The effect of a structured exercise program on oxidative capacity and mitochondrial (dys)function in type 2 diabetes
| ISRCTN | ISRCTN23677189 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23677189 |
| Secondary identifying numbers | P04.1659L (Dutch CCMO registration number) |
- Submission date
- 08/01/2010
- Registration date
- 16/03/2010
- Last edited
- 16/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephan Praet
Scientific
Scientific
Erasmus University Medical Centre
Office H-021
's Gravendijkwal 230
Rotterdam
3000 CE
Netherlands
| s.praet@erasmusmc.nl |
Study information
| Study design | Single centre longitudinal intervention case-control study with mixed design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Dutch only) |
| Scientific title | A study on the training response of combined strength and endurance training in insulin dependent type 2 diabetic subjects with co-morbidity |
| Study objectives | Exercise (partly) reverses mitochondrial dysfunction in patients with long-term type 2 diabetes and co-morbidity. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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) |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Group A: 12; group B: 12; group C: 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus University Medical Centre
Rotterdam
3000 CE
Netherlands
3000 CE
Netherlands
Sponsor information
University Maastricht (UM) (Netherlands)
University/education
University/education
Department of Human Movement Sciences
Universiteitssingel 50
Maastricht
6229 ER
Netherlands
| Website | http://www.unimaas.nl |
|---|---|
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Government
Ministry of Health, Welfare and Sport (VWS) (Netherlands) - unrestricted research grant
No information available
Eindhoven University of Technology (Netherlands) - Department of Biomedical NMR
No information available
Dutch Diabetes Research Foundation (Netherlands) (ref: 2004.00.040)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Diabetes Research Foundation
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
