Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/03/2011
Date assigned
08/04/2011
Last edited
08/04/2011
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 Eelco De Koning

ORCID ID

Contact details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P10.018

Study information

Scientific title

Effect of exercise training on ectopic fat accumulation in patients with type 2 diabetes

Acronym

Study hypothesis

Determining the effect of an exercise program on ectopic fat accumulation in heart, liver and skeletal muscle

Ethics approval

Medical Ethics Committee of Leiden University Medical Center approved on 19/02/2011 ref: protocol number: P10.018

Study design

Open prospective intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

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

Condition

Type 2 diabetes mellitus

Intervention

Patients are studied before and after a six month exercise intervention

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Visceral and subcutaneous abdominal fat volume
2. Myocardial, myocellular and hepatic triglyceride content
3. Epi- and pericardal fat volume

Secondary outcome measures

1. Cardiac function
2. Anthropometric measures (weight, blood pressure)
3. Energy intake and expenditure
4. Metabolic parameters (HbA1c, lipid levels from blood plasma)

Overall trial start date

24/02/2010

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ages of 18 - 70 years
2. Diagnosis of type 2 diabetes mellitus

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

14

Participant exclusion criteria

1. Complications of diabetes (retinopathy, neuropathy, nephropathy)
2. Hypertension (systolic blood pressure > 165 mmHg and/or diastolic blood pressure > 95 mmHg)
3. Body mass index (BMI) > 35kg/m2
4. Smoking
5. Cardiac diseases
6. Claustrophobia or any other contra-indication for magnetic resonance imaging (MRI)

Recruitment start date

24/02/2010

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (Netherlands)

Sponsor details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Center for Translational Molecular Medicine (Netherlands) (grant 01C-104)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Heart Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Diabetes Research Foundation (Netherlands)

Alternative name(s)

Dutch Diabetes Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Dutch Kidney Foundation (Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Bas van de Goor Foundation (Netherlands)

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