| CTRI Number |
CTRI/2020/10/028473 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [MODERATE INTENSITY EXERCISE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Of Metformin And Exercise On Insulin Resistance In Women With Polycystic Ovary Syndrome |
|
Scientific Title of Study
|
The Impact of metformin Vs moderate intensity exercise on Insulin resistance in women with PCOS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmeet Kaur Bhalla |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research,Chandigarh |
| Address |
DM Senior Resident
Department Of Endocrinology
Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876327236 |
| Fax |
|
| Email |
jaskaurbhalla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pinaki Dutta |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department Of Endocrinology
Post Graduate Institute Of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9357114777 |
| Fax |
|
| Email |
drpinakidutta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pinaki Dutta |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department Of Endocrinology
Post Graduate Institute Of Medical Education And Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9357114777 |
| Fax |
|
| Email |
drpinakidutta12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of Endocrinology
Post Graduate Institute Of Medical Education And Research |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Medical Education And Research |
| Address |
Sector 12, Chandigarh
160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jasmeet Kaur Bhalla |
Post Graduate Institute Of Medical Education And Research, Chandigarh |
Endocrinology Laboratory, Metabolic Clamp Room, Room Number 3024 B,
B Block, 3rd Floor
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH |
9876327236
jaskaurbhalla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Post Graduate Institute Of Medical Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E349||Endocrine disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin
|
Metformin
1 gram twice daily
For four months
|
| Comparator Agent |
Moderate Intensity Exercise |
Walking with 10,000 steps covered over 50 minutes for 3 sessions per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
overweight/obese PCOS women based on Asian BMI classification |
|
| ExclusionCriteria |
| Details |
Diabetes Mellitus
Bleeding Disorders
Hepatic or renal insufficiency
Acute Infection
Chronic Disorders
Use of oral contraceptives/ hormone replacement therapy/insulin sensitizers within the past six weeks
PREGNANCY
H/O CAD/CVA/VTE
SMOKING |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect on insulin resistance |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alterations In Body Mass Index, HOMA -IR, Luteinizing hormone, Follicle stimulating hormone,Testosterone |
4 Months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2020 |
| 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
|
This is a randomized control trial aimed to compare the effect of metformin and moderate intensity exercise on insulin resistance in patients with PCOS. Women between 18-40 years of age who are overweight/obese shall be included for the study after considering the exclusion criteria. At baseline, anthropometry, body composition, hormonal profile and metabolic parameters would be recorded and hyperinsulinemic-euglycemic clamp would be done Thereafter the participants would be randomised into metformin and the exercise group. A 2 week run in period shall be given to the participants to acclimatise to the exercise program and tolerance to metformin shall be assessed. The patients shall be followed at 0, 2 and 4 months. Compliance to the intervention shall be ensured with telephonic calls. At 4 months, metabolic. hormonal profile shall be repeated along with hyperinsulinemic-euglycemic clamp to assess the change in insulin resistance. 12 Healthy, age and BMI matched controls will be taken and a hyperinsulinemic euglycemic clamp would be performed at baseline for comparison.
|