Metabolic Activation With Almased for Type 2 Diabetes Patients

Type 2 Diabetes Mellitus Clinical Trial

— Almased100  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680926
• Other study ID #: Almased100
• Status: Completed
• Phase: Phase 0
• First received: September 4, 2012
• Last updated: September 9, 2012
• Start date: July 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2012
• Source: West German Center of Diabetes and Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Almased
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.

Locations

Country	Name	City	State
Germany	West German Center of Diabetes and Health	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health	Almased Wellness GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin demand per day	daily insulin dosage	12 weeks	No
Secondary	HbA1c	HbA1c	12 weeks	No
Secondary	body weight	body weight	12 weeks	No

External Links

•   Homepage WDGZ