| CTRI Number |
CTRI/2025/03/083265 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To study the effects of metformin therapy on insulin resistance and body composition in lean vs.obese PCOS patients |
|
Scientific Title of Study
|
An open label, interventional controlled pre-post study of the effects of metformin therapy on insulin resistance and body composition in lean vs.obese PCOS patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Muskan Jindal |
| Designation |
DM Student |
| Affiliation |
RNT Medical College, Udaipur |
| Address |
Senior Resident,
Department of Endocrinology,
SSH and RNT Medical college,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9780431458 |
| Fax |
|
| Email |
Drmuskanjindal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kansara |
| Designation |
Professor and Head of department |
| Affiliation |
RNT Medical college, Udaipur |
| Address |
Department of Endocrinology,
RNT Medical college,
Udipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9352241126 |
| Fax |
|
| Email |
Drsandeepkansara@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mona Sood |
| Designation |
Assistant Professor |
| Affiliation |
RNT Medical college, Udaipur |
| Address |
Department of Endocrinology,
SSH and RNT Medical College,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9311478758 |
| Fax |
|
| Email |
Drmona87@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| RNT Medical College, Udaipur, Rajasthan, India
PIN code 313001 |
|
|
Primary Sponsor
|
| Name |
RNT Medical College |
| Address |
Near Court Chownk , Udaipur, Rajasthan, India
PIN code 313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Muskan Jindal |
RNT Medical College, Udaipur |
Department of Endocrinology, Third floor , Superspeciality Hospital
Udaipur
RAJASTHAN |
9780431458
Drmuskanjindal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
Drug therapy |
Comparison of efficacy of 6 months of metformin therapy in lean vs obese PCOS patients |
| Comparator Agent |
Metformin |
Comparison of efficacy of 6 months metformin therapy in lean vs obese PCOS patients on insulin resistance and body composition parameters |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Phenotypic features of PCOS and fulfilling Rotterdam criteria
2. With written informed consent
3.not on any treatment for last 3 months |
|
| ExclusionCriteria |
| Details |
1. Secondary causes of oligo-an ovulation
2.h/o intake of drugs in preceding 3 months
3. Pregnancy and lactation
4. Diabetes mellitus
5. Uncontrolled Hypertension
6.not giving consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in insulin resistance indices |
After 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in body composition parameters
2.change in metabolic parameters
3.change in hormonal parameters
4.regularisation of menstrual cycle
5. Change in clinical signs of hyperandrogenism |
After 6 months |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PCOS is one of the most common hormonal disorders in women of reproductive age. Insulin resistance is present in 65-95 %of women with PCOS . Half of PCOS patients are obese and obesity plays a critical role in insulin resistance.half of patients have normal BMI and these lean patients also have increased insulin resistance. Several prospective randomised studies have confirmed positive effects of metformin on metabolic derangements, hyperinsulinemia,hyperandrogenemia, blood pressure and clinical pregnancy rates. However, most of studies are limited to obese patients. Therefore evaluating effects of metformin in lean vs obesePCOS patient’s in longitudinal study is needed to confirm its benefits in lean PCOS patients also. Therefore we want to conduct this study as our hypothesis is metformin will significantly improve insulin resistance indices in both lean and obese patients with greater reduction in obese patients. We will recruit PCOD patients and age and BMI Matched healthy control groups for baseline assessment of insulin resistance and body composition and metabolic parameters.Cases will be divided into two groups of lean PCOS and obese PCOS.Cases will undergo lifestyle intervention and six months of metformin therapy. After 6 months , insulin resistance and body composition parameters will be reassessed. Data will be collected and assessed using SPSS. P value of <0.05 will be considered significant. |