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Metabolic Activation With Almased for Type 2 Diabetes Patients

NCT ID: NCT01680926

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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type 2 diabetes mellitus insulin hbA1c body weight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Almased

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Almased-Vitalkost

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Almased Wellness GmbH

INDUSTRY

Sponsor Role collaborator

West German Center of Diabetes and Health

OTHER

Sponsor Role lead

Responsible Party

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Stephan Martin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stepahn Martin, MD

Role: PRINCIPAL_INVESTIGATOR

West German Center of Diabetes and Health

Locations

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West German Center of Diabetes and Health

Düsseldorf, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.vkkd-kliniken.de/zentreninstitute/gesundheits_und_therapie_centrum/westdeutsches_diabetes_und_gesundheitszentrum_wdgz/

Homepage WDGZ

Other Identifiers

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Almased100

Identifier Type: -

Identifier Source: org_study_id