A clinical trial to study the effect of exercise and metformin on mitochondrial health in patients with polycystic ovarian syndrome (PCOS)
- Conditions
- Health Condition 1: E282- Polycystic ovarian syndrome
- Registration Number
- CTRI/2020/10/028331
- Lead Sponsor
- DHR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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, 2â??8 mm in diameter, usually combined with increased ovarian volume of more than 10 cm3, and an echoÂdense stroma in the pelvic ultrasound scan (transducer frequency less than 8 mHz).
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in mitophagy, mitochondrial mass, and function with PCOS-related symptoms (ovulation cycle, hirsutism score, androgen levels and ovarian morphology) <br/ ><br>Timepoint: At baseline and after 4 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Alterations in anthropometric parameters (weight, BMI, waist circumference), signs of insulin resistance, metabolic parameters including FPG, PPG, HOMA-IR and HOMA-BetaTimepoint: At baseline and after 4 months