<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/NCT02233283</url>
  </required_header>
  <id_info>
    <org_study_id>43/13</org_study_id>
    <secondary_id>320030_141065</secondary_id>
    <nct_id>NCT02233283</nct_id>
  </id_info>
  <brief_title>Effect of Modifications of Nutritional Intake Upon Reproductive Hormones in Normal Women</brief_title>
  <acronym>Polynut</acronym>
  <official_title>Effect of Metabolic Variations Upon the Activity of the Neuroendocrine Reproductive Axis in Normal Female Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Vaudois</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Undernutrition has a known and well recognized negative impact on reproductive hormones, and&#xD;
      ultimately fertility. In contrast, much less is known regarding the potential effects of&#xD;
      overnutrition on the same hormones. Epidemiological data suggest that overnutrition might&#xD;
      have a deleterious impact as well on the fertile potential of affected women, but very little&#xD;
      is known about the mechanisms implicated. Such knowledge may be of importance, given the&#xD;
      increasing prevalence of overweight and obesity worldwide.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, the investigators will perform a very detailed study of the minute to&#xD;
      minute regulation of hormones of the neuroendocrine reproductive axis in normal young female&#xD;
      volunteers. These studies will initially be performed at base line during isocaloric diet,&#xD;
      where the stimulation of LH secretion by exogenous insulin will be tested during&#xD;
      hyperinsulinemic eugylcemic clamp studies.&#xD;
&#xD;
      The same studies will then be repeated after a period of one month of controlled hypercaloric&#xD;
      diet, where volunteers will receive an excess of approximately 30% KCal compared to their&#xD;
      calculated daily energy expenditure. it is anticipated that such hypercaloric nutrition will&#xD;
      induce a significant decrease in normal insulin sensitivity of these volunteers. Thus, the&#xD;
      effect of changing whole body insulin sensitivity on the fine regulation of neuroendocrine&#xD;
      reproductive hormones will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Luteinizing hormone secretion</measure>
    <time_frame>Every ten minutes for 10 hours</time_frame>
    <description>The pulsatility of LH will be assessed by measuring LH levels in blood sample obtained every ten minutes over the entire study period (12 hours).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>10 hours</time_frame>
    <description>Insulin sensitivity will be defined as the rate of glucose infusion required to maintain euglycemia during the hyperinsulinemic clamp</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Female Reproductive System Disorder</condition>
  <arm_group>
    <arm_group_label>Hypercaloric diet and basal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypercaloric diet and clamp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isocaloric diet and basal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isocaloric diet and clamp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clamp</intervention_name>
    <description>Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.</description>
    <arm_group_label>Hypercaloric diet and clamp</arm_group_label>
    <arm_group_label>Isocaloric diet and clamp</arm_group_label>
    <other_name>Hyperinsulinemic and euglycemic clamp study</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypercaloric diet</intervention_name>
    <description>Hypercaloric diet will be conducted during one month, and designed to provide 30% excess in calories compared to daily requirements. It will consist in a high fat, high carbohydrates diet.</description>
    <arm_group_label>Hypercaloric diet and basal</arm_group_label>
    <arm_group_label>Hypercaloric diet and clamp</arm_group_label>
    <other_name>Overfeeding</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Basal</intervention_name>
    <description>Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)</description>
    <arm_group_label>Hypercaloric diet and basal</arm_group_label>
    <arm_group_label>Isocaloric diet and basal</arm_group_label>
    <other_name>Fasting</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isocaloric diet</intervention_name>
    <description>Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs</description>
    <arm_group_label>Isocaloric diet and basal</arm_group_label>
    <arm_group_label>Isocaloric diet and clamp</arm_group_label>
    <other_name>Controlled diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        normally cycling young (between 18 and 30 yo) female, with a BMI between 20 and 25 kg/m2.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of endocrine dysfunction (any kind)&#xD;
&#xD;
          -  Hormonal contraception&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Food allergy (any kind)&#xD;
&#xD;
          -  Intense physical activity (&gt;4 hrs/week)&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francois P Pralong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Center, University Hospital</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>August 20, 2015</last_update_submitted>
  <last_update_submitted_qc>August 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Vaudois</investigator_affiliation>
    <investigator_full_name>Francois Pralong</investigator_full_name>
    <investigator_title>Full professor and Head, Service of Endocrinology, Diabetology and Metabolism</investigator_title>
  </responsible_party>
  <keyword>LH pulsatility</keyword>
  <keyword>Insulin sensitivity</keyword>
  <keyword>Metabolism</keyword>
  <keyword>hypercaloric feeding</keyword>
  <!-- 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/NCT02233283
org study id: 43/13
secondary id: 320030_141065
nct id: NCT02233283
lead sponsor: 
has dmc: No
Undernutrition has a known and well recognized negative impact on reproductive hormones, and
      ultimately fertility. In contrast, much less is known regarding the potential effects of
      overnutrition on the same hormones. Epidemiological data suggest that overnutrition might
      have a deleterious impact as well on the fertile potential of affected women, but very little
      is known about the mechanisms implicated. Such knowledge may be of importance, given the
      increasing prevalence of overweight and obesity worldwide.
