise and metformin affects the cellular health in patients with PCOS, specifically mitophagy and mitochondrial health. Previous studies have reported the role of mitochondrial dysfunction in insulin resistance. Mitophagy involves the removal of damaged mitochondria and cellular debris, which improves cell survival and function, as mitochondria are the powerhouse of the cell. The investigators would like to explore that whether there is any association between mitophagy and mitochondrial function with symptoms of PCOS before and after exercise and metformin intervention at the transcriptional and translational level.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.PCOS patients with a BMI of more than 25 kg/m² 2.Oligo/amenorrhoea: Absence of menstruation more than 35 days and/or less than 8 menses per year or no menses for consecutive 6 months.
  • 3.Hyperandrogenism: i)Clinical (hirsutism or less commonly male pattern alopecia): Modified Ferriman and Gallwey score of 6 or higher.
  • ii)Biochemical hyperandrogenism iii)Polycystic ovarian morphology: Presence of more than 12 cysts, 2–8 mm in diameter, usually combined with increased ovarian volume of more than 10 cm3, and an echo­dense stroma in the pelvic ultrasound scan (transducer frequency less than 8 mHz).

排除标准

  • •Smokers •Patients with diabetes mellitus or any other endocrine disorder •Bleeding disorders, hepatic or renal insufficiency •Patients with any acute infection or chronic disease •Patients on oral contraceptives or hormonal replacement therapy (HRT) or other insulin-sensitizing agents within previous 6 weeks •Pregnancy •Patients with history of ischaemic heart disease, stroke or thromboembolism.

结局指标

主要结局

Changes in mitophagy, mitochondrial mass, and function with PCOS-related symptoms (ovulation cycle, hirsutism score, androgen levels and ovarian morphology)

时间窗: At baseline and after 4 months

次要结局

  • Alterations in anthropometric parameters (weight, BMI, waist circumference), signs of insulin resistance, metabolic parameters including FPG, PPG, HOMA-IR and HOMA-Beta(At baseline and after 4 months)

研究者

发起方
DHR
申办方类型
Government funding agency

研究点 (1)

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