Contact information
Type
Scientific
Primary contact
Dr Luc van Loon
ORCID ID
Contact details
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
+31 (0)43 388 1397
l.vanloon@hb.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of long-term exercise training intensity on glycaemic control in type two diabetes patients
Acronym
ITIIRO trial
Study hypothesis
Low- and moderate-to-high intensity exercise training are equally effective for improving glycaemic control in obese, type two diabetes patients.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type two diabetes mellitus
Intervention
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
Brussels
B-3500
Belgium
Website: http://www.vub.ac.be
2. Virga Jesse Hospital (Belgium)
Stadomvaart 11
Hasselt
B-3500
Belgium
Email: rego@virgajesse.be
Website: http://www.virgajesse.be
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
1. Skeletal muscle biopsy parameters
2. Physical activity level
3. Food intake
All measurements were made at 0 and 8 weeks of exercise training.
Overall trial start date
10/12/2003
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
50
Participant exclusion criteria
1. Exogenous insulin use
2. Cardiac/renal/pulmonary diseases
Recruitment start date
10/12/2003
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Belgium
Trial participating centre
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
Sponsor information
Organisation
University Maastricht (UM) (The Netherlands)
Sponsor details
Postbus 616
Maastricht
6200 MD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Maastricht University (Netherlands)
Alternative name(s)
Maastricht University, UM
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Funder name
The Heart Centre of Hasselt (Hartcentrum Hasselt) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19370339
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22949030
Publication citations
-
Results
Hansen D, Dendale P, Jonkers RA, Beelen M, Manders RJ, Corluy L, Mullens A, Berger J, Meeusen R, van Loon LJ, Continuous low- to moderate-intensity exercise training is as effective as moderate- to high-intensity exercise training at lowering blood HbA(1c) in obese type 2 diabetes patients., Diabetologia, 2009, 52, 9, 1789-1797, doi: 10.1007/s00125-009-1354-3.
-
Results
Shaw CS, Shepherd SO, Wagenmakers AJ, Hansen D, Dendale P, van Loon LJ, Prolonged exercise training increases intramuscular lipid content and perilipin 2 expression in type I muscle fibers of patients with type 2 diabetes., Am. J. Physiol. Endocrinol. Metab., 2012, 303, 9, E1158-65, doi: 10.1152/ajpendo.00272.2012.