<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/NCT01711476</url>
  </required_header>
  <id_info>
    <org_study_id>HCCCBI 018-2008-104</org_study_id>
    <nct_id>NCT01711476</nct_id>
  </id_info>
  <brief_title>Meal Timing on Glucose and Hyperandrogenism in PCOS Women</brief_title>
  <acronym>MealTimePCOS</acronym>
  <official_title>Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas Caracas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas Caracas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the effects of two isocaloric maintenance diets&#xD;
      with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome&#xD;
      P450c17 alpha activity in lean PCOS women.&#xD;
&#xD;
      The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist&#xD;
      in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high&#xD;
      calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to&#xD;
      OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS&#xD;
      women. These women are insulin resistant and have compensatory hyperinsulinemia that&#xD;
      stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian androgen&#xD;
      concentrations.&#xD;
&#xD;
      In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting&#xD;
      in improvement of clinical symptoms.&#xD;
&#xD;
      Since lean PCOS women do not have the option of weight loss, it is important to know if&#xD;
      composition and meal timing distribution may influence glucose metabolism and&#xD;
      hyperandrogenism and cytochrome P450c17 alpha activity. We hypothesized that a timing pattern&#xD;
      of increased nutrient intake of protein and carbohydrates in the morning, with decreased&#xD;
      caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women&#xD;
      with PCOS&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Androgens and 17 alpha hydroxyprogesterone serum levels</measure>
    <time_frame>90 days</time_frame>
    <description>The androgens (testosterone, free testosterone, DHEA-S, androstenedione)and 17 alpha hydroxyprogesterone will be measured at baseline and again will be measured at the end of the trial by day 90. In both groups or Arms one on breakfast diet and the other on dinner diet.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose and Insulin Response to OGTT</measure>
    <time_frame>90</time_frame>
    <description>Glucose and Insulin Response to OGTT will be measured at baseline and again will be repeated after 90 days of the trial for comparison One group will be assigned to breakfast diet and the other group to dinner diet</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ovulatory frequency</measure>
    <time_frame>90 days</time_frame>
    <description>From baseline (day O) to the end of the study (day 90) progesterone will be quantified weekly to assess the ovulation in both of the group (The ovulation in the breakfast diet group will be compared to that of the dinner diet group)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Polycystic Ovary Syndrome (PCOS) Women</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling ARM 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 1 Breakfast Diet The arm 1 will be assigned to eat High calorie breakfast (800kcal) and reduced dinner (200 kcal) During 90 days from baseline to the end of the trial (day 90)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle counseling ARM 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lean PCOS women in the Arm 2 will be assigned to do a dinner diet from day 0 to day 90 of the trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2</intervention_name>
    <description>In this Arm 2 group the PCOS will be assigned to dinner diet and we will compare the androgen levels Day 0 to androgen after DAY 90 of this diet also we will compare Glucose and Insulin response to OGTT Day 0 and Day 90, and ovulatory frequency along alll the 90 days of the Dinner diet</description>
    <arm_group_label>Lifestyle counseling ARM 2</arm_group_label>
    <other_name>The lean PCOS patients assigned to dinner diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active Comparator: Lifestyle counseling ARM 1</intervention_name>
    <description>In the Arm 1 we will measure androgen levels and insulin and glucose response to OGTT at baseline DAY 0 and after 90 days on the dinner diet (Day 90) for comparison Also we will evaluate by weekly progesterone the ovulatory events</description>
    <arm_group_label>Lifestyle counseling ARM 1</arm_group_label>
    <other_name>Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        lean women with Polycystic Ovary BMI below 25 kg/m2 Testosterone above 1.0 ng/ml 17 Oh&#xD;
        progesterone below 200 ng/ml US of Polycystic Ovaries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like hypothyroidism,&#xD;
        late onset adrenal hyperplasia Pregnancy Contraceptive or other hormonal treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniela Jakubowicz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clinicas Caracas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniela Jakubowicz, MD</last_name>
    <phone>582123355075</phone>
    <email>daniela.jak@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Daniela Jakubowicz</name>
      <address>
        <city>Caracas</city>
        <state>San Bernardino</state>
        <zip>410</zip>
        <country>Venezuela</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniela Jakubowicz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Venezuela</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>January 20, 2013</last_update_submitted>
  <last_update_submitted_qc>January 20, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas Caracas</investigator_affiliation>
    <investigator_full_name>Daniela Jakubowicz, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>Bdiet</keyword>
  <keyword>Ddiet</keyword>
  <keyword>OGTT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Hyperandrogenism</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Complement Factor H</mesh_term>
  </intervention_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/NCT01711476
org study id: HCCCBI 018-2008-104
nct id: NCT01711476
lead sponsor: 
has dmc: Yes
The objective of this study is to investigate the effects of two isocaloric maintenance diets
      with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome
      P450c17 alpha activity in lean PCOS women.

