Metabolic Activation With Protein-rich Formula Diet (AVS)
Type 2 Diabetes Mellitus
About this trial
This is an interventional supportive care trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus
- HbA1c > 7,5%
- Body Mass Index (BMI) ≥ 27,5 kg/m2
Exclusion Criteria:
- acute infections
- severe diseased with hospital stay during the last 3 months
- chronic diseases
- chemotherapy or cortisone treatment
- weight loss of more than 2 kg per week during the last month
- smoking cessation during the last 3 months or planned
- weight-influencing medication
- pregnancy, breast-feeding or lack of contraception
- high-level physical activity of more than 1h per day
- incompatibility with components of the PRMR
- participation in an other study during the last 6 months
For the open-label registry, the only inclusion criterium is type 2 diabetes.
Sites / Locations
- West German Centre of Diabetes and Health
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
moderate diet regimen
stringent diet regimen
Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.
Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.