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

West German Center of Diabetes and Health1 site in 1 country22 target enrollmentJuly 2009

ConditionsType 2 Diabetes Mellitus

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: West German Center of Diabetes and Health
Enrollment: 22
Locations: 1
Primary Endpoint: insulin demand per day
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

October 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group