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/NCT05990205</url>
    </required_header>
    <id_info>
      <org_study_id>2579</org_study_id>
      <nct_id>NCT05990205</nct_id>
    </id_info>
    <brief_title>Effect of the SCL16A11 Risk Haplotype on Treatments to Prevent Type 2 Diabetes</brief_title>
    <acronym>PRED2</acronym>
    <official_title>Effect of the Genetic Variants Typical of the Mestizo Population That Confer Risk of Having Metabolic Diseases on the Response to Common Treatments (Diet, Physical Activity, Metformin, Exercise).</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized clinical trial is to determine the impact of the risk haplotype&#xD;
        on SLC16A11 on early therapeutic responses in treatments to prevent T2D in Mexican mestizos&#xD;
        with prediabetes. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Evaluate the effect of the risk haplotype on weigth loss &gt;3%&#xD;
  &#xD;
          -  Evualuate the differences in lipid profiles and glycemic parameters (fasting glucose,&#xD;
             HbA1c).&#xD;
  &#xD;
        Participants will be randomized into two groups: lifestyle intervention (LSI): hypocaloric&#xD;
        diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and&#xD;
        25% protein sources + physical activity (&gt;150 min medium intensity per week), or LSI + MET&#xD;
        (750 mg metformin twice a day).&#xD;
  &#xD;
        Researchers will compare carriers and non carriers of the risk haplotype of SLC16A11 to see&#xD;
        if there are diferent treatment responses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives: Dietary modification and/or metformin remain the most cost-effective treatment to&#xD;
        prevent type 2 diabetes (T2D). Yet, there is an important variation in receiving the benefit&#xD;
        among individuals. A haplotype in SLC16A11 is associated with decreased insulin action and&#xD;
        risk for T2D in Mexicans. We aim to determine the impact of the risk haplotype on SLC16A11 on&#xD;
        early therapeutic responses in treatments to prevent T2D.&#xD;
  &#xD;
        Methods: We recrute individuals with at least one prediabetes criteria according to the&#xD;
        American Diabetes Association with a body mass index (BMI) between 25 and 45 kg/m2.&#xD;
        Participants are randomized into two groups: lifestyle intervention (LSI): hypocaloric diet,&#xD;
        25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25%&#xD;
        protein sources + physical activity (&gt;150 min medium intensity per week), or LSI + MET (750&#xD;
        mg metformin twice a day). Standardized dietitians delivere the LSI. The treatment goal is to&#xD;
        achieve &gt;3% weight loss during the 12-week follow-up. Participants are genotyped for the risk&#xD;
        allele rs13342232 and rs75493593. The effects of the risk haplotype are evaluated with linear&#xD;
        and logistic regressions adjusted by age, sex, five genetic principal components, BMI, and&#xD;
        prediabetes criteria at baseline. Primary outcome is a significant interaction between the&#xD;
        treatment arm and genotype in weight loss goal &gt;3% after the treatment. Secondary outcome are&#xD;
        differences in lipid levels and third outcome is differences in glycemic parameters (fasting&#xD;
        glucose, HbA1c).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 17, 2018</start_date>
    <completion_date type="Anticipated">May 25, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 20, 2023</primary_completion_date>
    <phase>Phase 2</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in weigth loss</measure>
      <time_frame>12 weeks</time_frame>
      <description>Number of participants in each treatment arm reaching the the goal weight loss &gt;3%</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Total-Cholesterol parameters</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decreasing concentration of Total-Cholesterol (mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in LDL-Cholesterol parameters</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decreasing LDL-Cholesterol levels (mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ApoB</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decreasing ApoB levels (mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in NonHDL-Cholesterol</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decreasin NonHDL-Cholesterol levels (mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fasting glucose</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decreasing fasting glucose levels (mg/dl)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HbA1c</measure>
