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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 echo­dense 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.

 
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