| CTRI Number |
CTRI/2024/10/075834 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [LIFESTYLE INTERVENTION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
IMPACT OF LIFESTYLE TREATMENT IN THE MANAGEMENT OF POLYCYSTIC OVARY SYNDROME (PCOS) |
|
Scientific Title of Study
|
PREVALENCE OF METABOLIC SYNDROME AMONG WOMEN
WITH POLYCYSTIC OVARY SYNDROME (PCOS): IMPACT OF
LIFESTYLE TREATMENT IN THE MANAGEMENT OF
REPRODUCTIVE, ANTHROPOMETRIC, METABOLIC AND
QUALITY OF LIFE FACTORS IN PCOS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Uma Iyer |
| Designation |
Professor |
| Affiliation |
The Maharaja Sayajirao University of Baroda |
| Address |
Department of Foods and Nutrition, Faculty of Family and Community Sciences, The Maharaja Sayajirao University of Baroda
Vadodara
GUJARAT
390002
India |
| Phone |
09824056921 |
| Fax |
|
| Email |
uma.iyer-fn@msubaroda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Uma Iyer |
| Designation |
Professor |
| Affiliation |
The Maharaja Sayajirao University of Baroda |
| Address |
Department of Foods and Nutrition, Faculty of Family and Community Sciences, The Maharaja Sayajirao University of Baroda
Vadodara
GUJARAT
390002
India |
| Phone |
09824056921 |
| Fax |
|
| Email |
uma.iyer-fn@msubaroda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Karamjeet Kaur |
| Designation |
Ph.D. Scholar |
| Affiliation |
The Maharaja Sayajirao University of Baroda |
| Address |
Faculty of Family and Community Sciences, The Maharaja Sayajirao University of Baroda
Vadodara
GUJARAT
390002
India |
| Phone |
8979748289 |
| Fax |
|
| Email |
karamjeet19041996@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission (UGC), Bahadur Shah Zafar Marg, New Delhi, India, 110002 |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
University Grants Commission (UGC) NET Bureau, South Campus of Delhi University, New Delhi- 110021 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Uma Iyer |
Dwarkesh Multispecialty Hospital, Vadodara |
Gynaecology Department, Shivali Society, L & T Circle, VIP Road, Karelibaug, Baroda
Vadodara
GUJARAT |
09824056921
uma.iyer-fn@msubaroda.ac.in |
| Prof Dr Uma Iyer |
MS University Health Centre |
Room 3 and Room 4, Near Rosary School, Opposite M.S.U pavilion, Railway Officers Colony, Pratapgunj, Vadodara, Gujarat, India, 390020
Vadodara
GUJARAT |
9824056921
uma.iyer-fn@msubaroda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research (IECHR) |
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 Treatment and Standard Care |
Women with PCOS will receive interpersonal nutrition counseling for lifestyle modification along with standard care for a duration of 2 months, followed by a 2-month washout period. |
| Comparator Agent |
Standard Care |
The control group will receive only standard care, and at the end of the study (after 4 months), they will be provided with nutritional counseling |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
•Age – 18 to 49 years
•Women with confirmed PCOS (Rotterdam Criteria)
•Women who have attained menarche more than 2 years before the study
•Women who are willing to participate
|
|
| ExclusionCriteria |
| Details |
•Pregnant Women
•Known case of thyroid disorder, cushing’s syndrome, hyperprolactinemia, nonclassic adrenal hyperplasia
•Women on insulin sensitizers
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Homeostasis Model Assessment of Insulin Resistance (HOMA IR 2) |
Baseline: At the beginning of the study
Midpoint: After 2 months of intervention
Follow-up: 2 months after the washout period (4 months from the start of the study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metabolic parameters (Lipid profile, thyroid profile, Hs-CRP, FBS) anthropometric, reproductive, and quality of life |
Baseline: At the beginning of the study
Midpoint: After 2 months of intervention
Follow-up: 2 months after the washout period (4 months from the start of the study) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
06/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to assess the impact of lifestyle treatment on reproductive, anthropometric, metabolic, and quality of life outcomes in women with Polycystic Ovary Syndrome (PCOS). Participants will be recruited from outpatient facilities of selected hospitals in Vadodara, Gujarat, India. Thirty subjects in the experimental group will receive interpersonal nutritional counseling along with standard care for 60 days, followed by a 60-day washout period, while thirty subjects in the control group will receive only standard care. Data on insulin sensitivity (HOMA-IR), lipid profile, hs-CRP, thyroid profile, reproductive factors (menstrual regularity, ovarian morphology), anthropometric measurements (weight, height, waist circumference, hip circumference, waist-to-hip ratio), psychosocial factors (stress, depression, anxiety), quality of life, and lifestyle factors (physical activity, sleep patterns, diet) will be collected at baseline, after 60 days, and after 120 days. The null hypothesis is that lifestyle treatment may not be effective in improving insulin resistance in PCOS subjects, and the trial will be conducted under the supervision of a gynecologist. |