Diabetes Prevention Study Sri Lanka

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2008/001
• Date of registration: 28/03/2008
• Primary sponsor: National Sceince Foundation
• Public title: Diabetes Prevention Study Sri Lanka
• Scientific title: To evaluate the effectiveness of a lifestyle intervention package aimed at primary prevention of type 2 diabetes mellitus (T2DM) among subjects with impaired fasting glucose (IFG-100 to 125 mg/ dl) in a rural population of Gampaha district.
• Date of first enrolment: 1/10/2006
• Target sample size: 185
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={85DAFD3C-A387-4547-843F-D8C1E6FB7290}
• Study type: Interventional
• Study design: Experimental study (cluster-randomized trial) to evaluate the effectiveness of the lifestyle intervention package in primary prevention of diabetes among subjects with IFG state.

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr R.P.P Karunapema
• Affiliation: Senior Registrar in Community Medicine

• Name: Dr R.P.P Karunapema
• Affiliation: Registrar in Community Medicine

Key inclusion & exclusion criteria

Inclusion criteria: Adults 30 to 59 years with IFG state (100 – 125 mg/dl fasting plasma glucose)
Exclusion criteria: Summary of the exclusion criteria (Annex 13)
1.Diabetes at baseline evaluatio (or past history )
2.Other diseases affecting the subjects, which limit the participation in a lifestyle intervention
3.Disease associated with disordered glucose metabolism
4.Exclusions related to medications
5.Pregnancy / planning a pregnancy within the next six months
6.Excessive alcohol intake, either acute or chronic -Defined as average consumption of three or more alcohol drinks daily

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Diabetes primary prevention

Intervention(s)

The intervention group received the lifestyle intervention package while the control group received a brief advice. Duration of the study was six-months

Primary Outcome(s)

·Fasting plasma glucose
·Fasting serum insulin(FSI)
·Conversion to normoglycemic state
·Conversion to diabetes

Secondary Outcome(s)

•Serum lipids
•Blood pressure
•Weight, BMI, waist circumference, hip circumference and waist / hip ratio
•Physical activity
•Dietary intake of selected macronutrients and energy
•Smoking and alcohol consumption

Secondary ID(s)

None

Source(s) of Monetary Support

National Sceince Foundation,Sri Lanka

Secondary Sponsor(s)

Dr A. Pathmeswaran