Should type two diabetes patients exercise at high or low intensity levels for the improvement of glycaemic control?
| ISRCTN | ISRCTN32206301 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32206301 |
| Protocol serial number | N/A |
| Sponsor | University Maastricht (UM) (The Netherlands) |
| Funders | Maastricht University (Netherlands), The Heart Centre of Hasselt (Hartcentrum Hasselt) (Netherlands) |
- Submission date
- 11/02/2008
- Registration date
- 21/04/2008
- Last edited
- 09/01/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Luc van Loon
Scientific
Scientific
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
| Phone | +31 (0)43 388 1397 |
|---|---|
| l.vanloon@hb.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised two armed clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effects of long-term exercise training intensity on glycaemic control in type two diabetes patients |
| Study acronym | ITIIRO trial |
| Study objectives | Low- and moderate-to-high intensity exercise training are equally effective for improving glycaemic control in obese, type two diabetes patients. |
| Ethics approval(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Body composition |
| Key secondary outcome measure(s) |
1. Skeletal muscle biopsy parameters |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 50 |
| Key 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 |
| Key exclusion criteria | 1. Exogenous insulin use 2. Cardiac/renal/pulmonary diseases |
| Date of first enrolment | 10/12/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
6229 ER
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No | |
| Results article | results | 01/11/2012 | Yes | No |
