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

SLCTR/2008/003


Date of Registration

28 Mar 2008

The date of last modification

Nov 21, 2017


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

DiabRiskSL


Public Acronym

DiabRiskSL


Brief title

None


Universal Trial Number

None


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Single


Purpose

Prevention


Phase


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)

  1. 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

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Secondary outcome(s)

  1. 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

2007-08-16


Anticipated end date

2007-08-16


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

Diabetes Association of Sri Lanka, International Diabetes Federation



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


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
2872951/2883318
0773021666
2872952
dasl@ sltnet.lk

Contact Person for Public Queries

Ms. Laksha Vasantharajah
Ms. Laksha Vasantharajah
National Diabetes Centre, No 50, Sarana Mawatha, Rajagiriya
2872951/2883318

2872952
dasl@sltnet.lk


Primary study sponsor/organization

Diabetes Association of Sri Lanka

No 50, Sarana Mawatha, Rajagiriya
2872951/2883318
2872952
dasl@ sltnet.lk

Secondary study sponsor (If any)

BRIDGES Grant

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


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results