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

Effects of a VLCD in obese patients with type 2 diabetes and cardiovascular complications - VLCD in patients with DM2 and cardiovascular complications

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34522

Enrollment

Registered

2011-02-15

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

Diabetes Diabetes Mellitus

Interventions

All patients will receive a VLCD consisting of 4-6 meal replacements (cold and warm meal replacements) every day of Prodimed. This diet contains 400-600 kcal/day. Dependent on the amount of weigth l

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Any significant chronic disease, except DM2 Renal, hepatic or another endocrine disease Signs of a septal myocardial infarction Pregnancy Congenital heart disease MRI contra-indications

Design outcomes

Primary

Measure	Time frame
Main Parameters: Anthropometric: weight, height, waist and hip circumference Plasma concentrations: glucose, insulin, glucagon, FFA, HDL, VLDL, LDL, triglycerides MRI: Heart dimensions Heart function Heart valve flow Body fat distribution Aortic Pulse wave velocity Magnetic resonance spectroscopy: ¹H-MR spectroscopy of the heart and liver - Triglyceride content	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)