| CTRI Number |
CTRI/2013/10/004044 [Registered on: 03/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Fatty liver disease in Polycystic ovarian syndrome Indian women |
|
Scientific Title of Study
|
Non alcoholic fatty liver disease in Polycystic ovarian syndrome in Indian women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujata Siwatch |
| Designation |
Senior Research Associate |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Obstetrics and Gynecology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
siwatch1@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakhbir Kaur Dhaliwal |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Obstetrics and Gynecology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
dhaliwalgynae.pgimer@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujata Siwatch |
| Designation |
Senior Research Associate |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Obstetrics and Gynecology, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
siwatch1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| CSIR, Pusa Road, New Delhi |
|
|
Primary Sponsor
|
| Name |
Council of Scientific and Industrial Research New Delhi India |
| Address |
CSIR, Pusa Road, New Delhi |
| 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 |
| Sujata Siwatch |
Deptt of Obstetrics and Gynecology, PGIMER, Chandigarh |
Obstetrics and Gynecology, PGIMER, Sector-12, Chandigarh
Chandigarh
CHANDIGARH |
0172-2756331
siwatch1@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Infertility patients attending the outpatient infertility clinic at Department of Obstetrics and gynecology, PGIMER, Chandigarh, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metformin 500mg tds for 6 months |
In the second part of the study, half of the NAFLD women from PCOS patients would be randomised to receive metformin |
| Comparator Agent |
Placebo thrice a day for 6 months |
In the second part of the study, half the NAFLD affected PCOS women would be randomised to receive placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Two hundred polycystic ovarian women along with equal number of age matched controls with no evidence of polycystic ovarian syndrome would be enrolled after informed consent from the Infertility clinic at Department of Obstetrics and Gynecology, PGIMER, Chandigarh. Inclusion criteria would include (1) 18-40 years of age, (2) not on any therapy that could influence the metabolic or hepatic biochemical parameters in the last 3 months and (3) willing to participate in the study. While the cases would be women with polycystic ovarian syndrome by Rotterdam or NIH criteria, controls would be all other women fulfilling the inclusion criteria but not having polycystic ovarian syndrome. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria would include (1) women with other causes of irregular menstruation or androgen excess including hyperprolactinemia, uncontrolled thyroid disease, congenital adrenal hyperplasia, premature ovarian failure, cushing’s syndrome, androgen secreting tumours (2) history of known liver disease or other medical problems thought to cause elevated liver enzymes (3) history of intake of medication use known to cause an elevation of liver enzymes or (4) history of significant alcohol intake defined as greater than one alcoholic beverage per day. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of NAFLD in Polycystic ovarian women versus women with no polycystic ovarian syndrome in Infertility clinics patients at PGIMER, Chandigarh |
At enrollment in the trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the effect of metformin on metabolic, endocrine and hepatic parameters |
After 3 and 6 months of metformin therapy |
|
|
Target Sample Size
|
Total Sample Size="430"
Sample Size from India="430"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="210" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2012 |
| Date of Study Completion (India) |
18/09/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There is growing evidence that polycystic ovarian syndrome is associated with non-alcoholic fatty liver disease (NAFLD) in women (Baranova et al 2011). Dietary and lifestyle changes have therapeutic value in improving both the metabolic as well as gynaecological profile of polycystic ovarian women (Angulo 2002; Brown 2005; Setji 2005). Medical interventions used in polycystic ovarian syndrome include metformin, insulin sensitizing drugs and ovulation induction drugs. While metformin and other insulin sensitizing drugs are being studied for their effect on the NAFLD status (Socha 2009), more studies are required to document the need and effect of these drugs in the early prevention of metabolic syndrome. Non alcoholic fatty liver disease (NAFLD) and its associated effects in polycystic ovarian women. The first part of this study is a case control study comparing the metabolic biochemical parameters and radiological evidence of non alcoholic fatty liver disease in obese and lean polycystic ovarian women (n=215) and matched controls with no evidence of PCOS (n=215). The second part would be a randomised clinical trial to compare the effect of metformin with dietary modifications and lifestyle changes versus placebo with dietary modifications and lifestyle changes on metabolic biochemical parameters, radiological parameters of non alcoholic fatty liver disease, endocrine parameters, ovulation and pregnancy rates of obese versus lean polycystic ovarian syndrome women with evidence of Non alcoholic fatty liver disease. |