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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 13 January 2020
Main ID:  SLCTR/2008/003
Date of registration: 2008-03-28
Prospective Registration: No
Primary sponsor: Diabetes Association of Sri Lanka
Public title: Identification of risk factors for diabetes, heart and renal disease
Scientific title: Evaluation of risk factors in the development of type 2 diabetes and cardiovascular disease in a young urban population in Sri Lanka
Date of first enrolment: 2007-08-16
Target 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.
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Randomized controlled trial  
Phase:  Not Available
Countries of recruitment
Sri Lanka
Name: Ms. Laksha Vasantharajah    
Address:  National Diabetes Centre, No 50, Sarana Mawatha, Rajagiriya
Telephone: 2872951/2883318
Affiliation:  Ms. Laksha Vasantharajah
Name: Dr M A Wijesuriya, MD (Cey),FRCP(Lon),FCCP(Cey)    
Address:  No 50, Sarana Mawatha, Rajagiriya
Telephone: 2872951/2883318
Email: dasl@
Affiliation:  Honorary Director – National Diabetes Centre, Secretary – Diabetes Association of Sri Lanka
Key inclusion & exclusion criteria
Inclusion criteria: Age between 5-40 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 91st 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

Age minimum:
Age maximum:
Health Condition(s) or Problem(s) studied
Risk factors for cardiovascular disease
Approximately 25,000 persons between 10-40 years of age from schools, universities and workplaces will be screened by a simple questionnaire sand 5000 with two or more risk factors will be selected for further study and follow up.

at the beginning of the study the biochemical and a physical examination will be performed on these persons. This includes FBs, 2 hour OGTT, Lipid profile, serum creatinine, Albumin Creatinine Ratio (ACR), CRP and fasting insulin levels with calculation of insulin resistance through the HOMA(IR).

This group will be randomly divided i(using simple randomization method in SPSS version 13) into a control and a study group. The control group will receive general advice on lifestyle modification and will be reviewed annually up to the end of three years. The study group will receive intensive intervention through repeated reinforcements of lifestyle modification on a 3 monthly basis. In addition, random blood sugar and blood pressure will be measured.

Both the study and the control groups will receive a review with FBS, OGTT and Lipid profile in year 2 and a review similar to the beginning of the study in year 3. For high ACR a repeat measure will be done and if persistently high, referred to a nephrologist and excluded from the study. Those will high OGTT will have a repeat test and if persistently high, referred to a doctor and excluded from the study.
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 []
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 ID(s)
Source(s) of Monetary Support
Diabetes Association of Sri Lanka, International Diabetes Federation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Ethics Review Committee, Sri Lanka Medical Association,
No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka
Results available:
Date Posted:
Date Completed:
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