Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/07/2009
Date assigned
28/08/2009
Last edited
28/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.zonmw.nl

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

Publication citations

Additional files

Editorial Notes