Home » Trials » SLCTR/2008/003

Evaluation of risk factors in the development of type 2 diabetes and cardiovascular disease in a young urban population in Sri Lanka


SLCTR Registration Number


Date of Registration

28 Mar 2008

The date of last modification

Mar 03, 2019

View original TRDS

Trial Status

Application Summary

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

Identification of risk factors for diabetes, heart and renal disease

Disease or Health Condition(s) Studied

Risk factors for cardiovascular disease

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

ERC 07-010 (Ethics Review Committee of the Sri Lanka Medical Association)

Trial Details

What is the research question being addressed?

Primary prevention of diabetes and cardio-renal disease through non pharmacological lifestyle intervention

Type of study


Study design


Randomized controlled trial


Masking not used







Study Phase

Not Available

Intervention(s) planned

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.

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

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


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.

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Diabetes Association of Sri Lanka, International Diabetes Federation

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee, Sri Lanka Medical Association,
Institutional Address:No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka
Email: erc.slma@gmail.com

Contact & Sponsor Information

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
dasl@ sltnet.lk

Contact Person for Public Queries

Ms. Laksha Vasantharajah
Ms. Laksha Vasantharajah
National Diabetes Centre, No 50, Sarana Mawatha, Rajagiriya


Primary study sponsor/organization

Diabetes Association of Sri Lanka

No 50, Sarana Mawatha, Rajagiriya
dasl@ sltnet.lk

Secondary study sponsor (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

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not Available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results