Diabetes, hypertension, dyslipideamia, overweight/ obesity, metabolic syndrome and cardiovascular diseases
Conditions
Interventions
The trial will be conducted in 3 arms:
(A) Control arm with routine care
(B) Intervention arm 1 with diet and lifestyle modification counselling
(C) Intervention arm 2 with diet and lifestyle modifica
Sponsors
University of Colombo
Peers for Progress organization, USA, coordinated by Monash University, Austrailia ,
Eligibility
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of metabolic syndrome in 15 % in the study population. [At baseline and at six months] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in composite CVD risk score, based on Framingham risk score [Biochemical parameters to be assessed at pre and post intervention ( 6 months apart) All other assessments at baseline and every 2 months until the end of the intervention period (6 months) ] Change in BMI, waist circumference, mean systolic blood pressure/mean diastolic blood pressure, [ ] Change in Fasting Blood Glucose, Low Density Lipoprotein, Triglycerides levels [ ] Smoking: reduction in the number of pack years and reduction of percentage of current smokers, [ ] Increase in number of portions of fruit and vegetables eaten , reduction in intake of refined carbohydrates, reduction of saturated fats and total fat intake, reduction of salt intake, reduction of sugar intake (Food Frequency Questionnaire) [ ] Improvement in physical activity levels (in MET Equivalents using the general Physical Activity Questionnaire) [ ] Improvement in knowledge, attitudes and practices regarding CVD risk and their risk factors (KAP Questionnaire) Comment Education through Activity booklet and advices for improvement during intervention [ ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. P.A. de Silva
Senior Lecturer
Outcome results
None listed