In the present study, the investigators will perform a very detailed study of the minute to
      minute regulation of hormones of the neuroendocrine reproductive axis in normal young female
      volunteers. These studies will initially be performed at base line during isocaloric diet,
      where the stimulation of LH secretion by exogenous insulin will be tested during
      hyperinsulinemic eugylcemic clamp studies.

      The same studies will then be repeated after a period of one month of controlled hypercaloric
      diet, where volunteers will receive an excess of approximately 30% KCal compared to their
      calculated daily energy expenditure. it is anticipated that such hypercaloric nutrition will
      induce a significant decrease in normal insulin sensitivity of these volunteers. Thus, the
      effect of changing whole body insulin sensitivity on the fine regulation of neuroendocrine
      reproductive hormones will be evaluated.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Luteinizing hormone secretion
time frame: Every ten minutes for 10 hours
description: The pulsatility of LH will be assessed by measuring LH levels in blood sample obtained every ten minutes over the entire study period (12 hours).
measure: Insulin sensitivity
time frame: 10 hours
description: Insulin sensitivity will be defined as the rate of glucose infusion required to maintain euglycemia during the hyperinsulinemic clamp
arm group label: Hypercaloric diet and basal
arm group type: Active Comparator
description: Volunteers fed a hypercaloric diet for one month will be submitted to a fasting period of ten hours duration
arm group label: Hypercaloric diet and clamp
arm group type: Experimental
description: Volunteers fed a hypercaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
arm group label: Isocaloric diet and basal
arm group type: Active Comparator
description: Volunteers fed a isocaloric diet for one month will be submitted to a fasting period of ten hours duration
arm group label: Isocaloric diet and clamp
arm group type: Experimental
description: Volunteers fed a isocaloric diet for one month will be submitted to a hyperinsulinemic and euglycemic clamp of ten hours duration
intervention type: Other
intervention name: Clamp
description: Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
arm group label: Hypercaloric diet and clamp
arm group label: Isocaloric diet and clamp
other name: Hyperinsulinemic and euglycemic clamp study
intervention type: Other
intervention name: Hypercaloric diet
description: Hypercaloric diet will be conducted during one month, and designed to provide 30% excess in calories compared to daily requirements. It will consist in a high fat, high carbohydrates diet.
arm group label: Hypercaloric diet and basal
arm group label: Hypercaloric diet and clamp
other name: Overfeeding
intervention type: Other
intervention name: Basal
description: Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
arm group label: Hypercaloric diet and basal
arm group label: Isocaloric diet and basal
other name: Fasting
intervention type: Other
intervention name: Isocaloric diet
description: Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs
arm group label: Isocaloric diet and basal
arm group label: Isocaloric diet and clamp
other name: Controlled diet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Francois P Pralong, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Vaudois
investigator full name: Francois Pralong
investigator title: Full professor and Head, Service of Endocrinology, Diabetology and Metabolism