Myocardial metabolic flexibility and myocardial function in patients with complicated type 2 diabetes
| ISRCTN | ISRCTN72259923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72259923 |
| Secondary identifying numbers | P05.195 |
- 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
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
| Study design | Prospective intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Myocardial metabolic flexibility and myocardial function in patients with complicated type 2 diabetes: a prospective intervention study |
| Study hypothesis | 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 |
| Condition | 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 | 1. Myocardial triglcyeride content measured using proton MR spectroscopy 2. Cardiac function-measured by MRI Measured at baseline and at day 4 |
| Secondary outcome measures | 1. Plasma free fatty acids-blood tests 2. Plasma glucose-blood tests 3. Waist fat Measured at baseline and at day 4 |
| Overall study start date | 10/02/2009 |
| Overall study end date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 17 |
| Participant inclusion criteria | Patients with complicated type 2 diabetes mellitus, both men and women, age >18 years |
| Participant exclusion criteria | 1. Myocardial infarction 2. Congenital cardiac disease 3. Kidney failure 4. Pregnancy or lactation 5. Contra-indications for magnetic resonance imaging (MRI) |
| Recruitment start date | 10/02/2009 |
| Recruitment end date | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leids Universitair Medisch Centrum
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Leiden University Medical Center (Netherlands)
University/education
University/education
Leiden University Medical Center
c/o Prof. J.W.A. Smit
Albinusdreef 2
Leiden
2333 ZA
Netherlands
"ROR" |
https://ror.org/05xvt9f17 |
|---|
Funders
Funder type
Government
Center for Translational Molecular Medicine (Netherlands) [project PREDICCt (grant 01C-104)]
No information available
The 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
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2014 | Yes | No |
