<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/NCT03811587</url>
  </required_header>
  <id_info>
    <org_study_id>NL63892.058.18 - P18.049</org_study_id>
    <nct_id>NCT03811587</nct_id>
  </id_info>
  <brief_title>Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes</brief_title>
  <official_title>Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dutch Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Holland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IFOM ETS - The AIRC Institute of Molecular Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>L-Nutra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this randomized, controlled, assessor blinded and prospective intervention study the&#xD;
      investigators will evaluate the clinical feasibility and effectiveness of intermittent use of&#xD;
      a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27,&#xD;
      who are treated with diet only and have a HbA1c &gt; 48, or who are treated with diet and a dose&#xD;
      of metformin can participate in the study. Participants will use a fasting-mimicking diet for&#xD;
      5 consecutive days per month. For the other days, there are no regulations. During follow-up&#xD;
      of one year, several study parameters will be measured including HbA1c and antidiabetic&#xD;
      medication dosage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">August 6, 2021</completion_date>
  <primary_completion_date type="Actual">August 6, 2021</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>Patients will be randomised to the intervention or control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Only measurements by assessors will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of HbA1c</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage of antidiabetic medication used</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Diabetes type 2 patients will take a fasting mimicking diet of 5 consecutive days a month, for a duration of 12 months. Besides this, they will receive usual diabetes care from the general practitioner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fasting Mimicking diet</intervention_name>
    <description>The fasting mimicking diet is though to activate the metabolism as fasting would do, although the diet does include several meals a day and more calories than conventional fasting diets.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 2 diabetes&#xD;
&#xD;
          -  Age &gt; 17 years and &lt;75 years&#xD;
&#xD;
          -  Treatment with diet only and have a HbA1c &gt; 48, or treatment with diet and metformin&#xD;
&#xD;
          -  BMI ≥ 27&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent myocardial infarction (&lt; 6 months)&#xD;
&#xD;
          -  Creatinine clearance &lt; 30 ml/min/1,73m2 (MDRD)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindications for MRI&#xD;
&#xD;
          -  Allergy for nuts, sesame, soya or another ingredient of the diet&#xD;
&#xD;
          -  History of syncope with calorie restriction in the past&#xD;
&#xD;
          -  Any significant other disease (at the discretion of the investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanno Pijl, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden Univerity Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leiden University Medical Centre</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>Hanno Pijl</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Diet</keyword>
  <keyword>Fasting</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/NCT03811587
org study id: NL63892.058.18 - P18.049
nct id: NCT03811587
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this randomized, controlled, assessor blinded and prospective intervention study the
      investigators will evaluate the clinical feasibility and effectiveness of intermittent use of
      a fasting mimicking diet in patients with type 2 diabetes mellitus compared to usual care.
100 individuals (men or women, ethnicity not specified) with type 2 diabetes and a BMI≥ 27,
      who are treated with diet only and have a HbA1c > 48, or who are treated with diet and a dose
      of metformin can participate in the study. Participants will use a fasting-mimicking diet for
      5 consecutive days per month. For the other days, there are no regulations. During follow-up
      of one year, several study parameters will be measured including HbA1c and antidiabetic
      medication dosage.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomised to the intervention or control group.
primary purpose: Treatment
masking: None (Open Label)
masking description: Only measurements by assessors will be blinded.
measure: Concentration of HbA1c
time frame: 12 months
measure: Dosage of antidiabetic medication used
time frame: 12 months
arm group label: Treatment group
arm group type: Experimental
description: Diabetes type 2 patients will take a fasting mimicking diet of 5 consecutive days a month, for a duration of 12 months. Besides this, they will receive usual diabetes care from the general practitioner.
arm group label: Control group
arm group type: No Intervention
description: Diabetes type 2 Patients will have no intervention, they will receive usual diabetes care from the general practitioner.
intervention type: Other
intervention name: Fasting Mimicking diet
description: The fasting mimicking diet is though to activate the metabolism as fasting would do, although the diet does include several meals a day and more calories than conventional fasting diets.
arm group label: Treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Hanno Pijl, MD, PhD
role: Principal Investigator
affiliation: Leiden Univerity Medical Centre
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: Hanno Pijl
investigator title: Clinical Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2