Effect of exercise training on fat distribution in patients with type 2 diabetes
| ISRCTN | ISRCTN26977705 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26977705 |
| Protocol serial number | P10.018 |
| Sponsor | Leiden University Medical Center (Netherlands) |
| Funders | Center for Translational Molecular Medicine (Netherlands) (grant 01C-104), Netherlands Heart Foundation (Netherlands), Dutch Diabetes Research Foundation (Netherlands), Dutch Kidney Foundation (Netherlands), Bas van de Goor Foundation (Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Open prospective intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Visceral and subcutaneous abdominal fat volume |
| Key secondary outcome measure(s) |
1. Cardiac function |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
