ifestyle change programme for reduction of cardiovascular risk

Not Applicable

• Conditions: Diabetes, hypertension, dyslipideamia, overweight/ obesity, metabolic syndrome and cardiovascular diseases

• Registration Number: SLCTR/2013/002
• Lead Sponsor: niversity of Colombo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Participant characteristics: • 35-55 year old males and females • free living -- non- institutionalized • residents of Colombo district • attending the medical clinics at NHSL • with metabolic syndrome (1) Raised Triglycerides >150 mg/l (1.7 mmol/l) or specific treatment for hypertriglyceridaemia. (2) Low HDL-cholesterol <40 mg/l (1.03 mmol/l) in males and <50 mg/l (1.29 mmol/l) in females or specific treatment for low HDL-cholesterol. (3) Raised blood pressure: systolic blood pressure >130 mmHg or diastolic blood pressure >85 mmHg or treatment for previously diagnosed hypertension. (4) Dysglycaemia: fasting plasma glucose>100 mg/l (5.6 mmol/l) and/or 2 h post-oral glucose tolerance test glucose >7.8 mmol/l or previously diagnosed type-2 diabetes. (5) Central obesity - classified as waist circumference >90 cm for males and >80 cm for females Presence of central obesity together with any two of the above (1-4) parameters are defined to have metabolic syndrome. • The following parameters diagnosed within 5 years of duration - elevated blood glucose levels, elevated blood pressure, dyslipideamia Comment 1) Participants must have all of these conditions. 2) The participants are randomized. Therefore we assume the participants who have variations among the presence of the parameters of metabolic syndrome are equally distributed 3) Also even there are changes in these diseases which are considered as cardiovascular risk factors, modification of diet and exercise which can be practiced in clinic setup is more or less same. 4) Since we are studying the overall cardiovascular risk, minor differences will not be of major significance. 5) Individual conditions are not considered as outcome indicators.

Exclusion Criteria

Patients who are having • CVD events – Ischemic heart diseases, • past history of hospitalization due to CVDs, • renal dysfunction (Acute or Chronic renal failure) • Chronic diseases, • pregnant & lactating or planning for pregnancy, • non ambulatory to be excluded by interviewing & examination of clinic records

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of metabolic syndrome in 15 % in the study population. [At baseline and at six months]<br>