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

September 9, 2012 updated by: Stephan Martin, West German Center of Diabetes and Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40591
        • West German Center of Diabetes and Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Almased-Vitalkost

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 12 weeks
HbA1c
12 weeks
body weight
Time Frame: 12 weeks
body weight
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Center of Diabetes and Health

Collaborators

Almased Wellness GmbH

Investigators

  • Principal Investigator: Stepahn Martin, MD, West German Center of Diabetes and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 9, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Almased100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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