The effect of a structured exercise program on oxidative capacity and mitochondrial (dys)function in type 2 diabetes

A study on the training response of combined strength and endurance training in insulin dependent type 2 diabetic subjects with co-morbidity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23677189

Enrollment

Registered

2010-03-16

Start date

2005-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Group A: usual care combined with a structured exercise intervention (3 times/week) for 12 months consisting of progressive resistance type of exercise combined with high-intensity interval type of en

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Group A: long-term type 2 diabetes group (intervention group): 1. Male 2. Diagnosed with type 2 diabetes greater than 5 years according to World Health Organization (WHO) criteria 3. Exogenous insulin use greater than 2 years 4. Clinical signs of diabetic polyneuropathy and/or other diabetes-related 5. Aged 45 - 70 years 6. Body mass index (BMI) 26 - 42 kg/m^2 7. Sedentary behaviour 8. Agreement to volunteer for the study by giving a written informed consent Group B: intermediate hyperglycaemia group/early-diagnosed type 2 diabetes patients: 1. Male 2. Intermediate hyperglycemia according to WHO criteria 3. HbA1c less than or equal to 6.0% 4. Aged 45 - 70 years (matched with group A) 5. BMI 26 - 42 kg/m^2 (matched with group A) 6. Wmax (cycle ergometer): 100 - 220 Watt 7. Sedentary behaviour 8. Agreement to volunteer for the study by giving a written informed consent Group C: overweight/obese but otherwise healthy subjects with normal glucose tolerance: 1. Male 2. Normal glucose tolerance according to WHO criteria 3. HbA1c less than or equal to 6.0% 4. Aged 45 - 70 years 5. BMI 26 - 42 kg/m^2 (matched with group A) 6. Wmax: 100 - 220 Watt 7. Sedentary behaviour 8. Agreement to volunteer for the study by giving a written informed consent

Exclusion criteria

Exclusion criteria: Group A: 1. Unable to participate in a structured exercise intervention for 12 months 2. Use of thiazolidinions 3. Use of beta-blocker therapy less than 6 months Group B and C: 1. Family history of type 2 diabetes 2. Use of beta-blocker therapy 3. History/clinical signs of cardiovascular and/or peripheral arterial disease

Design outcomes

Primary

Measure	Time frame
Change in phosphocreatine recovery time constant (tPCr) as a measure of in-vivo muscle oxidative capacity as measured using 31 P NMR spectroscopy, measured at t = 22 weeks and t = 52 weeks following the beginning of the exercise intervention.	—

Secondary

Measure	Time frame
1. Ex vivo mitochondrial density, quality and functioning in skeletal muscle (as measured through determining mitochondrial density (citrate synthase, mtDNA copy number) and ex vivo function and expression of Krebs cycle and OXPHOS related genes (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 2. Change in maximal oxygen uptake capacity as measured on a bicycle ergometer (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 3. Change in submaximal oyxgen uptake and heart rate (at 50% Wmax) on a bicycle ergometer (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 4. Change in HbA1c and exogenous insulin use (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 5. Change in markers for chronic inflammation (high sensitivity C-reactive protein [hsCRP], tumour necrotising factor [TNF]-alpha) and adipokines (adoponectin) (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 6. Change in body composition (as measured with dual energy X-ray absorptiometry [DEXA]/magnetic resonance imaging [MRI], waist circumference) (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 7. Change in muscle strength of upper and lower extremities (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 8. Change in quality of life (36-item short form [SF-36]) (measured at t = 22 and 52 weeks following the beginning of the exercise intervention) 9. Change in activity level (Tecumseh questionnaire) (measured at t = 22 and 52 weeks following the beginning of the exercise intervention)	—

Measure

Time frame

1. Ex vivo mitochondrial density, quality and functioning in skeletal muscle (as measured through determining mitochondrial density (citrate synthase, mtDNA copy number) and ex vivo function and expression of Krebs cycle and OXPHOS related genes (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 2. Change in maximal oxygen uptake capacity as measured on a bicycle ergometer (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 3. Change in submaximal oyxgen uptake and heart rate (at 50% Wmax) on a bicycle ergometer (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 4. Change in HbA1c and exogenous insulin use (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 5. Change in markers for chronic inflammation (high sensitivity C-reactive protein [hsCRP], tumour necrotising factor [TNF]-alpha) and adipokines (adoponectin) (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 6. Change in body composition (as measured with dual energy X-ray absorptiometry [DEXA]/magnetic resonance imaging [MRI], waist circumference) (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 7. Change in muscle strength of upper and lower extremities (measured at t = 11, 22 and 52 weeks following the beginning of the exercise intervention) 8. Change in quality of life (36-item short form [SF-36]) (measured at t = 22 and 52 weeks following the beginning of the exercise intervention) 9. Change in activity level (Tecumseh questionnaire) (measured at t = 22 and 52 weeks following the beginning of the exercise intervention)

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026