None listed
Conditions
Interventions
Intervention1: Treatment as usual (TAU): Nil
Intervention2: Treatment as usual (TAU) + exercise: 12 Weeks
Intervention3: Treatment as usual (TAU) + controlled diet: 12 Weeks
Intervention4: Treatment a
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 subjectâ??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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Body weightTimepoint: Week 0, Week 4, Week 8, Week 12 & Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: HOMA-IRTimepoint: 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 questionnaireTimepoint: Week 0, Week 4, Week 8, Week 12 & Week 24;Change from baseline to the end of the study period in: Treatment costTimepoint: Week 0, Week 12 & week 24 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar J
Diabetes & Endocrine Clinic
Outcome results
None listed