<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01680926</url>
  </required_header>
  <id_info>
    <org_study_id>Almased100</org_study_id>
    <nct_id>NCT01680926</nct_id>
  </id_info>
  <brief_title>Metabolic Activation With Almased for Type 2 Diabetes Patients</brief_title>
  <acronym>Almased100</acronym>
  <official_title>Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and &gt;100 U Insulin Per Day</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West German Center of Diabetes and Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Almased Wellness GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>West German Center of Diabetes and Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overweight patients with type 2 diabetes are often being treated with an intensified insulin&#xD;
      therapy. However, in many cases, even a high insulin dosage (&gt; 100 U per day) does not&#xD;
      achieve satisfying metabolic control. A new therapy option is necessary that makes it&#xD;
      possible to lower the daily insulin requirement and to improve metabolic control. The aim of&#xD;
      this study was to investigate whether a protein-rich meal replacement is suitable to lower&#xD;
      the daily insulin requirement and to reduce HbA1c and body weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pilot study included patients with type 2 diabetes (n=22), that injected &gt;100 U insulin&#xD;
      daily. During the first week, all three main meals were replaced with 50 g of a protein-rich&#xD;
      meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were&#xD;
      replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.&#xD;
      Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as&#xD;
      well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the&#xD;
      intention-to-treat analysis and Mann-Whitney test for subgroup analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">February 2011</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>insulin demand per day</measure>
    <time_frame>12 weeks</time_frame>
    <description>daily insulin dosage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>body weight</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Almased</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Almased</intervention_name>
    <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.</description>
    <arm_group_label>Almased</arm_group_label>
    <other_name>Almased-Vitalkost</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with type 2 diabetes&#xD;
&#xD;
          -  BMI &gt; 27 kg/m2&#xD;
&#xD;
          -  age 35-75 years&#xD;
&#xD;
          -  insulin therapy &gt;100 U insulin per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication for a calorie reduced diet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stepahn Martin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West German Center of Diabetes and Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West German Center of Diabetes and Health</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40591</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.vkkd-kliniken.de/zentreninstitute/gesundheits_und_therapie_centrum/westdeutsches_diabetes_und_gesundheitszentrum_wdgz/</url>
    <description>Homepage WDGZ</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 9, 2012</last_update_submitted>
  <last_update_submitted_qc>September 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West German Center of Diabetes and Health</investigator_affiliation>
    <investigator_full_name>Stephan Martin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>insulin</keyword>
  <keyword>hbA1c</keyword>
  <keyword>body weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680926
org study id: Almased100
nct id: NCT01680926
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: insulin demand per day
time frame: 12 weeks
description: daily insulin dosage
measure: HbA1c
time frame: 12 weeks
description: HbA1c
measure: body weight
time frame: 12 weeks
description: body weight
arm group label: Almased
arm group type: Experimental
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: Almased
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.
arm group label: Almased
other name: Almased-Vitalkost
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Stepahn Martin, MD
role: Principal Investigator
affiliation: West German Center of Diabetes and Health
facility: 
country: Germany
url: http://www.vkkd-kliniken.de/zentreninstitute/gesundheits_und_therapie_centrum/westdeutsches_diabetes_und_gesundheitszentrum_wdgz/
description: Homepage WDGZ
responsible party type: Principal Investigator
investigator affiliation: West German Center of Diabetes and Health
investigator full name: Stephan Martin
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2