<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/NCT02230501</url>
  </required_header>
  <id_info>
    <org_study_id>AVS</org_study_id>
    <nct_id>NCT02230501</nct_id>
  </id_info>
  <brief_title>Metabolic Activation With Protein-rich Formula Diet</brief_title>
  <acronym>AVS</acronym>
  <official_title>Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial</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>
      Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT&#xD;
      01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin&#xD;
      demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting &gt;100 IE&#xD;
      insulin/day. The aim of the present study was to investigate in a randomized-controlled trial&#xD;
      if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or&#xD;
      insulin.&#xD;
&#xD;
      A second part of the study is an open-label registry for persons with type 2 diabetes, who&#xD;
      will perform the lifestyle intervention with the stringent diet regime.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st&#xD;
      week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR&#xD;
      (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In&#xD;
      2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week&#xD;
      only dinner was replaced. The control group with moderate diet regime replaced breakfast and&#xD;
      dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were&#xD;
      determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was&#xD;
      reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.&#xD;
&#xD;
      In the second part of the study type 2 diabetes patients are included in an open-label&#xD;
      reistry and perform the lifestyle intervention with the stringent diet regime.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 2011</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>For the second part of the study, i.e. the open-label registry, there ist no randomization.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>For the second part of the study, i.e. the open-label registry, 4000 subjects are anicipated.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>change in hemoglobin A1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>1 year</time_frame>
    <description>change in hemoglobin A1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body weight</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cholesterol</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in total cholesterol change in HDL cholesterol change in LDL cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fasting blood glucose</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in fastin g blood glucose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nutrition</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in FEV (questionnaire for eating manners)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>change in physical activity questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antidiabetic medication</measure>
    <time_frame>12 weeks and 1 year</time_frame>
    <description>absolute amount of antidiabetic medication&#xD;
increase or reduction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>moderate diet regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner&#xD;
For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stringent diet regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner&#xD;
For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>stringent diet regimen</intervention_name>
    <arm_group_label>stringent diet regimen</arm_group_label>
    <other_name>protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>moderate diet regimen</intervention_name>
    <arm_group_label>moderate diet regimen</arm_group_label>
    <other_name>protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus&#xD;
&#xD;
          -  HbA1c &gt; 7,5%&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 27,5 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute infections&#xD;
&#xD;
          -  severe diseased with hospital stay during the last 3 months&#xD;
&#xD;
          -  chronic diseases&#xD;
&#xD;
          -  chemotherapy or cortisone treatment&#xD;
&#xD;
          -  weight loss of more than 2 kg per week during the last month&#xD;
&#xD;
          -  smoking cessation during the last 3 months or planned&#xD;
&#xD;
          -  weight-influencing medication&#xD;
&#xD;
          -  pregnancy, breast-feeding or lack of contraception&#xD;
&#xD;
          -  high-level physical activity of more than 1h per day&#xD;
&#xD;
          -  incompatibility with components of the PRMR&#xD;
&#xD;
          -  participation in an other study during the last 6 months&#xD;
&#xD;
        For the open-label registry, the only inclusion criterium is type 2 diabetes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West German Centre 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>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2022</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02230501
org study id: AVS
nct id: NCT02230501
lead sponsor: 
collaborator: 
has dmc: No
Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT
      01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin
      demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE
      insulin/day. The aim of the present study was to investigate in a randomized-controlled trial
      if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or
      insulin.

      A second part of the study is an open-label registry for persons with type 2 diabetes, who
      will perform the lifestyle intervention with the stringent diet regime.
Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st
      week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR
      (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In
      2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week
      only dinner was replaced. The control group with moderate diet regime replaced breakfast and
      dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were
      determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was
      reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.

      In the second part of the study type 2 diabetes patients are included in an open-label
      reistry and perform the lifestyle intervention with the stringent diet regime.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: For the second part of the study, i.e. the open-label registry, there ist no randomization.
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: For the second part of the study, i.e. the open-label registry, 4000 subjects are anicipated.
measure: HbA1c
time frame: 12 weeks
description: change in hemoglobin A1c
measure: HbA1c
time frame: 1 year
description: change in hemoglobin A1c
measure: body weight
time frame: 12 weeks and 1 year
description: change in body weight
measure: blood pressure
time frame: 12 weeks and 1 year
description: change in systolic and diastolic blood pressure
measure: cholesterol
time frame: 12 weeks and 1 year
description: change in total cholesterol change in HDL cholesterol change in LDL cholesterol
measure: fasting blood glucose
time frame: 12 weeks and 1 year
description: change in fastin g blood glucose
measure: quality of life
time frame: 12 weeks and 1 year
description: change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale)
measure: nutrition
time frame: 12 weeks and 1 year
description: change in FEV (questionnaire for eating manners)
measure: physical activity
time frame: 12 weeks and 1 year
description: change in physical activity questionnaire
measure: antidiabetic medication
time frame: 12 weeks and 1 year
description: absolute amount of antidiabetic medication
increase or reduction
arm group label: moderate diet regimen
arm group type: Experimental
description: Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner
For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.
arm group label: stringent diet regimen
arm group type: Experimental
description: Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner
For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned.
intervention type: Dietary Supplement
intervention name: stringent diet regimen
arm group label: stringent diet regimen
other name: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)
intervention type: Dietary Supplement
intervention name: moderate diet regimen
arm group label: moderate diet regimen
other name: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)
criteria: 
gender: All
minimum age: 25 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Germany
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, Type 2