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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. -

SLCTR Registration Number

SLCTR/2008/001


Date of Registration

21 Jan 2008

The date of last modification

Nov 21, 2017


Trial Status



Application Summary


Scientific Title of Trial

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.


Public Title of Trial

Diabetes Prevention Study Sri Lanka


Disease of Health Condition(s) Studied

Diabetes primary prevention


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


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

P5/03/2006 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)


Trial Details


What is the research question being addressed?

This study was designed considering the lack of information in relation to the primary prevention of diabetes among IFG subjects , especially in a developing country ?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose


Intervention(s) planned

Experimental study (cluster-randomized trial) to evaluate the effectiveness of the lifestyle intervention package in primary prevention of diabetes among subjects with IFG state. The intervention group received the lifestyle intervention package while the control group received a brief advice. Duration of the study was six-months


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



Primary outcome(s)

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


Primary outcome(s) - Time of assessment(s)


Secondary outcome

•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 outcome(s) - Time of assessment(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



Target number/sample size

185


Countries of recruitment

Sri Lanka


Anticipated start date

2006-10-01


Anticipated end date

2009-10-01


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya (P5/03/2006)


Funding source

National Sceince Foundation,Sri Lanka



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr R.P.P Karunapema
Senior Registrar in Community Medicine
253 , Pahalakaragahamuna , Kadawatha , Sri Lanka
0112 920650
0777708487

palitha_66@yahoo.com

Contact Person for Public Queries

Dr R.P.P Karunapema
Senior Registrar in Community Medicine
253 , Pahalakaragahamuna , Kadawatha , Sri Lanka
0112 920650
0777708487

palitha_66@yahoo.com


Primary study sponsor/organization

National Sceince Foundation

47/5 Maitland Place , Colombo 7
094 11 2694170
094 11 2694754
info@nsf.ac.lk

Secondary study sponsor (If any)

Dr A. Pathmeswaran

Depatment of Public Health , University of Kealniya
0112953411
+94 11 2958337
pathmes@mfac.kln.ac.lk
http://www.med.kln.ac.lk/