A clinical trial to study the effect of exercise and metformin on mitochondrial health in patients with polycystic ovarian syndrome (PCOS)
- Conditions
- Polycystic ovarian syndrome,
- Registration Number
- CTRI/2020/10/028331
- Lead Sponsor
- DHR
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 36
- 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 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) At baseline and after 4 months
- 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-Beta At baseline and after 4 months
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, INDIA
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, INDIA🇮🇳Chandigarh, CHANDIGARH, IndiaDr Pinaki DuttaPrincipal investigator9357114777pinaki_dutta@hotmail.com