|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| The effect of a structured exercise program on oxidative capacity and mitochondrial (dys)function in type 2 diabetes |
| ISRCTN | ISRCTN23677189 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of a structured exercise program on oxidative capacity and mitochondrial (dys)function in type 2 diabetes |
| Scientific title | A study on the training response of combined strength and endurance training in insulin dependent type 2 diabetic subjects with co-morbidity |
| Acronym | N/A |
| Serial number at source | P04.1659L (Dutch CCMO registration number) |
| Study hypothesis | Exercise (partly) reverses mitochondrial dysfunction in patients with long-term type 2 diabetes and co-morbidity. |
| Lay summary | |
| Ethics approval |
1. Medical Ethics Committee of the Maxima Medical Centre approved of the primary exercise intervention study on the 27th December 2004 (CCMO-registrationnumber P04.1659L). Subsequent amendment requests for extension of the study (including P06.0005L) were also approved.
2. Central Committee on Research inv. Human Subjects (CCMO) approved of the primary intervention study on the 21st December 2004 (CCMO-registration number: P04.1659) |
| Study design | Single centre longitudinal intervention case-control study with mixed design |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Type 2 diabetes |
| Participants - inclusion criteria |
Group A: long-term type 2 diabetes group (intervention group):
1. Male 2. Diagnosed with type 2 diabetes greater than 5 years according to World Health Organization (WHO) criteria 3. Exogenous insulin use greater than 2 years 4. Clinical signs of diabetic polyneuropathy and/or other diabetes-related 5. Aged 45 - 70 years 6. Body mass index (BMI) 26 - 42 kg/m^2 7. Sedentary behaviour 8. Agreement to volunteer for the study by giving a written informed consent Group B: intermediate hyperglycaemia group/early-diagnosed type 2 diabetes patients: 1. Male 2. Intermediate hyperglycemia according to WHO criteria 3. HbA1c less than or equal to 6.0% 4. Aged 45 - 70 years (matched with group A) 5. BMI 26 - 42 kg/m^2 (matched with group A) 6. Wmax (cycle ergometer): 100 - 220 Watt 7. Sedentary behaviour 8. Agreement to volunteer for the study by giving a written informed consent Group C: overweight/obese but otherwise healthy subjects with normal glucose tolerance: 1. Male 2. Normal glucose tolerance according to WHO criteria 3. HbA1c less than or equal to 6.0% 4. Aged 45 - 70 years 5. BMI 26 - 42 kg/m^2 (matched with group A) 6. Wmax: 100 - 220 Watt 7. Sedentary behaviour 8. Agreement to volunteer for the study by giving a written informed consent |
| Participants - exclusion criteria |
Group A:
1. Unable to participate in a structured exercise intervention for 12 months 2. Use of thiazolidinions 3. Use of beta-blocker therapy less than 6 months Group B and C: 1. Family history of type 2 diabetes 2. Use of beta-blocker therapy 3. History/clinical signs of cardiovascular and/or peripheral arterial disease |
| Anticipated start date | 01/01/2005 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet (Dutch only) |
| Target number of participants | Group A: 12; group B: 12; group C: 12 |
| Interventions |
Group A: usual care combined with a structured exercise intervention (3 times/week) for 12 months consisting of progressive resistance type of exercise combined with high-intensity interval type of endurance exercise.
Groups B and C served as control groups to enable a baseline comparison. |
| Primary outcome measure(s) | Change in phosphocreatine recovery time constant (τPCr) as a measure of in-vivo muscle oxidative capacity as measured using 31 P NMR spectroscopy, measured at t = 22 weeks and t = 52 weeks following the beginning of the exercise intervention. |
| Secondary outcome measure(s) |
1. Ex vivo mitochondrial density, quality and functioning in skeletal muscle (as measured through determining mitochondrial density (citrate synthase, mtDNA copy number) and ex vivo function and expression of Krebs cycle and OXPHOS related genes (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention)
2. Change in maximal oxygen uptake capacity as measured on a bicycle ergometer (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 3. Change in submaximal oyxgen uptake and heart rate (at 50% Wmax) on a bicycle ergometer (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 4. Change in HbA1c and exogenous insulin use (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 5. Change in markers for chronic inflammation (high sensitivity C-reactive protein [hsCRP], tumour necrotising factor [TNF]-alpha) and adipokines (adoponectin) (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 6. Change in body composition (as measured with dual energy X-ray absorptiometry [DEXA]/magnetic resonance imaging [MRI], waist circumference) (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 7. Change in muscle strength of upper and lower extremities (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 8. Change in quality of life (36-item short form [SF-36]) (measured at t = 22 and 52 weeks following the beginning of the exercise intervention) 9. Change in activity level (Tecumseh questionnaire) (measured at t = 22 and 52 weeks following the beginning of the exercise intervention) |
| Sources of funding |
1. Ministry of Health, Welfare and Sport (VWS) (Netherlands) - unrestricted research grant
2. Eindhoven University of Technology (Netherlands) - Department of Biomedical NMR 3. Dutch Diabetes Research Foundation (Netherlands) (ref: 2004.00.040) |
| Trial website | |
| Publications | |
| Contact name | Dr Stephan Praet |
| Address |
Erasmus University Medical Centre
Office H-021 's Gravendijkwal 230 |
| City/town | Rotterdam |
| Zip/Postcode | 3000 CE |
| Country | Netherlands |
| s.praet@erasmusmc.nl | |
| Sponsor | University Maastricht (UM) (Netherlands) |
| Address |
Department of Human Movement Sciences
Universiteitssingel 50 |
| City/town | Maastricht |
| Zip/Postcode | 6229 ER |
| Country | Netherlands |
| Sponsor website: | http://www.unimaas.nl |
| Date applied | 08/01/2010 |
| Last edited | 16/03/2010 |
| Date ISRCTN assigned | 16/03/2010 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|