Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/01/2010
Date assigned
16/03/2010
Last edited
16/03/2010
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 Stephan Praet

ORCID ID

Contact details

Erasmus University Medical Centre
Office H-021
's Gravendijkwal 230
Rotterdam
3000 CE
Netherlands
s.praet@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P04.1659L (Dutch CCMO registration number)

Study information

Scientific title

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

Acronym

Study hypothesis

Exercise (partly) reverses mitochondrial dysfunction in patients with long-term type 2 diabetes and co-morbidity.

Ethics approval

1. Medical Ethics Committee of the Maxima Medical Centre approved of the primary exercise intervention study on the 27th December 2004 (CCMO-registrationnumber P04.1659L). Subsequent amendment requests for extension of the study (including P06.0005L) were also approved.
2. Central Committee on Research inv. Human Subjects (CCMO) approved of the primary intervention study on the 21st December 2004 (CCMO-registration number: P04.1659)

Study design

Single centre longitudinal intervention case-control study with mixed design

Primary study design

Interventional

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (Dutch only)

Condition

Type 2 diabetes

Intervention

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 endurance exercise.

Groups B and C served as control groups to enable a baseline comparison.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in phosphocreatine recovery time constant (τPCr) 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 outcome measures

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)

Overall trial start date

01/01/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Group A: 12; group B: 12; group C: 12

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus University Medical Centre
Rotterdam
3000 CE
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (Netherlands)

Sponsor details

Department of Human Movement Sciences
Universiteitssingel 50
Maastricht
6229 ER
Netherlands

Sponsor type

University/education

Website

http://www.unimaas.nl

Funders

Funder type

Government

Funder name

Ministry of Health, Welfare and Sport (VWS) (Netherlands) - unrestricted research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Eindhoven University of Technology (Netherlands) - Department of Biomedical NMR

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Diabetes Research Foundation (Netherlands) (ref: 2004.00.040)

Alternative name(s)

Dutch Diabetes Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

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