Contact information
Type
Scientific
Primary contact
Dr Matthijs Hesselink
ORCID ID
Contact details
Universiteitssingel 50
Maastricht
6200MD
Netherlands
+31 (0)43 388 1317
matthijs.hesselink@bw.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC06-3-038.5/pl
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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
12/06/2006
Overall trial end date
18/07/2008
Reason abandoned
Eligibility
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
Patient
Age group
Adult
Gender
Male
Target number of participants
18 diabetic subjects, 20 healthy control subjects
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
12/06/2006
Recruitment end date
18/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Universiteitssingel 50
Maastricht
6200MD
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands
+31 (0)70 349 51 11
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
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
Location
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
Results - basic reporting
Publication summary