Home » Trials » SLCTR/2008/001
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.
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SLCTR Registration Number
SLCTR/2008/001
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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 or Health Condition(s) Studied
Diabetes primary prevention
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial 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)
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/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Available
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)
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1.
·Fasting plasma glucose ·Fasting serum insulin(FSI) ·Conversion to normoglycemic state ·Conversion to diabetes |
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Secondary outcome(s)
|
1.
•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 |
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Target number/sample size
185
Countries of recruitment
Sri Lanka
Anticipated start date
2006-10-01
Anticipated end date
2009-10-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Sceince Foundation,Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2006-04-06
Approval number
P5/03/2006
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
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/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
