Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Matthijs Hesselink


Contact details

Universiteitssingel 50
+31 (0)43 388 1317

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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 hypothesis

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

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)

Study design

Single centre interventional randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




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



Not Applicable

Drug names

Primary outcome measure

insulin sensitivity (hyperinsulinaemic-euglycaemic clamp). All measurements are done at baseline and repeated after the 12-week training period.

Secondary outcome measures

All measurements are done at baseline and repeated after the 12-week training period:
1. Proteins involved in lipid handling
2. Lipid metabolites in skeletal muscle
3. Skeletal muscle oxidative capacity (muscle biopsies, aerobic exercise test)
4. Lipid accumulation in heart muscle and skeletal muscle (MRS)
5. Body composition
6. Mitochondrial markers and peripheral lipid accumulation in muscle (muscle biopsies)
7. Expression of proteins involved in fatty acid handling
8. Insulin signalling in skeletal muscle (muscle biopsies)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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])

Participant type


Age group




Target number of participants

18 diabetic subjects, 20 healthy control subjects

Total final enrolment


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Universiteitssingel 50

Sponsor information


The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
+31 (0)70 349 51 11

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

The Netherlands Organisation for Scientific Research (NWO) (Netherlands) - VIDI Research Grant for Innovative Research (ref: 917.66.359)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2011 results in (added 23/10/2020)

Publication citations

Additional files

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.