Effect of exercise training on fat distribution in patients with type 2 diabetes
| ISRCTN | ISRCTN26977705 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26977705 |
| Secondary identifying numbers | P10.018 |
- Submission date
- 25/03/2011
- Registration date
- 08/04/2011
- Last edited
- 08/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Eelco De Koning
Scientific
Scientific
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| Study design | Open prospective intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of exercise training on ectopic fat accumulation in patients with type 2 diabetes |
| Study objectives | Determining the effect of an exercise program on ectopic fat accumulation in heart, liver and skeletal muscle |
| Ethics approval(s) | Medical Ethics Committee of Leiden University Medical Center approved on 19/02/2011 ref: protocol number: P10.018 |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Patients are studied before and after a six month exercise intervention |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 24/02/2010 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 14 |
| Key inclusion criteria | 1. Ages of 18 - 70 years 2. Diagnosis of type 2 diabetes mellitus |
| Key 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) |
| Date of first enrolment | 24/02/2010 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Leiden University Medical Center (Netherlands)
University/education
University/education
Albinusdreef 2
Leiden
2333 ZA
Netherlands
"ROR" |
https://ror.org/05xvt9f17 |
|---|
Funders
Funder type
Research organisation
Center for Translational Molecular Medicine (Netherlands) (grant 01C-104)
No information available
Netherlands Heart Foundation (Netherlands)
No information available
Dutch Diabetes Research Foundation (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Diabetes Research Foundation
- Location
- Netherlands
Dutch Kidney Foundation (Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Kidney Foundation
- Location
- Netherlands
Bas van de Goor Foundation (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
