Welcome
Support Centre
22 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Intervention phase of the Tehran Lipid and Glucose Study (TLGS phase II)
ISRCTN ISRCTN52588395
DOI 10.1186/ISRCTN52588395
ClinicalTrials.gov identifier
EudraCT number
Public title Intervention phase of the Tehran Lipid and Glucose Study (TLGS phase II)
Scientific title Prevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study Phase II
Acronym TLGS II
Serial number at source N/A
Study hypothesis The Tehran Lipid and Glucose Study (TLGS) is a long term integrated community-based programme for prevention of non-communicable disorders (NCD) by development of a healthy lifestyle and reduction of NCD risk factors. The primary research goal is an evaluation of the feasibility and effectiveness of lifestyle modification interventions in preventing or postponing the development of NCD risk factors and outcomes in a population in nutrition transition. Secondary research goals include determining differences in the prevalence of major NCD risk factors and outcomes between intervention and control groups with special focus on angina pectoris, myocardial infarction, cerebrovascular events, diabetes mellitus, hypertension and dyslipidaemia.
Lay summary
Ethics approval The National Research Council of the Islamic Republic of Iran (ref: 121); performed with the approval of the Human Research Review Committee of the Endocrine Research Centre, Shahid Beheshti University (MC).
Study design Randomised community intervention (controlled field trial)
Countries of recruitment Iran
Disease/condition/study domain Non-communicable diseases (NCD)
Participants - inclusion criteria 1. Individuals aged 3 years and over, either sex
2. Residents of the District 13 of Tehran
3. Under the coverage of three medical health centres, selected using multistage cluster random sampling method
4. Agree for all members of each family, including those not having risk factors, to be enrolled
Participants - exclusion criteria Mentally disabled persons
Anticipated start date 01/03/1999
Anticipated end date 01/03/2020
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 15,005 (5,630 cases for intervention group)
Interventions Primary, secondary and tertiary interventions were designed based on specific target groups including school children, housewives, and high-risk persons. Officials of various sectors such as health, education, municipality, police, media, traders and community leaders were actively engaged as decision makers and collaborators. Interventional strategies were based on lifestyle modifications in diet, smoking and physical activity through face-to-face education, leaflets and brochures, school programme alterations, training volunteers as health team and treating patients with NCD risk factors. Collection of demographic, clinical and laboratory data will be repeated every 3 years to assess the effects of different interventions in the intervention group as compared to control group.
Primary outcome measure(s) Major NCD risk factors including the following:
1. Glucose disorders (oral glucose tolerance test, fasting blood sugar)
2. Dyslipidaemia: serum total cholesterol, triglycerides, low density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C)
3. Obesity: a body mass index (BMI) of 25 to 29.9 kg/m^2 in adults is considered as overweight and a BMI equal to or more than 30 kg/m^2 is defined as obesity. Obesity and overweight in children and adolescents are defined according to international cut-off points for body mass index. Truncal obesity is defined as a waist-hip ratio (WHR) more than 0.95 in adult men and more than 0.8 in adult women.
4. Smoking, assessed by a 110-item questionnaire and Modifiable Activity Questionnaire (MAQ)
5. Hypertension (HTN)
6. Level of physical activity, assessed by a 110-item questionnaire and Modifiable Activity Questionnaire (MAQ)
7. Nutritional status, assessed by interviews

The primary outcomes are assessed every 3 years.
Secondary outcome measure(s) 1. Any significant medical events
2. Mortality

The secondary outcomes are assessed annually.
Sources of funding 1. National Research Council, Ministry of Health (Iran)
2. Research Institute for Endocrine Sciences (Iran)
Trial website http://endocrine.ac.ir/English/study.aspx
Publications 1. 2000 rationale and design in
Azizi F, Rahmani M, Emami, H, Majid M. Tehran lipid and glucose study (TLGS): rationale and design. CVD Prevention 2000; 3:50-3.
2. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12643001
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17999777
4. 2008 nutritional intervention results in http://www.ncbi.nlm.nih.gov/pubmed/18349527
5. 2008 anthropometric parameter results in http://www.ncbi.nlm.nih.gov/pubmed/18772585
6. 2008 nested case control study results in http://www.ncbi.nlm.nih.gov/pubmed/18533046
7. 2008 assessment of alternative definitions results in http://www.ncbi.nlm.nih.gov/pubmed/18282630
8. 2008 prospective study results in http://www.ncbi.nlm.nih.gov/pubmed/18068961
9. 2009 phase II protocol in http://www.ncbi.nlm.nih.gov/pubmed/19166627
10. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20494239
Contact name Prof  Fereidoun  Azizi
  Address Research Institute for Endocrine Sciences
No 24 Parvaneh Avenue
Yaman Street
Velenjak
  City/town Tehran
  Zip/Postcode 19395-4763
  Country Iran
  Tel +98 (0)21 2240 9309
  Fax +98 (0)21 2240 2463
  Email azizi@endocrine.ac.ir
Sponsor Research Institute for Endocrine Sciences (Iran)
  Address No 24 Parvaneh Avenue
Yaman Street
Velenjak
  City/town Tehran
  Zip/Postcode 19395-4763
  Country Iran
  Tel +98 (0)21 2243 2500 or 2240 9309
  Fax +98 (0)21 2241 6264 or 2240 2463
  Email azizi@endocrine.ac.ir
  Sponsor website: http://endocrine.ac.ir
Date applied 11/10/2008
Last edited 25/05/2010
Date ISRCTN assigned 27/11/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.