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
Secondary identifying numbers	MEC06-3-038.5/pl

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

Universiteitssingel 50
Maastricht
6200MD
Netherlands

Phone	+31 (0)43 388 1317
Email	matthijs.hesselink@bw.unimaas.nl

Study information

Study design	Single centre interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	12/06/2006
Completion date	18/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	18 diabetic subjects, 20 healthy control subjects
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

Sponsor information

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

Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands

Phone	+31 (0)70 349 51 11
Email	info@zonmw.nl
Website	http://www.zonmw.nl
"ROR"	https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

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

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/05/2011	23/10/2020	Yes	No

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.