<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/NCT01678469</url>
  </required_header>
  <id_info>
    <org_study_id>2011-A001138-33</org_study_id>
    <nct_id>NCT01678469</nct_id>
  </id_info>
  <brief_title>Lipophilic Micronutrients, Adipokines and Gestational Diabetes Mellitus</brief_title>
  <acronym>2011-23</acronym>
  <official_title>Lipophilic Micronutrients, Adipokines and Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <brief_summary>
    <textblock>
      Background Gestational diabetes mellitus (GDM) is defined as a defect of glucose tolerance&#xD;
      with its onset or its first recognition during pregnancy and that usually disappears, at&#xD;
      least temporarily, after delivery. Its prevalence generally ranges between 3 and 6%, but may&#xD;
      reach 12 to 15% in high-risk populations or specific ethnic groups. GDM increases the risk of&#xD;
      potentially severe maternal, fetal and neonatal complications (gestational hypertension,&#xD;
      pre-eclampsia, caesarean delivery; macrosomia; shoulder dystocia). These risks are linearly&#xD;
      correlated with the level of maternal hyperglycaemia. GDM is due to a failure of pancreatic&#xD;
      beta cells to sustain compensatory insulin secretion for insulin resistance that is&#xD;
      physiological in pregnancy but can be much more pronounced in some women, especially in case&#xD;
      of overweight or obesity. Maternal obesity is a major risk factor of GDM. Yet, micronutrient&#xD;
      deficiencies are frequently reported in obese patients. Some nutritional deficiencies,&#xD;
      concerning particularly some lipophilic micronutrients (vitamin A, vitamin D, vitamin E,&#xD;
      carotenoids) may be associated with diseases linked to insulin resistance. Numerous studies&#xD;
      show an inverse relationship between plasma concentrations and/or dietary intake of these&#xD;
      micronutrients and incidence of type 2 diabetes. Vitamin D deficiency could be involved in&#xD;
      the pathogenesis of type 2 diabetes through an alteration of insulin secretion and&#xD;
      sensitivity. Deficiencies in vitamin A, vitamin E or carotenoids (in particular lycopene and&#xD;
      beta carotene) increase oxidative stress and pro-inflammatory status, and could thus be&#xD;
      implied in the physiopathology of insulin resistance and glucose intolerance.&#xD;
&#xD;
      Some case-control studies find an inverse correlation between the plasma concentrations of&#xD;
      vitamin D during pregnancy and the incidence of GDM, independently of age, ethnic origin and&#xD;
      of body mass index. Data are scarce for vitamin A and vitamin E, and are lacking for&#xD;
      carotenoids. Besides, the few available studies are mainly descriptive ones, without clear&#xD;
      explanations on underlying mechanisms. The favourable effects of these micronutrients on&#xD;
      insulin sensitivity could be partially mediated by adipokines and/or pro-inflammatory&#xD;
      cytokines secreted at the level of the adipose tissue. Numerous studies showed that women&#xD;
      developing GDM during their pregnancy presented with a significant decrease in the&#xD;
      circulating rates of adiponectin, (that is an adipokine with anti-inflammatory and&#xD;
      insulin-sensitizing properties) and a significant increase in the secretion of the&#xD;
      pro-inflammatory cytokines implied in the physiopathology of insulin resistance. In our&#xD;
      laboratory (INRA unit 1260), we showed in experimental works conducted in vitro in human&#xD;
      adipocytes and in vivo in mice that vitamin E could induce the transcription and the&#xD;
      secretion of adiponectin; we also showed that vitamin D or lycopene could modulate the&#xD;
      inflammatory reaction in the adipose tissue, which is involved in the physiopathology of&#xD;
      insulin resistance.&#xD;
&#xD;
      Aims and methods We hypothesise that, in pregnant women, there is a link between plasma&#xD;
      concentrations and dietary intakes of lipophilic micronutrients (mainly vitamins A, D, E and&#xD;
      carotenoids), secretion of adipokines and pro-inflammatory cytokines, and risk of developing&#xD;
      a GDM; we also hypothesise that this relationship is independent of age, body mass index,&#xD;
      ethnic origin and other main risk factors of GDM. To test this hypothesis, we aim to lead a&#xD;
      transversal monocentric study, within a population of 500 pregnant women submitted to a&#xD;
      systematic screening of GDM by an oral glucose tolerance test (OGTT) in the Hôpital Nord of&#xD;
      Marseilles.&#xD;
&#xD;
      The main criterion of evaluation of the link between lipophilic micronutrients and GDM will&#xD;
      be a nutritional score calculated as follows: for each micronutrient (vitamin A, D, E,&#xD;
      lycopene, beta carotene, alpha carotene, lutein), we will attribute 0 point if the patient is&#xD;
      situated in the lowest quartile, 1 or 2 points in the following quartiles, and 3 points in&#xD;
      the highest quartile. At the end, each patient will thus have a score between 0 and 21&#xD;
      reflecting the global status of these micronutrients.&#xD;
&#xD;
      The main secondary objectives will be to define the relationships between the plasma&#xD;
      concentrations and dietary intakes of these micronutrients and 1/the value of glycemia and&#xD;
      insulinemia during OGTT 2/the degree of insulin sensitivity estimated by the measure of HOMA&#xD;
      index, 3/the circulating rates of some adipokines (mainly adiponectin, leptin, chemerin) and&#xD;
      pro-inflammatory cytokines (TNF alpha, IL-1, IL-6), and 4/the children's birth weight.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2011</start_date>
  <completion_date type="Actual">October 27, 2022</completion_date>
  <primary_completion_date type="Actual">January 21, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>link between plasma concentrations and dietary intakes of lipophilic micronutrients and risk of developing a Gestational diabetes mellitus</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">348</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>blood sample</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample</intervention_name>
    <arm_group_label>blood sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant woman screen for Gestational diabetes mellitus (GDM)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant woman with intercurate disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assitance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>November 9, 2022</last_update_submitted>
  <last_update_submitted_qc>November 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</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, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</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/NCT01678469
org study id: 2011-A001138-33
nct id: NCT01678469
lead sponsor: 
Background Gestational diabetes mellitus (GDM) is defined as a defect of glucose tolerance
      with its onset or its first recognition during pregnancy and that usually disappears, at
      least temporarily, after delivery. Its prevalence generally ranges between 3 and 6%, but may
      reach 12 to 15% in high-risk populations or specific ethnic groups. GDM increases the risk of
      potentially severe maternal, fetal and neonatal complications (gestational hypertension,
      pre-eclampsia, caesarean delivery; macrosomia; shoulder dystocia). These risks are linearly
      correlated with the level of maternal hyperglycaemia. GDM is due to a failure of pancreatic
      beta cells to sustain compensatory insulin secretion for insulin resistance that is
      physiological in pregnancy but can be much more pronounced in some women, especially in case
      of overweight or obesity. Maternal obesity is a major risk factor of GDM. Yet, micronutrient
      deficiencies are frequently reported in obese patients. Some nutritional deficiencies,
      concerning particularly some lipophilic micronutrients (vitamin A, vitamin D, vitamin E,
      carotenoids) may be associated with diseases linked to insulin resistance. Numerous studies
      show an inverse relationship between plasma concentrations and/or dietary intake of these
      micronutrients and incidence of type 2 diabetes. Vitamin D deficiency could be involved in
      the pathogenesis of type 2 diabetes through an alteration of insulin secretion and
      sensitivity. Deficiencies in vitamin A, vitamin E or carotenoids (in particular lycopene and
      beta carotene) increase oxidative stress and pro-inflammatory status, and could thus be
      implied in the physiopathology of insulin resistance and glucose intolerance.

