A clinical trial to study the effect of exercise and metformin on mitochondrial health in patients with polycystic ovarian syndrome (PCOS)

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028331

Enrollment

Registered

2020-10-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Metformin: Metformin Oral Administration 1000mg twice a day Intervention2: Lifestyle Modification: Moderate-intensity exercise (brisk walking), 3 sessions per week (50 mins each) Contro

Eligibility

Inclusion criteria

Inclusion criteria: 1.PCOS patients with a BMI of more than 25 kg/mÂ² 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).

Exclusion criteria

Exclusion criteria: •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

Design outcomes

Primary

Measure	Time frame
Changes in mitophagy, mitochondrial mass, and function with PCOS-related symptoms (ovulation cycle, hirsutism score, androgen levels and ovarian morphology) Timepoint: At baseline and after 4 months	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Shipra Bhansali

PGIMER

pinaki_dutta@hotmail.com9357114777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026