Metabolic Activation With Almased for Type 2 Diabetes Patients (Almased100)

West German Center of Diabetes and Health

Status and phase: Completed; Early Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Almased

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01680926

Almased100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Almased

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Almased