      <time_frame>12 weeks</time_frame>
      <description>Decreasin HbA1c levels (%)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">437</enrollment>
    <condition>PreDiabetes</condition>
    <arm_group>
      <arm_group_label>Life Style Intervention</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (&gt;150 min medium intensity per week)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Life Style Intervention + Metformin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (&gt;150 min medium intensity per week) + (750 mg metformin twice a day).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Life Style Intervention + Metformin</intervention_name>
      <description>hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (&gt;150 min medium intensity per week) + Metformin extended release 750mg each 12 hours</description>
      <arm_group_label>Life Style Intervention + Metformin</arm_group_label>
      <other_name>LSI + MET</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Life Style Intervention</intervention_name>
      <description>hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (&gt;150 min medium intensity per week)</description>
      <arm_group_label>Life Style Intervention</arm_group_label>
      <other_name>LSI</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Mexican mestizos&#xD;
  &#xD;
            -  At least one prediabetes criteria according to the American Diabetes Association:&#xD;
               fasting glucose between 100-124 mg/dL, Glycosylated hemoglobin (HbA1c) between&#xD;
               5.7-6.4, and 2-hour blood sugar between 140 mg/dl-199 mg/dl after an oral load of 75g&#xD;
               of glucose) (1);&#xD;
  &#xD;
            -  Age ranged between 18-65 years&#xD;
  &#xD;
            -  Overweight or obesity (BMI between 25.0 - 40 kg/m2).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Chronic diseases&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Chronic use of medications that altered plasma glucose levels.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Carlos A Aguilar Salinas, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paloma Almeda Valdez, PhD</last_name>
      <phone>55 5487 0900</phone>
      <phone_ext>6321</phone_ext>
      <email>palomaalmeda@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Donaji V Gomez Velazco, MD</last_name>
      <phone>55 5487 0900</phone>
      <phone_ext>6321</phone_ext>
      <email>donajivgv@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán</name>
        <address>
          <city>Mexico City</city>
          <zip>14080</zip>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Donají Gomez Velasco, MPH</last_name>
        <phone>55 5487 0900</phone>
        <phone_ext>6321</phone_ext>
        <email>donaji.gomezv@incmnsz.mx</email>
      </contact>
    </location>
    <location_countries>
      <country>Mexico</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PreDiabetes</keyword>
    <keyword>Metformin</keyword>
    <keyword>Precision nutrition</keyword>
    <keyword>SLC16A11</keyword>
    <keyword>Mexican Mestizos</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
      <mesh_term>Glucose Intolerance</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metformin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data will be shared upon request to authorized researchers</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be made available to the broader scientific community within six months of publication or within 18 months of the conclusion of the funding period if the study remains unpublished.</ipd_time_frame>
      <ipd_access_criteria>Per International standards, we will require from any investigator or entity requesting the data a data-sharing agreement that provides (1) a commitment to using the data only for research purposes and not to identify any individual participants, (2) a commitment to securing the data using appropriate computer technology, and (3) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
    </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/NCT05990205
  org study id: 2579
  nct id: NCT05990205
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this randomized clinical trial is to determine the impact of the risk haplotype
        on SLC16A11 on early therapeutic responses in treatments to prevent T2D in Mexican mestizos
        with prediabetes. The main question[s] it aims to answer are:
  
