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SLCTR Registration Number
SLCTR/2008/003
Date of Registration
The date of last modification
Aug 05, 2012
View original TRDS
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
None
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
Study 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 begining 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, CRP and fasting insulin levels with calculation of insulin resistance through the HOMA(IR).
This group will be randomly devided 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 upto thew end of three years. The study group will receive intensive intervention through repeated reinforcements of lifestyle modification on a 3 monthly basis.
Both the study and the control groups will recieve a review with FBS and Lipid profile in year 2 and a review similar to the beginging of the study in year 3.
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
â¢Current pregnant state â¢Diabetics or fasting glucose level >= to 126mg/dl or 2 hour value of >= to 200mg/dl â¢Blood pressure ³ 140mm systolic Hgor ³ 90mmHg diastolic or on treatment for hypertension â¢On treatment for dyslipidaemia Ischemic heart disease (angina, MI, angioplasty,CABG), stroke â¢Diagnosed nephropathy or 50% reduction of initial estimated glomerular filtration rate (EGFR) in subsequent analysis
Primary outcome(s)
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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)
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1.
Subjective: Improvement in diet, exercise Objective: BMI and waist In the study group once in 3 months and control group once a year |
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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
2012-08-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Diabetes Association of Sri Lanka
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
| Name: | |
| Institutional Address: | |
| Telephone: | |
| Email: |
Contact person for Scientific Queries/Principal Investigator
Dr M A Wijesuriya, MD (Cey),FRCP(Lon),FCCP(Cey)
Honorary Director â National Diabetes Centre, Secretary â 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
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
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
