Diabetes type 2 Obesity/overweight Diabetes type 2 Obesitas/overgewicht
Conditions
Interventions
1. Very low calorie diet + usual care
2. very low calorie diet + usual care + Combined Psychological Intervention (CPI).
The first 8 weeks, a very low calorie diet will be given, consisting of 750 calories a day. After these 8 weeks, the
Sponsors
Erasmus Medical Centre Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed diabetes mellitus type 2; 2. Age 18-70 years; 3. BMI 27 kg/m2 or more.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation during the study; 2. Inadequate expression of the Dutch language (spoken and written); 3. Inability to lose 5% or more of the bodyweight during the first 8 weeks of VLCD; 4. Severe psychiatric problems; 5. Significant cardiac arrhythmias, unstable angina, decompensated congestive heart failure, major organ system failure, untreated hypothyroidism and/or myocardial infarction, end-stage renal disease, cerebrovascular accident or major surgery in the last 3 months; 6. Absence on > 8 sessions CPI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint with respect to the efficacy of CPI, is the between-group difference in weight change (kg) measured as weight after 2 years follow-up minus weight at week 12 (directly after intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometric measurements: BMI, waist-hip-ratio, bellycircumference, body composition (%fat and lean body mass); 2. Cardiovascular riskprofile: HbA1c, HOMA241, bloodpressure, lipids profile; 3. Glycaemic control: insulin, glucose; 4. Psychological measurements: EuroQol, HADS, VOEG-13, CIS, RSE; 5. Lifestyle: SQUASH, EDE-Q; 6. Cost effectiveness: SRS, TIC-P. | — |
Contacts
Public ContactKirsten Berk
Outcome results
None listed