<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/NCT04463160</url>
  </required_header>
  <id_info>
    <org_study_id>2018/CHU/06</org_study_id>
    <secondary_id>2018-A03106-49</secondary_id>
    <nct_id>NCT04463160</nct_id>
  </id_info>
  <brief_title>Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island.</brief_title>
  <acronym>PREDIABRUN</acronym>
  <official_title>Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the &quot;Say No to Diabetes&quot; Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</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>
      The management of diabetes and its complications in Reunion island is one of the priority&#xD;
      areas of health. Indeed, the impact of diabetes on the health of the Reunion island&#xD;
      population is major: the prevalence of diabetes treated in Reunion island is the highest in&#xD;
      France (10% of the population), and gestational diabetes is found in 10% of pregnancies.&#xD;
      Reunionese diabetics develop severe complications, in particular cardiovascular (strokes,&#xD;
      myocardial infarction).&#xD;
&#xD;
      This results in 3 times higher mortality linked to diabetes on Reunion Island, in particular&#xD;
      among those under 65 years of age. Despite all the screening and prevention programs put in&#xD;
      place, the weight of diabetic disease continues to increase in our island, and this is more&#xD;
      accelerated than in the other French departments with 4,300 new cases of diabetes / year, 95%&#xD;
      of which type 2 diabetics (T2D). The presentation of type 2 diabetic patients in Reunion&#xD;
      island also differs from the Metropolis with subjects more often female (56%), thinner and&#xD;
      younger at the discovery of diabetes. These data highlight the need to better understand the&#xD;
      factors underlying the diabetes &quot;epidemic&quot; in Reunion island.&#xD;
&#xD;
      The rise in blood sugar until the onset of diabetes is a continuous phenomenon reflecting the&#xD;
      progressive suffering of the organs used to maintain carbohydrate homeostasis. Thus, we talk&#xD;
      about fasting hyperglycemia when the fasting blood sugar is between 1.10 and 1.25 g / L&#xD;
      (6.1-6.9 mmol / l) and glucose intolerance when the blood sugar 2 hours after taking 75 g of&#xD;
      glucose is between 1.40 and 1.99 g / L (7.8-11.0 mmol / l). Subjects with fasting&#xD;
      hyperglycemia or glucose intolerance constitute the target population at very high risk of&#xD;
      developing diabetes (up to 70% of these subjects). They have an increased risk of developing&#xD;
      diabetes at 1 year multiplied by 5 to 10 compared to normoglycemic subjects, hence the name&#xD;
      &quot;prediabetic subjects&quot;. This great variability in the risk of developing diabetes highlights&#xD;
      the presence of associated risk / protective factors which it is important to find in order&#xD;
      to adapt the monitoring and management. It is important in Reunion island, in view of the&#xD;
      specificities presented by our population, to understand the pre-diabetes / diabetes&#xD;
      transition and the risk and protective factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 18, 2019</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The impact of the &quot;Say No to Diabetes&quot; intervention on the incidence of type 2 diabetes</measure>
    <time_frame>2 years</time_frame>
    <description>Diabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic</measure>
    <time_frame>2 years</time_frame>
    <description>Prediabetes : fasting blood sugar is between 1.10 and 1.25 g / l (6.1 and 6.9 mmol / l) or a blood sugar level is between 1.40 and 1.99 g / l (7.8 and 11 0.0 mmol / l) 2 hours after taking 75g of glucose (HGPO test) Diabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients return to normal blood sugar</measure>
    <time_frame>2 years</time_frame>
    <description>Normal blood sugar : fasting blood glucose &lt;1.10 g / l (6.1mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO &lt;1.40g / l (7.8 mmol / l).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO</measure>
    <time_frame>2 years</time_frame>
    <description>HbA1c assay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>prevention program for prediabetes &quot;Say No to Diabetes&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No prevention program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>prevention program for prediabetes &quot;Say No to Diabetes&quot;</intervention_name>
    <description>10 therapeutic education sessions</description>
    <arm_group_label>prevention program for prediabetes &quot;Say No to Diabetes&quot;</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject aged 25 to 70 with pre-diabetes defined by fasting blood sugar between 1.10&#xD;
             and 1.25 g / l (6.1 and 6.9 mmol / l) or blood sugar between 1.40 and 1.99 g / l (7.8&#xD;
             and 11.0 mmol / l) 2 hours after taking 75g of glucose (HGPO test), dating from less&#xD;
             than 3 months.&#xD;
&#xD;
          -  Consulting one of the general practitioners involved in the study, whatever the&#xD;
             initial reason for the consultation&#xD;
&#xD;
          -  able to answer a telephone survey questionnaire&#xD;
&#xD;
          -  who have never been diagnosed or treated for diabetes with the exception of&#xD;
             gestational diabetes&#xD;
&#xD;
          -  Person affiliated or beneficiary of a social security scheme.&#xD;
&#xD;
          -  Free, informed and written consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People likely to leave Reunion within 2 years&#xD;
&#xD;
          -  Persons placed under guardianship, curators, safeguard of justice, person&#xD;
             participating in another research including an exclusion period still in progress.&#xD;
&#xD;
          -  Person with severely impaired physical and / or psychological health, who, according&#xD;
             to the investigator, may affect the compliance of the study participant.&#xD;
&#xD;
          -  Pregnancy in progress&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Samir MEDJANE</last_name>
    <phone>0262359750</phone>
    <phone_ext>+262</phone_ext>
    <email>samir.medjane@chu-reunion.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de la Réunion</name>
      <address>
        <city>Saint-Pierre</city>
        <zip>97448</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samir MEDJANE</last_name>
      <email>samir.medjane@chu-reunion.fr</email>
    </contact>
    <investigator>
      <last_name>Estelle NOBECOURT, PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463160
org study id: 2018/CHU/06
secondary id: 2018-A03106-49
nct id: NCT04463160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of diabetes and its complications in Reunion island is one of the priority
      areas of health. Indeed, the impact of diabetes on the health of the Reunion island
      population is major: the prevalence of diabetes treated in Reunion island is the highest in
      France (10% of the population), and gestational diabetes is found in 10% of pregnancies.
