Metabolic Activation With Almased for Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and >100 U Insulin Per Day

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Almased


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almased<br>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. | Dietary Supplement: Almased<br>* 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.<br>* Other names: Almased-Vitalkost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin demand per day | daily insulin dosage | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c | 12 weeks | 
| body weight | body weight | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes mellitus, insulin, hbA1c, body weight