xml: <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/NCT05984459</url>
    </required_header>
    <id_info>
      <org_study_id>FMH Endocrinol and Diabetol</org_study_id>
      <nct_id>NCT05984459</nct_id>
    </id_info>
    <brief_title>Type 2 Diabetes Treatment and Remission With a Very Low-calorie Ketogenic Diet (VLCKD) and Lifestyle Changes</brief_title>
    <official_title>Type 2 Diabetes Treatment and Remission With a Very Low-calorie Ketogenic Diet (VLCKD) and Lifestyle Changes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cabinet Medical</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Trialance SCCL</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Cabinet Medical</source>
    <oversight_info>
      <has_dmc>No</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>
        There is a close association between overweight, abdominal type, and type 2 diabetes mellitus&#xD;
        (T2DM).The scientific literature of recent years shows the existing relationship between&#xD;
        weight loss, of 15% or more of body weight, and the positive effect on body composition&#xD;
        parameters as well as on glycemic profiles. Specifically, here the investigator focuses on&#xD;
        very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess&#xD;
        weight and improving diabetes. Current knowledge is changing the face of T2DM, showing that&#xD;
        an effective, appropriate and early intervention can lead to a remission of diabetes&#xD;
        involving a partial recovery of insulin secretion as well as its action.&#xD;
  &#xD;
        Nevertheless, the daily life of the diabetic patient followed in an office can be less linear&#xD;
        than that of a patient participating in a study protocol, with planned follow-up visits and&#xD;
        close supervision. What about the impact of VLCKD, observed in clinical studies, in patients&#xD;
        with T2DM in real-life? In order to answer this question, we would like to analyze here a&#xD;
        series of patient files with T2DM and overweight, followed in a private practice,&#xD;
        specializing in diabetology, who have adhered to a VLCKD, by a commercial method (PnK®&#xD;
        Method), in order to improve their glycemic control.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigator wishes to carry out an observational, retrospective, uncontrolled,&#xD;
        monocentric analysis on a group of patients with overweight and type 2 diabetes mellitus&#xD;
        (T2DM).&#xD;
  &#xD;
        The analysis will focus on the observation of the evolution of anthropometric and clinical&#xD;
        parameters, such as the improvement or normalization of HbA1c, as well as on the evolution of&#xD;
        the hypoglycemic medication.&#xD;
  &#xD;
        The data collected and analyzed will correspond to 4 moments:1.T0, at the start of&#xD;
        treatment;2. T1, at the end of VLCKD, period of ketosis with an average duration of 12 weeks;&#xD;
        3.T2, after 6-9 months of support and individualized therapeutic education for a new&#xD;
        lifestyle;4. T3, after 18-24 months of usual follow-up with 1 visit every 3 to 6 months. The&#xD;
        population included in our analysis consists of adults with T2DM, with a BMI greater than 25&#xD;
        kg/m2, followed in a diabetology office. This constitutes a form of selection of the&#xD;
        population because people with more social, economic, linguistic difficulties, more complex&#xD;
        pathologies will be better taken care of in a hospital environment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 20, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Diabetes remission</measure>
      <time_frame>24 months</time_frame>
      <description>Measured as HbA1c (%)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in body weight</measure>
      <time_frame>24 months</time_frame>
      <description>Measured as kilograms (kg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body fat</measure>
      <time_frame>24 months</time_frame>
      <description>Measuared in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in visceral fat</measure>
      <time_frame>24 months</time_frame>
      <description>Measuared in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in waist circumference</measure>
      <time_frame>24 months</time_frame>
      <description>Measured in percentage (%)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Body Mass Index (BMI)</measure>
      <time_frame>24 months</time_frame>
      <description>Measured in kilogram per square meter (kg/m^2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of type 2 diabetes remissions</measure>
      <time_frame>24 months</time_frame>
      <description>Measured as count of participants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decreases in poglycemic drug treatments</measure>
      <time_frame>24 months</time_frame>
      <description>Measured as changes in the number of diabetes treatments</description>
    </secondary_outcome>
    <enrollment type="Anticipated">39</enrollment>
    <condition>Type 2 Diabetes Mellitus</condition>
    <condition>Overweight and Obesity</condition>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>VLCKD</intervention_name>
      <description>The analysis will focus on the observation of the evolution of anthropometric and clinical parameters,such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication between patients who accept VLCKD method</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A patient cohort with overweight and type 2 diabetes.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have a diagnosis of type 2 diabetes&#xD;
  &#xD;
            -  Being overweight (BMI &gt; 25 kg/m^2) or obesity (BMI &gt; 29.9 kg/m^2)&#xD;
  &#xD;
            -  Have wished to engage in a weight loss program according to the PnK® method&#xD;
  &#xD;
            -  Have accepted and signed the consent for the use of data&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Type 1 diabetes&#xD;
  &#xD;
            -  Eating disorders&#xD;
  &#xD;
            -  Psychiatric disorders&#xD;
  &#xD;
            -  Have any contraindication for doing the active or ketogenic phase&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xavier Molina, PhD</last_name>
      <phone>34689900009</phone>
      <email>xmolina@trialance.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dr. Daniela Sofra</name>
        <address>
          <city>Lausanne</city>
          <zip>1003</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xavier Molina, PhD</last_name>
        <phone>34689900009</phone>
        <email>xmolina@trialance.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Very low-calorie ketogenic diet</keyword>
    <keyword>VLCKD</keyword>
    <keyword>Type 2 diabetes</keyword>
    <keyword>Overweight</keyword>
    <keyword>Obesity</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>
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984459
  org study id: FMH Endocrinol and Diabetol
  nct id: NCT05984459
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is a close association between overweight, abdominal type, and type 2 diabetes mellitus
        (T2DM).The scientific literature of recent years shows the existing relationship between
        weight loss, of 15% or more of body weight, and the positive effect on body composition
        parameters as well as on glycemic profiles. Specifically, here the investigator focuses on
        very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess
        weight and improving diabetes. Current knowledge is changing the face of T2DM, showing that
        an effective, appropriate and early intervention can lead to a remission of diabetes
        involving a partial recovery of insulin secretion as well as its action.
  
