Identification of risk factors for diabetes, heart and renal disease

• Register: SLCTR
• Last refreshed on: 27 May 2013
• Main ID: SLCTR/2008/003
• Date of registration: 28/03/2008
• 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: 16/8/2007
• 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
• URL: http://www.slctr.lk/trial_details.asp?reg_id={FE3D1D0A-15FE-43AC-95CD-28734E91FE6A}
• Study type: Interventional
• 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

Countries of recruitment

Sri Lanka

Contacts

• Name: Ms. Laksha Vasantharajah
• Affiliation: Research Coordinator

• Name: Dr M A Wijesuriya, MD (Cey),FRCP(Lon),FCCP(Cey)
• Affiliation: Honorary Director – National Diabetes Centre, Secretary – Diabetes Association of Sri Lanka

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Risk factors for cardiovascular disease

Intervention(s)

Behavioral modification leading to life style modification in diet, exercise and stress.
The study group will receive more intensified advice than the control.

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)

None

Source(s) of Monetary Support

Diabetes Association of Sri Lanka

Secondary Sponsor(s)

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