Type 2 Diabetes Mellitus
Conditions
Keywords
type 2 diabetes mellitus, insulin, hbA1c, body weight
Brief summary
Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (\> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.
Detailed description
The pilot study included patients with type 2 diabetes (n=22), that injected \>100 U insulin daily. During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.
Interventions
During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
Sponsors
Study design
Eligibility
Inclusion criteria
* patients with type 2 diabetes * BMI \> 27 kg/m2 * age 35-75 years * insulin therapy \>100 U insulin per day
Exclusion criteria
* contraindication for a calorie reduced diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insulin demand per day | 12 weeks | daily insulin dosage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | HbA1c |
| body weight | 12 weeks | body weight |
Countries
Germany