| CTRI Number |
CTRI/2025/01/079478 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Dietary intervention] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Sarcopenic Obesity in PCOS and the Benefits of Personalized Lifestyle Changes for Treatment |
|
Scientific Title of Study
|
Prevalence of Sarcopenic obesity in patients with Polycystic ovary syndrome and efficacy of individualised lifestyle modifications for treatment of Sarcopenic obesity: A Matched Case Control and pre-post intervention study.
|
| 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 Deepali Garg |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 710 MCH AIIMS DELHI
Central
DELHI
110029
India |
| Phone |
9818706660 |
| Fax |
|
| Email |
drdeepaligrag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Garg |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Delhi |
| Address |
Room no. 710 MCH AIIMS DELHI
Central
DELHI
110029
India |
| Phone |
9818706660 |
| Fax |
|
| Email |
drdeepaligrag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Garg |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Delhi |
| Address |
Room no. 710 MCH AIIMS DELHI
Central
DELHI
110029
India |
| Phone |
9818706660 |
| Fax |
|
| Email |
drdeepaligrag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, India, New Delhi - 110029. |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Indian Council of Medical Research, V. Ramalingaswami Bhawan, PO Box No. 4911 Ansari Nagar, New Delhi - 110029 |
| 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 |
| Dr Deepali Garg |
All India Institute of Medical Sciences, New Delhi |
Room no. 9 OPD of Obstetrics and Gynaecology, AIIMS, New Delhi, Sri Aurobindo Marg, Ansari Nagar, New Delhi, Delhi 110029
Central
DELHI |
9818706660
drdeepaligarg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AIIMS, New Delhi |
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 |
Diet and Exercise
|
Duration/Frequency of the proposed intervention: From baseline to 12 weeks
A. Dietary Intervention:
A.1 Diet Type: Low Glycemic Index Diet (LGID)
A.2 Route of Administration: Oral (through guided meal plans and educational counseling)
A.3 Frequency: Daily adherence for 12 weeks
A.4 Duration: From baseline to the end of the 12-week period
B. Exercise Intervention:
B.1 Type: Resistance training exercise
B.2 Frequency: 5 days per week
B.3 Duration: Each session lasting approximately 30–45 minutes over a 12-week period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
a) Inclusion Criteria of cases
o Age 18 to 35 years old, with confirmed clinical diagnosis for PCOS with Rotterdam criteria.
b) Inclusion Criteria of controls
o Healthy females of 18-35 year age with BMI matched with regular menstrual cycles exhibiting no recent changes in menstrual patterns or abnormal elevations in follicle-stimulating hormone [FSH]).
|
|
| ExclusionCriteria |
| Details |
c) Exclusion Criteria
o Pregnant and/or lactating mothers
o Use of hormonal birth control methods or fertility medications during the prior 3 months.
o Women taking anti-seizure or anti-psychotic medications known to induce menstrual irregularity, hypolipidemic agents, antihypertensive medications, or antiaggregant/anticoagulants..
o Any medical history of conditions known to interfere with reproductive or metabolic function (besides PCOS) or bone and muscle metabolism, including diabetes mellitus, hyperprolactinemia, untreated thyroid dysfunction, premature ovarian failure, cushing disease, congenital adrenal hyperplasia, hyperparathyroidism, rheumatoid arthritis, renal disease, chronic obstructive pulmonary disease, and osteoporosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of SO |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The efficacy of individualised lifestyle modifications among sarcopenic obese individuals will be done after repeating the DEXA and the Inflammatory marker hsCRP, insulin resistivity HOMA-IR, lipid profile, levels of HbA1C, vitamin-D levels at 12-weeks post intervention. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/05/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
· Rationale/ gaps in existing knowledge Sarcopenic obesity (SO) is a clinical and functional condition characterized by the coexistence of obesity, characterized by excess fat mass (FM), and sarcopenia (low skeletal muscle mass and function). Sarcopenic obesity is thought to be the consequence of dieting and the cause of weight management problems. SO research in low- and middle- income countries (LMICs) is very limited and comprehensive data on diagnosis and prevalence of SO in India are lacking therefore SO remains largely unsuspected and undiagnosed. · Novelty Despite several common risk factors for sarcopenic obesity and PCOS, the prevalence of SO in women with PCOS is currently not known. Present study is the first study nationally and internationally estimating prevalence of SO in women with PCOS, followed by development of individualised lifestyle modifications modules for treatment of Sarcopenic obesity. · Objectives To compare the proportion of sarcopenic obesity between an age-BMI matched women with PCOS diagnosed using Rotterdam criteria and healthy controls, assessing efficacy of individualised lifestyle modifications for treatment of Sarcopenic obesity. Furthermore, we want to compare the metabolic parameters, markers of inflammation and insulin resistance between SO and non-SO patients. · Methods Seventy 18 to 35 years age women diagnosed with PCOS as cases and 70 age and BMI matched healthy controls will be recruited in the study. Body composition will be assessed once at the time of recruitment using dual-energy X-ray absorptiometry. At baseline metabolic parameters relevant to the study will be done. Nutritional status will be assessed using 24-hour recall method and food frequency questionnaire. After DEXA who come out to be sarcopenic obese will be given individualised lifestyle modifications (low glycaemic index diet with adequate protein as per RDA and resistant exercise training) for treatment of Sarcopenic obesity along with standard treatment. · Expected outcome o Present study will estimate the prevalence of SO in PCOS patients. It will help in developing primary preventive measures and a screening strategy for SO. o Development of dietary and exercise modules specific for management of sarcopenic obesity. o Early detection of SO in PCOS, may help in tackling the long term adverse outcomes of SO like NCDs and may guide the healthcare professionals in the management of PCOS having associated SO, as the treatment regime for SO is quite different as Obesity management strategies should cut fat, not muscle. |