      Reunionese diabetics develop severe complications, in particular cardiovascular (strokes,
      myocardial infarction).

      This results in 3 times higher mortality linked to diabetes on Reunion Island, in particular
      among those under 65 years of age. Despite all the screening and prevention programs put in
      place, the weight of diabetic disease continues to increase in our island, and this is more
      accelerated than in the other French departments with 4,300 new cases of diabetes / year, 95%
      of which type 2 diabetics (T2D). The presentation of type 2 diabetic patients in Reunion
      island also differs from the Metropolis with subjects more often female (56%), thinner and
      younger at the discovery of diabetes. These data highlight the need to better understand the
      factors underlying the diabetes "epidemic" in Reunion island.

      The rise in blood sugar until the onset of diabetes is a continuous phenomenon reflecting the
      progressive suffering of the organs used to maintain carbohydrate homeostasis. Thus, we talk
      about fasting hyperglycemia when the fasting blood sugar is between 1.10 and 1.25 g / L
      (6.1-6.9 mmol / l) and glucose intolerance when the blood sugar 2 hours after taking 75 g of
      glucose is between 1.40 and 1.99 g / L (7.8-11.0 mmol / l). Subjects with fasting
      hyperglycemia or glucose intolerance constitute the target population at very high risk of
      developing diabetes (up to 70% of these subjects). They have an increased risk of developing
      diabetes at 1 year multiplied by 5 to 10 compared to normoglycemic subjects, hence the name
      "prediabetic subjects". This great variability in the risk of developing diabetes highlights
      the presence of associated risk / protective factors which it is important to find in order
      to adapt the monitoring and management. It is important in Reunion island, in view of the
      specificities presented by our population, to understand the pre-diabetes / diabetes
      transition and the risk and protective factors.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: The impact of the "Say No to Diabetes" intervention on the incidence of type 2 diabetes
time frame: 2 years
description: Diabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)
measure: Numer of patients with diagnosic of type 2 diabetes in subjects identified as pre-diabetic
time frame: 2 years
description: Prediabetes : fasting blood sugar is between 1.10 and 1.25 g / l (6.1 and 6.9 mmol / l) or a blood sugar level is between 1.40 and 1.99 g / l (7.8 and 11 0.0 mmol / l) 2 hours after taking 75g of glucose (HGPO test) Diabetes : fasting blood glucose ≥ 1.26 g / l (7 mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO ≥2 g / l (11.1 mmol / l)
measure: Number of patients return to normal blood sugar
time frame: 2 years
description: Normal blood sugar : fasting blood glucose <1.10 g / l (6.1mmol / l), or blood sugar 2 hours after taking 75 g of glucose during HGPO <1.40g / l (7.8 mmol / l).
measure: HbA1c assay for the diagnosis of glucose intolerance and prediabetes compared to HGPO
time frame: 2 years
description: HbA1c assay
arm group label: prevention program for prediabetes "Say No to Diabetes"
arm group type: Experimental
arm group label: No prevention program
arm group type: No Intervention
intervention type: Other
intervention name: prevention program for prediabetes "Say No to Diabetes"
description: 10 therapeutic education sessions
arm group label: prevention program for prediabetes "Say No to Diabetes"
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Samir MEDJANE
phone: 0262359750
phone ext: +262
email: samir.medjane@chu-reunion.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Prediabetic State
sharing ipd: No