      Some case-control studies find an inverse correlation between the plasma concentrations of
      vitamin D during pregnancy and the incidence of GDM, independently of age, ethnic origin and
      of body mass index. Data are scarce for vitamin A and vitamin E, and are lacking for
      carotenoids. Besides, the few available studies are mainly descriptive ones, without clear
      explanations on underlying mechanisms. The favourable effects of these micronutrients on
      insulin sensitivity could be partially mediated by adipokines and/or pro-inflammatory
      cytokines secreted at the level of the adipose tissue. Numerous studies showed that women
      developing GDM during their pregnancy presented with a significant decrease in the
      circulating rates of adiponectin, (that is an adipokine with anti-inflammatory and
      insulin-sensitizing properties) and a significant increase in the secretion of the
      pro-inflammatory cytokines implied in the physiopathology of insulin resistance. In our
      laboratory (INRA unit 1260), we showed in experimental works conducted in vitro in human
      adipocytes and in vivo in mice that vitamin E could induce the transcription and the
      secretion of adiponectin; we also showed that vitamin D or lycopene could modulate the
      inflammatory reaction in the adipose tissue, which is involved in the physiopathology of
      insulin resistance.

      Aims and methods We hypothesise that, in pregnant women, there is a link between plasma
      concentrations and dietary intakes of lipophilic micronutrients (mainly vitamins A, D, E and
      carotenoids), secretion of adipokines and pro-inflammatory cytokines, and risk of developing
      a GDM; we also hypothesise that this relationship is independent of age, body mass index,
      ethnic origin and other main risk factors of GDM. To test this hypothesis, we aim to lead a
      transversal monocentric study, within a population of 500 pregnant women submitted to a
      systematic screening of GDM by an oral glucose tolerance test (OGTT) in the Hôpital Nord of
      Marseilles.

      The main criterion of evaluation of the link between lipophilic micronutrients and GDM will
      be a nutritional score calculated as follows: for each micronutrient (vitamin A, D, E,
      lycopene, beta carotene, alpha carotene, lutein), we will attribute 0 point if the patient is
      situated in the lowest quartile, 1 or 2 points in the following quartiles, and 3 points in
      the highest quartile. At the end, each patient will thus have a score between 0 and 21
      reflecting the global status of these micronutrients.

      The main secondary objectives will be to define the relationships between the plasma
      concentrations and dietary intakes of these micronutrients and 1/the value of glycemia and
      insulinemia during OGTT 2/the degree of insulin sensitivity estimated by the measure of HOMA
      index, 3/the circulating rates of some adipokines (mainly adiponectin, leptin, chemerin) and
      pro-inflammatory cytokines (TNF alpha, IL-1, IL-6), and 4/the children's birth weight.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: link between plasma concentrations and dietary intakes of lipophilic micronutrients and risk of developing a Gestational diabetes mellitus
time frame: 3 years
arm group label: blood sample
arm group type: Other
intervention type: Other
intervention name: blood sample
arm group label: blood sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus