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| Name | Class |
|---|---|
| Almased Wellness GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almased | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almased | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| insulin demand per day | daily insulin dosage | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c | 12 weeks |
| body weight | body weight | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stepahn Martin, MD | West German Center of Diabetes and Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West German Center of Diabetes and Health | Düsseldorf | 40591 | Germany |
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| Label | URL |
|---|---|
| Homepage WDGZ | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |