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Effect of 12 weeks training on muscular lipid handling in relation to type 2 diabetes mellitus

Effect of 12 weeks training on muscular lipid handling in relation to type 2 diabetes mellitus: a single centre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN43780395
Enrollment
38
Registered
2009-08-28
Start date
2006-06-12
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

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])

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026