CTRI Number |
CTRI/2020/10/028331 [Registered on: 09/10/2020] Trial Registered Prospectively |
Last Modified On: |
05/10/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Other (Specify) [Lifestyle Modification] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial to study the effect of exercise and metformin on mitochondrial health in patients with polycystic ovarian syndrome (PCOS) |
Scientific Title of Study
|
To assess the efficacy of moderate-intensity exercise training and metformin on mitophagy and mitochondrial phenotype in patients with polycystic ovarian syndrome (PCOS) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shipra Bhansali |
Designation |
Young Scientist |
Affiliation |
PGIMER |
Address |
Department of Endocrinology PostGraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
9988582272 |
Fax |
|
Email |
bhansalishipra@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pinaki Dutta |
Designation |
Professor |
Affiliation |
PGIMER |
Address |
Department of Endocrinology PostGraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
9357114777 |
Fax |
|
Email |
pinaki_dutta@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shipra Bhansali |
Designation |
Young Scientist |
Affiliation |
PGIMER |
Address |
Department of Endocrinology PostGraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
Chandigarh CHANDIGARH 160012 India |
Phone |
9988582272 |
Fax |
|
Email |
bhansalishipra@gmail.com |
|
Source of Monetary or Material Support
|
Department of Health Research (DHR),New Delhi-110001
|
|
Primary Sponsor
|
Name |
DHR |
Address |
Department of Health Research,
2nd Floor, IRCS Building
1, Red Cross Road, New Delhi-110001
|
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Pinaki Dutta |
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, INDIA |
New OPD Block, Outdoor Patient Clinic (OPD),Room No. 4020, Dept of Endocrinology, Post Graduate Institute of Medical Education and Research (PGIMER), Sector-12, Chandigarh Chandigarh CHANDIGARH |
9357114777
pinaki_dutta@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutes Ethics Committee, PGIMER, Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Lifestyle Modification |
Moderate-intensity exercise (brisk walking), 3 sessions per week (50 mins each) |
Intervention |
Metformin |
Metformin Oral Administration 1000mg twice a day |
Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
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).
|
|
ExclusionCriteria |
Details |
•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
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
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
|
Outcome |
TimePoints |
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 |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
12/10/2020 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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. |