<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/NCT03028506</url>
  </required_header>
  <id_info>
    <org_study_id>25217</org_study_id>
    <nct_id>NCT03028506</nct_id>
  </id_info>
  <brief_title>Meal Composition and the Influence on Pre-prandial Blood Glucose Values</brief_title>
  <official_title>Meal Composition and Frequency in Type 1 Diabetic Women and the Influence on Pre-prandial Blood Glucose Values and Fetal Weight.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</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 purpose of the proposed study is to assess the distribution of carbohydrates and fat in&#xD;
      the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at&#xD;
      the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The&#xD;
      carbohydrate distribution and fat content of the meal will be compared to maternal glucose&#xD;
      control, preprandial glucose levels, and the percentile for weight of the infant at birth. In&#xD;
      addition, each meal and snack will be classified as low-moderate fat or high fat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a retrospective chart review. Data will be collected on all patients seen whose blood&#xD;
      sugar and food logs were at least 75% complete. By calculating carbohydrate amounts at meals&#xD;
      and snacks, as well as classifying meals and snacks as high fat, we will examine the&#xD;
      correlation to higher preprandial blood glucose values and large for gestational age infants.&#xD;
      Preprandial glucose levels will be reviewed, questioning whether the biggest contributor is&#xD;
      the composition of the previous meal or additional snacks between meals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>large for gestational age infants</measure>
    <time_frame>1 year</time_frame>
    <description>weight at birth</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Diabetes in Pregnancy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carbohydrate intake</intervention_name>
    <description>By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, the investigators will examine the correlation to higher preprandial blood glucose values and large for gestational age infants.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant, all ethnic groups&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female, age 16-45, all ethnic groups,&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Blood glucose logs at least 75% complete&#xD;
&#xD;
          -  Food intake records during weeks 29-32 that are at least 75% complete&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maternal medical conditions:&#xD;
&#xD;
               -  Renal disease&#xD;
&#xD;
               -  Restrictive lung disease&#xD;
&#xD;
               -  Cyanotic heart disease (severe heart disease where mother is blue)&#xD;
&#xD;
               -  Antiphospholipid antibody syndrome&#xD;
&#xD;
               -  Collagen-vascular disease (lupus)&#xD;
&#xD;
               -  Substance use and abuse (drugs)&#xD;
&#xD;
               -  Multiple gestation&#xD;
&#xD;
               -  Genetic disorders&#xD;
&#xD;
               -  Severe malnutrition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosemary Catanzaro, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Rosemary Catanzaro, RD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes, Gestational</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/NCT03028506
org study id: 25217
nct id: NCT03028506
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed study is to assess the distribution of carbohydrates and fat in
      the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at
      the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The
      carbohydrate distribution and fat content of the meal will be compared to maternal glucose
      control, preprandial glucose levels, and the percentile for weight of the infant at birth. In
      addition, each meal and snack will be classified as low-moderate fat or high fat.
This is a retrospective chart review. Data will be collected on all patients seen whose blood
      sugar and food logs were at least 75% complete. By calculating carbohydrate amounts at meals
      and snacks, as well as classifying meals and snacks as high fat, we will examine the
      correlation to higher preprandial blood glucose values and large for gestational age infants.
      Preprandial glucose levels will be reviewed, questioning whether the biggest contributor is
      the composition of the previous meal or additional snacks between meals.
observational model: Cohort
time perspective: Retrospective
measure: large for gestational age infants
time frame: 1 year
description: weight at birth
intervention type: Other
intervention name: Carbohydrate intake
description: By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, the investigators will examine the correlation to higher preprandial blood glucose values and large for gestational age infants.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 45 Years
healthy volunteers: No
last name: Rosemary Catanzaro, RD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Rosemary Catanzaro, RD
investigator title: Principal Investigator
mesh term: Pregnancy in Diabetics
mesh term: Diabetes, Gestational
sharing ipd: No