Metabolic Activation With Almased for Type 2 Diabetes Patients

Early Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Almased

• Registration Number: NCT01680926
• Lead Sponsor: West German Center of Diabetes and Health

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-02
• Study Completion: 2011-10
• Status Verified: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-07
• Last Update Submitted: 2012-09-09
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Almased	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.

Primary Outcome Measures

Name	Time	Method
insulin demand per day	12 weeks	daily insulin dosage

Secondary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	HbA1c
body weight	12 weeks	body weight

Trial Locations

Locations (1)

West German Center of Diabetes and Health; 🇩🇪 Düsseldorf, Germany