Effect of 12 weeks training on muscular lipid handling in relation to type 2 diabetes mellitus
| ISRCTN | ISRCTN43780395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43780395 |
| Protocol serial number | MEC06-3-038.5/pl |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
| Funder | The Netherlands Organisation for Scientific Research (NWO) (Netherlands) - VIDI Research Grant for Innovative Research (ref: 917.66.359) |
- Submission date
- 06/07/2009
- Registration date
- 28/08/2009
- Last edited
- 23/10/2020
- 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 Matthijs Hesselink
Scientific
Scientific
Universiteitssingel 50
Maastricht
6200MD
Netherlands
| Phone | +31 (0)43 388 1317 |
|---|---|
| matthijs.hesselink@bw.unimaas.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of 12 weeks training on muscular lipid handling in relation to type 2 diabetes mellitus: a single centre randomised controlled trial |
| Study objectives | Training improves insulin sensitivity via an increase in fat oxidative capacity of muscle, thereby reducing the accumulation of fatty acid metabolites like diacylglycerol (DAG). |
| Ethics approval(s) | Local Medical Ethics Committee (Medisch Ethische Commissie academisch ziekenhuis Maastricht/Universiteit Maastricht [MEC azM/UM]) approved on the 12th June 2009 (ref: MEC06-3-038.5/pl) |
| Health condition(s) or problem(s) studied | Diabetes |
| Intervention | All subjects were engaged in an exercise program for 12 weeks consisting of a combination of aerobic and resistance exercise. The aerobic exercise was carried out twice a week for 30 minutes at 70% of their maximum aerobic capacity. Resistance exercise was performed once a week and consisted of three series of 10 repetitions at 60% of their pre-training maximum voluntary contraction (MVC). The mode of aerobic and resistance activity involved cycling exercise and a "circuit" of eight exercises concentrating on large muscle groups respectively. Each 4 weeks, maximal aerobic capacity and MVC was re-assessed, and the exercise intensity was adjusted. Skilled trainers supervised the exercise sessions to ensure compliance and to reduce the risk of injuries. |
| Intervention type | Other |
| Primary outcome measure(s) |
insulin sensitivity (hyperinsulinaemic-euglycaemic clamp). All measurements are done at baseline and repeated after the 12-week training period. |
| Key secondary outcome measure(s) |
All measurements are done at baseline and repeated after the 12-week training period: |
| Completion date | 18/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 38 |
| Total final enrolment | 11 |
| Key inclusion criteria | All subjects: 1. Male sex 2. Aged 50 - 65 years 3. Body mass index (BMI) 27 - 35 kg/m^2 4. Stable dietary habits and physical activity levels For diabetic patients only: 5. Must be on sulphonylurea or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months 6. Well-controlled diabetes: fasting plasma glucose concentration must be less than 10.0 mmol/l at the time of screening For healthy controls only: 7. Normoglycaemic according to World Health Organization (WHO) criteria (oral glucose tolerance test [OGTT]) |
| Key exclusion criteria | All subjects: 1. Female sex 2. Unstable body weight (weight gain or loss greater than 3 kg in the past three months) 3. Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study 4. Active cardiovascular disease. This will be determined by performing an exercise electrocardiogram (ECG), by questionnaires and by screening on medication. Furthermore, all subjects will undergo a physical examination by a medical doctor. 5. Liver disease or liver dysfunction (alanine aminotransferase [ALAT] greater than 2.5 x increased) 6. Renal dysfunction (creatinine greater than 2 x increased) 7. Systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg 8. Haemoglobin less than 7.5 mmol/l (anaemia) 9. Use of medications know to interfere with glucose homeostasis (i.e. corticosteroids) 10. Use of anti-thrombotic medication 11. Claustrophobia and metal implants (with respect to magnetic resonance imaging [MRI]) 12. Abuse of drugs and/or alcohol 13. Participation in another biomedical study within 1 month before the first screening visit For diabetic subjects: 14. Severe diabetes which requires application of insulin or patients with diabetes-related complications |
| Date of first enrolment | 12/06/2006 |
| Date of final enrolment | 18/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Universiteitssingel 50
Maastricht
6200MD
Netherlands
6200MD
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 | 26/05/2011 | 23/10/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
