Myocardial metabolic flexibility and myocardial function in patients with complicated type 2 diabetes
| ISRCTN | ISRCTN72259923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72259923 |
| Protocol serial number | P05.195 |
| Sponsor | Leiden University Medical Center (Netherlands) |
| Funders | Center for Translational Molecular Medicine (Netherlands) [project PREDICCt (grant 01C-104)], The Netherlands Heart Foundation (Netherlands), Dutch Diabetes Research Foundation (Netherlands), Dutch Kidney Foundation (Netherlands) |
- Submission date
- 09/03/2011
- Registration date
- 30/03/2011
- Last edited
- 06/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J.W.A. Smit
Scientific
Scientific
Leids Universitair Medisch Centrum
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective intervention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Myocardial metabolic flexibility and myocardial function in patients with complicated type 2 diabetes: a prospective intervention study |
| Study objectives | To assess the effect of a short term very low calorie diet on myocardial triglyceride content and myocardial function in patients with complicated type 2 diabetes mellitus |
| Ethics approval(s) | Medical Ethics Committee of the Leiden University Medical Centre, approved on 4th August 2008, reference: P05.195/SH |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Two magnetic resonance imaging (MRI)-scans will be performed in all patients. One baseline MRI-scan will be performed while patients have used their regular diet. A second MRI-scan after a 3-day very low calorie diet (450 kcal/day) (VLCD). During the VLCD the glucose lowering medication is adjusted to prevent hypoglycemia. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Myocardial triglcyeride content measured using proton MR spectroscopy |
| Key secondary outcome measure(s) |
1. Plasma free fatty acids-blood tests |
| 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 | 17 |
| Key inclusion criteria | Patients with complicated type 2 diabetes mellitus, both men and women, age >18 years |
| Key exclusion criteria | 1. Myocardial infarction 2. Congenital cardiac disease 3. Kidney failure 4. Pregnancy or lactation 5. Contra-indications for magnetic resonance imaging (MRI) |
| Date of first enrolment | 10/02/2009 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leids Universitair Medisch Centrum
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? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
