| Scientific Title of Trial | Evaluation of risk factors in the development of type 2 diabetes and cardiovascular disease in a young urban population in Sri Lanka | |
| Public Title of Trial (in lay language) | Identification of risk factors for diabetes, heart and renal disease | |
| Acronym, if any | DiabRiskSL | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Risk factors for cardiovascular disease | |
| What is the research question being addressed? | primary prevention of diabetes and cardio-renal disease through non pharmacological lifestyle intervention ? | |
| Study design | •Type of study -interventional •Study design - Allocation randomized controlled trial - Masking open (masking not used) -Control active - Assignment single -Purpose prevention • Phase N/A | |
| Intervention(s) planned | Behavioral modification leading to life style modification in diet, exercise and stress. The study group will receive more intensified advice than the control. | |
| Inclusion criteria | Age between 10-40 years Voluntary participation or parental written consent Two or more of the following 4 criteria 1. First degree family history of diabetes : Father, mother, brother, sister son or a daughter 2. Physical inactivity-Physical activity/exercises less than 30 minutes continuous per day for less than 3 days a week 3. Body Mass Index (BMI): In 10 to 11 year olds defined as weight for height over the 85th percentile and above 11 years to 16 years the BMI over 85th percentile and above 16 years BMI = 23kg/m2 4. Waist -10-16 years: equal or above 90th percentile (or adult cutoff if lower) and above 16 years: Waist of females ³ 80cm of males 90cm | |
| Exclusion criteria | •Current pregnant state •Diabetics or fasting glucose level >= to 126mg/dl or 2 hour value of >= to 200mg/dl •Blood pressure ³ 140mm systolic Hgor ³ 90mmHg diastolic or on treatment for hypertension •On treatment for dyslipidaemia Ischemic heart disease (angina, MI, angioplasty,CABG), stroke •Diagnosed nephropathy or 50% reduction of initial estimated glomerular filtration rate (EGFR) in subsequent analysis | |
| Target number / sample size | Maximum of 25,000 persons to be screened to find 5,000 risk individuals. If the 5,000 target achieved before the first stage will end in less than 25,000. | |
| Primary outcome(s) | The development of Diabetes, Hypertension, Dyslipidaemia needing treatment, Ischaemic heart disease and Reduced e-GFR up to 50% in subsequent analysis in the study and the control group | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | Subjective: Improvement in diet, exercise Objective: BMI and waist In the study group once in 3 months and control group once a year | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 16/08/2007 | |
| Anticipated end date | 01/08/2012 | |
| Recruitment status | Current | |
| State of ethics review approval | Approved by Ethical Review Committee of Sri Lanka Medical Association | |
| Funding source(s) | Diabetes Association of Sri Lanka | |
| Applicant's Email | dasl@sltnet.lk | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr M A Wijesuriya, MD (Cey),FRCP(Lon),FCCP(Cey)
Honorary Director – National Diabetes Centre, Secretary – Diabetes Association of Sri Lanka No 50, Sarana Mawatha, Rajagiriya 2872951/2883318 /0773021666 2872952 dasl@ sltnet.lk |
|
| Primary Study Sponsor/ Organization | Diabetes Association of Sri Lanka
No 50, Sarana Mawatha, Rajagiriya Tel 2872951/2883318 2872952 dasl@ sltnet.lk |
|
| Contact Person for Public Queries | Ms. Laksha Vasantharajah Research Coordinator National Diabetes Centre, No 50, Sarana Mawatha, Rajagiriya 2872951/2883318 2872952 dasl@sltnet.lk |
|
| Secondary Study Sponsor(s), (if any) | This project is supported by a BRIDGES Grant from the International Diabetes Federation.BRIDGES, is a project, supported by an educationalgrant from Eli Lilly and Company to the International Diabetes Federation |
|
