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Should type two diabetes patients exercise at high or low intensity levels for the improvement of glycaemic control?
DOI 10.1186/ISRCTN32206301
ClinicalTrials.gov identifier
EudraCT number
Public title Should type two diabetes patients exercise at high or low intensity levels for the improvement of glycaemic control?
Scientific title Effects of long-term exercise training intensity on glycaemic control in type two diabetes patients
Acronym ITIIRO trial
Serial number at source N/A
Study hypothesis Low- and moderate-to-high intensity exercise training are equally effective for improving glycaemic control in obese, type two diabetes patients.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the Research Ethics Committee of the Virga Jesse Hospital, Hasselt (Belgium) on the 25th November 2004 (ref: 04.38/cardio04.05).
Study design Randomised two armed clinical trial
Countries of recruitment Belgium
Disease/condition/study domain Type two diabetes mellitus
Participants - inclusion criteria 1. Obese, male, type two diabetes patients (at least one year diagnosed with disease)
2. Have not participated in physical activity programs or caloric intake restriction programs for at least two years ahead of study
3. Aged 40 - 75 years
Participants - exclusion criteria 1. Exogenous insulin use
2. Cardiac/renal/pulmonary diseases
Anticipated start date 10/12/2003
Anticipated end date 31/12/2007
Status of trial Completed
Patient information material
Target number of participants 50
Interventions All patients were subjected to eight weeks of endurance exercise training, three days each week, one subgroup at high intensity while the other at low intensity. Pharmacological treatment and caloric intake were not changed. All patients were followed for eight weeks.

Other sponsors:
1. Vrije Universiteit Brussel (Belgium)
Pleinlaan 2
Website: http://www.vub.ac.be

2. Virga Jesse Hospital (Belgium)
Stadomvaart 11
Email: rego@virgajesse.be
Website: http://www.virgajesse.be
Primary outcome measure(s) 1. Body composition
2. Blood plasma parameters
3. Exercise performance capacity

All measurements were made at 0 and 8 weeks of exercise training.
Secondary outcome measure(s) 1. Skeletal muscle biopsy parameters
2. Physical activity level
3. Food intake

All measurements were made at 0 and 8 weeks of exercise training.
Sources of funding 1. Maastricht University (Netherlands)
2. The Heart Centre of Hasselt (Hartcentrum Hasselt) (Netherlands)
Trial website
Publications 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19370339
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22949030
Contact name Dr  Luc  van Loon
  Address Universiteitssingel 50
  City/town Maastricht
  Zip/Postcode 6229 ER
  Country Netherlands
  Tel +31 (0)43 388 1397
  Fax +31 (0)43 367 0972
  Email l.vanloon@hb.unimaas.nl
Sponsor University Maastricht (UM) (The Netherlands)
  Address Postbus 616
  City/town Maastricht
  Zip/Postcode 6200 MD
  Country Netherlands
  Sponsor website: http://www.unimaas.nl
Date applied 11/02/2008
Last edited 09/01/2013
Date ISRCTN assigned 21/04/2008
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