          -  Evaluate the effect of the risk haplotype on weigth loss >3%
  
          -  Evualuate the differences in lipid profiles and glycemic parameters (fasting glucose,
             HbA1c).
  
        Participants will be randomized into two groups: lifestyle intervention (LSI): hypocaloric
        diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and
        25% protein sources + physical activity (>150 min medium intensity per week), or LSI + MET
        (750 mg metformin twice a day).
  
        Researchers will compare carriers and non carriers of the risk haplotype of SLC16A11 to see
        if there are diferent treatment responses.
  Objectives: Dietary modification and/or metformin remain the most cost-effective treatment to
        prevent type 2 diabetes (T2D). Yet, there is an important variation in receiving the benefit
        among individuals. A haplotype in SLC16A11 is associated with decreased insulin action and
        risk for T2D in Mexicans. We aim to determine the impact of the risk haplotype on SLC16A11 on
        early therapeutic responses in treatments to prevent T2D.
  
        Methods: We recrute individuals with at least one prediabetes criteria according to the
        American Diabetes Association with a body mass index (BMI) between 25 and 45 kg/m2.
        Participants are randomized into two groups: lifestyle intervention (LSI): hypocaloric diet,
        25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25%
        protein sources + physical activity (>150 min medium intensity per week), or LSI + MET (750
        mg metformin twice a day). Standardized dietitians delivere the LSI. The treatment goal is to
        achieve >3% weight loss during the 12-week follow-up. Participants are genotyped for the risk
        allele rs13342232 and rs75493593. The effects of the risk haplotype are evaluated with linear
        and logistic regressions adjusted by age, sex, five genetic principal components, BMI, and
        prediabetes criteria at baseline. Primary outcome is a significant interaction between the
        treatment arm and genotype in weight loss goal >3% after the treatment. Secondary outcome are
        differences in lipid levels and third outcome is differences in glycemic parameters (fasting
        glucose, HbA1c).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in weigth loss
  time frame: 12 weeks
  description: Number of participants in each treatment arm reaching the the goal weight loss >3%
  measure: Change in Total-Cholesterol parameters
  time frame: 12 weeks
  description: Decreasing concentration of Total-Cholesterol (mg/dl)
  measure: Change in LDL-Cholesterol parameters
  time frame: 12 weeks
  description: Decreasing LDL-Cholesterol levels (mg/dl)
  measure: Change in ApoB
  time frame: 12 weeks
  description: Decreasing ApoB levels (mg/dl)
  measure: Change in NonHDL-Cholesterol
  time frame: 12 weeks
  description: Decreasin NonHDL-Cholesterol levels (mg/dl)
  measure: Change in fasting glucose
  time frame: 12 weeks
  description: Decreasing fasting glucose levels (mg/dl)
  measure: Change in HbA1c
  time frame: 12 weeks
  description: Decreasin HbA1c levels (%)
  arm group label: Life Style Intervention
  arm group type: Active Comparator
  description: Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week)
  arm group label: Life Style Intervention + Metformin
  arm group type: Active Comparator
  description: Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week) + (750 mg metformin twice a day).
  intervention type: Drug
  intervention name: Life Style Intervention + Metformin
  description: hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week) + Metformin extended release 750mg each 12 hours
  arm group label: Life Style Intervention + Metformin
  other name: LSI + MET
  intervention type: Behavioral
  intervention name: Life Style Intervention
  description: hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (>150 min medium intensity per week)
  arm group label: Life Style Intervention
  other name: LSI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Carlos A Aguilar Salinas, PhD
  role: Principal Investigator
  affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  last name: Paloma Almeda Valdez, PhD
  phone: 55 5487 0900
  phone ext: 6321
  email: palomaalmeda@yahoo.com
  last name: Donaji V Gomez Velazco, MD
  phone: 55 5487 0900
  phone ext: 6321
  email: donajivgv@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Mexico
  responsible party type: Sponsor
  mesh term: Prediabetic State
  mesh term: Glucose Intolerance
  mesh term: Metformin
  sharing ipd: Yes
  ipd description: De-identified data will be shared upon request to authorized researchers
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Data will be made available to the broader scientific community within six months of publication or within 18 months of the conclusion of the funding period if the study remains unpublished.
  ipd access criteria: Per International standards, we will require from any investigator or entity requesting the data a data-sharing agreement that provides (1) a commitment to using the data only for research purposes and not to identify any individual participants, (2) a commitment to securing the data using appropriate computer technology, and (3) a commitment to destroying or returning the data after analyses are completed.