Effects of a very low calorie diet in type 2 diabetes.

Effects of a VLCD in obese patients with type 2 diabetes and cardiovascular complications.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24965

Enrollment

Registered

2011-05-10

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 Cardiovascular complications Adiposity/obesity

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, s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diabetes mellitus type 2; 2. BMI > 25 kg/m2 and maximum 150 kg; 3. Age > 18 years and 50% occlusion on coronary CT; 5. NYHA class 1 and 2; 6. EGFR > 60 ml/min.

Exclusion criteria

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; 7. Pregnancy; 8. Congenital heart disease; 9. MRI contra-indications.

Design outcomes

Primary

Measure	Time frame
1. Heart function: Systolic and diastolic; 2. Myocardial triglyceride content; 3. Heart dimensions.	—

Secondary

Measure	Time frame
1. Glucose tolerance; 2. Body fat distribution; 3. Pulse wave velocity; 4. Liver triglyceride content.	—

Contacts

Public ContactL.D. Schinkel, van

LUMC, Albinusdreef 2, C4-67

l.d.van_schinkel@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)