      The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist
      in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high
      calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to
      OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.
Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS
      women. These women are insulin resistant and have compensatory hyperinsulinemia that
      stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian androgen
      concentrations.

      In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting
      in improvement of clinical symptoms.

      Since lean PCOS women do not have the option of weight loss, it is important to know if
      composition and meal timing distribution may influence glucose metabolism and
      hyperandrogenism and cytochrome P450c17 alpha activity. We hypothesized that a timing pattern
      of increased nutrient intake of protein and carbohydrates in the morning, with decreased
      caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women
      with PCOS
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Androgens and 17 alpha hydroxyprogesterone serum levels
time frame: 90 days
description: The androgens (testosterone, free testosterone, DHEA-S, androstenedione)and 17 alpha hydroxyprogesterone will be measured at baseline and again will be measured at the end of the trial by day 90. In both groups or Arms one on breakfast diet and the other on dinner diet.
measure: Glucose and Insulin Response to OGTT
time frame: 90
description: Glucose and Insulin Response to OGTT will be measured at baseline and again will be repeated after 90 days of the trial for comparison One group will be assigned to breakfast diet and the other group to dinner diet
measure: Ovulatory frequency
time frame: 90 days
description: From baseline (day O) to the end of the study (day 90) progesterone will be quantified weekly to assess the ovulation in both of the group (The ovulation in the breakfast diet group will be compared to that of the dinner diet group)
arm group label: Lifestyle counseling ARM 1
arm group type: Active Comparator
description: Arm 1 Breakfast Diet The arm 1 will be assigned to eat High calorie breakfast (800kcal) and reduced dinner (200 kcal) During 90 days from baseline to the end of the trial (day 90)
arm group label: Lifestyle counseling ARM 2
arm group type: Placebo Comparator
description: Lean PCOS women in the Arm 2 will be assigned to do a dinner diet from day 0 to day 90 of the trial
intervention type: Behavioral
intervention name: Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2
description: In this Arm 2 group the PCOS will be assigned to dinner diet and we will compare the androgen levels Day 0 to androgen after DAY 90 of this diet also we will compare Glucose and Insulin response to OGTT Day 0 and Day 90, and ovulatory frequency along alll the 90 days of the Dinner diet
arm group label: Lifestyle counseling ARM 2
other name: The lean PCOS patients assigned to dinner diet
intervention type: Other
intervention name: Active Comparator: Lifestyle counseling ARM 1
description: In the Arm 1 we will measure androgen levels and insulin and glucose response to OGTT at baseline DAY 0 and after 90 days on the dinner diet (Day 90) for comparison Also we will evaluate by weekly progesterone the ovulatory events
arm group label: Lifestyle counseling ARM 1
other name: Lean PCOS women in ARM 1 will be assigned to Breakfast diet from Day 0 to day 90 of the study
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 50 Years
healthy volunteers: No
last name: Daniela Jakubowicz, MD
role: Principal Investigator
affiliation: Hospital de Clinicas Caracas
last name: Daniela Jakubowicz, MD
phone: 582123355075
email: daniela.jak@gmail.com
facility: 
status: Recruiting
investigator: 
country: Venezuela
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas Caracas
investigator full name: Daniela Jakubowicz, MD
investigator title: MD
mesh term: Polycystic Ovary Syndrome
mesh term: Hyperandrogenism
mesh term: Syndrome
mesh term: Complement Factor H