| CTRI Number |
CTRI/2024/09/073376 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Life Style Modification ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of lifestyle modification in overweight and obese subjects with metabolic syndrome. |
|
Scientific Title of Study
|
A randomized clinical study to evaluate the effect of lifestyle modifications in overweight and obese subjects with metabolic syndrome. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CARE/MetS/LM/24 Version 02, Dated 03-Aug-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Prason Kumar J |
| Designation |
Research Scholar |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of Pharmaceutical Sciences, Room No: 9, Third Floor, Chettinad School of Pharmaceutical Sciences,
Chettinad Hospital and Research Institute,
Kelambakkam, Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9003026444 |
| Fax |
|
| Email |
prasonkumarj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Satyanarayana Murthy |
| Designation |
Senior Consultant |
| Affiliation |
Diabetes & Endocrine Clinic |
| Address |
Department of endocrinology, Room No: 01, Ground Floor, 16/219, Pogathota
Nellore
ANDHRA PRADESH
524001
India |
| Phone |
09849050063 |
| Fax |
|
| Email |
ssatyanarayanamurthy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prason Kumar J |
| Designation |
Research Scholar |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
Department of Pharmaceutical Sciences, Room No: 9, Third Floor, Chettinad School of Pharmaceutical Sciences,
Chettinad Hospital and Research Institute,
Kelambakkam, Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9003026444 |
| Fax |
|
| Email |
prasonkumarj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Diabetes & Endocrine Clinic, 16/219, Pogathota, Nellore, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 S Satyanarayana Murthy |
Diabetes & Endocrine Clinic |
Department of Endocrinology, Division of Endocrinology and Diabetes, Room No: 01, Ground Floor, 16/219, Pogathota
Nellore
ANDHRA PRADESH |
9849050063
ssatyanarayanamurthy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Diabetes & Endocrine Clinic |
No Objection Certificate |
| PCRI Ethics committee |
Approved |
| PCRI Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Metabolic syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treatment as usual (TAU) |
12 Weeks |
| Intervention |
Treatment as usual (TAU) + both exercise & controlled diet |
12 Weeks |
| Intervention |
Treatment as usual (TAU) + controlled diet |
12 Weeks |
| Intervention |
Treatment as usual (TAU) + exercise |
12 Weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged between 20 -70 years with body mass index (BMI) of 25 - 34.9 kg/m2.
2. Subjects with any three of the following five criteria as per Harmonizing the metabolic syndrome- Joint interim statement:
I. Waist Circumference greater than or equal to 90 cm for males and greater than or equal to 80 cm for females.
II. Triglycerides greater than or equal to 150 mg/dL or drug treatment for hyperlipidemia.
III.HDL-C less than 40 mg/dL for males and less than 50 mg/dL for females or drug treatment for low HDL-C.
IV. Systolic blood pressure (SBP) greater than or equal to 130 mm Hg and /or diastolic blood pressure (DBP) greater than or equal to 85 mmHg or drug treatment for hypertension.
V. Fasting plasma glucose greater than or equal to 100 mg/dL or drug treatment for diabetes mellitus.
3. Subjects willing to follow the lifestyle modifications or any other interventions as per study procedure.
4. Subjects agree to maintain the daily dairy and diet tracker.
5. Subject considered generally healthy as per health history and routine clinical investigations during screening.
6. Subjects ready to visit the site for all the assessment visit as per the study.
7. Subjects willing to provide socioeconomic status, physical activity level, education level details.
8. Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
2. Subjects who have any physical or mental disability which could interfere the participation of the study.
3. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
4. History of congestive heart failure or any vascular conditions.
5. Subjects with history of sexually transmitted diseases such as HIV or any other STDs.
6. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
7. Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
8. Subjects consuming alcohol (greater than five drinks per week) and smoking greater than five cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
9. Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
10. Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in
Body weight |
Week 0, Week 4, Week 8, Week 12 & Week 24 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from baseline to the end of the study period in:
HOMA-IR |
Week 0, Week 12 & Week 24 |
Change from baseline to the end of the study period in:
Body mass index
Waist & hip circumference
Fasting blood glucose
Blood pressure
Lipid profile
Atherogenic index of plasma
TyG Index
Perceived stress scale 10
Athens insomnia scale
Quality of life questionnaire |
Week 0, Week 4, Week 8, Week 12 & Week 24 |
Change from baseline to the end of the study period in:
Treatment cost |
Week 0, Week 12 & week 24 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The purpose of this study is to evaluate the effect of lifestyle modification in overweight and obese subjects with metabolic syndrome. A total of 120 male and female subjects of age between 20 and 70 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either TAU or TAU+ exercise, or TAU + controlled diet, or TAU + both exercise & controlled diet at a 1:1:1:1 ratio. The participants will be instructed to take treatment as usual for 12 weeks with the selected lifestyle modifications (diet, exercise, or both), which are limited to specific groups. Apart from primary and secondary outcomes, the study will also record vital signs and adverse events to evaluate the safety. The safety assessment will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
|