We hypothesize that a very low calorie diet decreases myocardial TG stores and improves myocardial dysfunction in patients with DM2 and cardiovascular complications.
ID
Bron
Verkorte titel
Aandoening
Diabetes mellitus type 2
Cardiovascular complications
Adiposity/obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Heart function: Systolic and diastolic;<br>
2. Myocardial triglyceride content;<br>
3. Heart dimensions.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We hypothesize that a very low calorie diet decreases myocardial TG stores and improves myocardial dysfunction in patients with DM2 and cardiovascular complications.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
7. Pregnancy;
8. Congenital heart disease;
9. MRI contra-indications.
Opzet
Deelname
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