|- candidate number||9422|
|- NTR Number||NTR2897|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2011|
|- Secondary IDs||P10.188 METC LUMC|
|- Public Title||Effects of a very low calorie diet in type 2 diabetes.|
|- Scientific Title||Effects of a VLCD in obese patients with type 2 diabetes and cardiovascular complications.|
|- hypothesis||We hypothesize that a very low calorie diet decreases myocardial TG stores and improves myocardial dysfunction in patients with DM2 and cardiovascular complications.|
|- Healt Condition(s) or Problem(s) studied||Cardiovascular disease, Diabetes Mellitus Type 2 (DM type II), Obesity, Adipositas|
|- Inclusion criteria||1. Diabetes mellitus type 2;|
2. BMI > 25 kg/m2 and maximum 150 kg;
3. Age > 18 years and < 70 years;
4. Cardiovascular complications: Percutaneous Coronary Intervention (PCI) in medical history and/or >50% occlusion on coronary CT;
5. NYHA class 1 and 2;
6. EGFR > 60 ml/min.
|- Exclusion criteria||1. Any significant chronic disease, except diabetes mellitus type 2;|
2. Renal, hepatic or another endocrine disease;
3. Signs of a septal myocardial infarction;
4. Difficulties to insert an intravenous catheter;
5. Severe claustrophobia;
6. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year;
8. Congenital heart disease;
9. MRI contra-indications.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-jan-2013|
|- Target number of participants||30|
|- Interventions||Our patients follow a very low calorie diet for 16 weeks. Just before and just after the diet patients will undergo a MRI. With this MRI we assess cardiac function, myocardial/hepatic triglycerides, subcutaneous and visceral fat and aortic stiffness.
The VLCD will consist of a total meal replacement (400-600 calories a day) of Prodimed. This will be expanded after 3 weeks and again after 6 weeks (guided by BMI). Participants will be seen every week to control bloodsugar, weight and bloodpressure. Participants are stimulated to continue the intervention.
|- Primary outcome||1. Heart function: Systolic and diastolic;|
2. Myocardial triglyceride content;
3. Heart dimensions.
|- Secondary outcome||1. Glucose tolerance;|
2. Body fat distribution;
3. Pulse wave velocity;
4. Liver triglyceride content.
|- Timepoints||Very low calorie diet for 16 weeks. Patients have a MRI scan before and after the diet to asses heart function, myocardial triglyceride content, etc. 18 months after start of the diet, patients will have an third MRI.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L.D. Schinkel, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.W.A. Smit|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||Rationale: |
Type 2 diabetes mellitus (DM2) is caused by profound disturbances in glucose and lipid metabolism, ultimately resulting in progressive atherosclerosis and microangiopathy.
In previous studies we have documented the metabolic and functional effects of dietary interventions on the heart in healthy subjects and patients with DM2 without overt cardiac complications. We hypothesize that dietary interventions also decrease myocardial TG stores and improve cardiac function in patients with DM2 and cardiovascular complications. This will open perspectives for dietary interventions which decrease myocardial TG stores and improve myocardial dysfunction in this category of patients.
|- Main changes (audit trail)|
|- RECORD||10-mei-2011 - 4-jun-2011|