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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Almased
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring type 2 diabetes mellitus, insulin, hbA1c, body weight

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West German Center of Diabetes and Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Almased

Arm Description

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.

Outcomes

Primary Outcome Measures

insulin demand per day
daily insulin dosage

Secondary Outcome Measures

HbA1c
HbA1c
body weight
body weight

Full Information

First Posted
September 4, 2012
Last Updated
September 9, 2012
Sponsor
West German Center of Diabetes and Health
Collaborators
Almased Wellness GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01680926
Brief Title
Metabolic Activation With Almased for Type 2 Diabetes Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
Almased Wellness GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
type 2 diabetes mellitus, insulin, hbA1c, body weight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Almased
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Almased
Other Intervention Name(s)
Almased-Vitalkost
Intervention Description
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 Measure Information:
Title
insulin demand per day
Description
daily insulin dosage
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Description
HbA1c
Time Frame
12 weeks
Title
body weight
Description
body weight
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stepahn Martin, MD
Organizational Affiliation
West German Center of Diabetes and Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
West German Center of Diabetes and Health
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.vkkd-kliniken.de/zentreninstitute/gesundheits_und_therapie_centrum/westdeutsches_diabetes_und_gesundheitszentrum_wdgz/
Description
Homepage WDGZ

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Metabolic Activation With Almased for Type 2 Diabetes Patients

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