        Nevertheless, the daily life of the diabetic patient followed in an office can be less linear
        than that of a patient participating in a study protocol, with planned follow-up visits and
        close supervision. What about the impact of VLCKD, observed in clinical studies, in patients
        with T2DM in real-life? In order to answer this question, we would like to analyze here a
        series of patient files with T2DM and overweight, followed in a private practice,
        specializing in diabetology, who have adhered to a VLCKD, by a commercial method (PnK®
        Method), in order to improve their glycemic control.
  The investigator wishes to carry out an observational, retrospective, uncontrolled,
        monocentric analysis on a group of patients with overweight and type 2 diabetes mellitus
        (T2DM).
  
        The analysis will focus on the observation of the evolution of anthropometric and clinical
        parameters, such as the improvement or normalization of HbA1c, as well as on the evolution of
        the hypoglycemic medication.
  
        The data collected and analyzed will correspond to 4 moments:1.T0, at the start of
        treatment;2. T1, at the end of VLCKD, period of ketosis with an average duration of 12 weeks;
        3.T2, after 6-9 months of support and individualized therapeutic education for a new
        lifestyle;4. T3, after 18-24 months of usual follow-up with 1 visit every 3 to 6 months. The
        population included in our analysis consists of adults with T2DM, with a BMI greater than 25
        kg/m2, followed in a diabetology office. This constitutes a form of selection of the
        population because people with more social, economic, linguistic difficulties, more complex
        pathologies will be better taken care of in a hospital environment.
  observational model: Cohort
  time perspective: Retrospective
  measure: Diabetes remission
  time frame: 24 months
  description: Measured as HbA1c (%)
  measure: Change in body weight
  time frame: 24 months
  description: Measured as kilograms (kg)
  measure: Change in body fat
  time frame: 24 months
  description: Measuared in percentage (%)
  measure: Change in visceral fat
  time frame: 24 months
  description: Measuared in percentage (%)
  measure: Change in waist circumference
  time frame: 24 months
  description: Measured in percentage (%)
  measure: Change in Body Mass Index (BMI)
  time frame: 24 months
  description: Measured in kilogram per square meter (kg/m^2)
  measure: Number of type 2 diabetes remissions
  time frame: 24 months
  description: Measured as count of participants
  measure: Decreases in poglycemic drug treatments
  time frame: 24 months
  description: Measured as changes in the number of diabetes treatments
  intervention type: Dietary Supplement
  intervention name: VLCKD
  description: The analysis will focus on the observation of the evolution of anthropometric and clinical parameters,such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication between patients who accept VLCKD method
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xavier Molina, PhD
  phone: 34689900009
  email: xmolina@trialance.com
  facility: 
  status: Recruiting
  contact: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Overweight
  sharing ipd: Undecided