<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/NCT03029702</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16100499</org_study_id>
    <nct_id>NCT03029702</nct_id>
  </id_info>
  <brief_title>Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus</brief_title>
  <acronym>MATCh-GDM</acronym>
  <official_title>Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maisa N. Feghali, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over&#xD;
      400,000 pregnant women in the United States each year. Without adequate treatment, women with&#xD;
      GDM and their infants are at risk for substantial morbidity. Because of this, experts&#xD;
      recommend treatment focused on normalization of hyperglycemia to improve outcomes. However,&#xD;
      providers have limited capacity to predict which treatment will achieve glycemic goals. This&#xD;
      results in a choice based on provider and patient preference and a trial and error approach,&#xD;
      which can create delays in glycemic control within the short (8-10 weeks) window between&#xD;
      diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between&#xD;
      glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM&#xD;
      is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit&#xD;
      (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of&#xD;
      hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use&#xD;
      of an individualized treatment approach. The overall goal of this project is to investigate&#xD;
      an individualized treatment approach for GDM where treatment is based on each woman's GDM&#xD;
      mechanism. The study will employ the same treatment in both arms, but choice of treatment&#xD;
      will differ based on study arm (matched or unmatched to GDM mechanism).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 28, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Pilot randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Study team members assessing delivery outcomes will be masked to the participant's study assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of women who are eligible, screened, enroll and remain in the study</measure>
    <time_frame>Through study completion, an average of 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants who report suitability of the study procedures</measure>
    <time_frame>Through study completion, an average of 16 weeks</time_frame>
    <description>Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants with consistent GDM mechanism before and and after treatment initiation</measure>
    <time_frame>2 weeks after treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of women who remain on same treatment during study</measure>
    <time_frame>Through study completion, an average of 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal glucose control</measure>
    <time_frame>Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who deliver by primary cesarean</measure>
    <time_frame>Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who developed hypertensive diseases in pregnancy</measure>
    <time_frame>Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birthweight</measure>
    <time_frame>Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal lean body mass</measure>
    <time_frame>Within 72 hours of delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord blood glucose</measure>
    <time_frame>Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord blood c-peptide</measure>
    <time_frame>Delivery</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Diabetes, Gestational</condition>
  <condition>Pregnancy in Diabetes</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individualized Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin</intervention_name>
    <description>Insulin will be used for GDM treatment</description>
    <arm_group_label>Individualized Treatment</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glyburide</intervention_name>
    <description>Glyburide will be used for GDM treatment</description>
    <arm_group_label>Individualized Treatment</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Metformin will be used for GDM treatment</description>
    <arm_group_label>Individualized Treatment</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral&#xD;
             glucose tolerance test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fetal anomaly&#xD;
&#xD;
          -  Pregestational diabetes&#xD;
&#xD;
          -  GDM diagnosis without a 3-hour OGTT&#xD;
&#xD;
          -  Multifetal gestation&#xD;
&#xD;
          -  Treatment with non-inhaled steroids within 7 days&#xD;
&#xD;
          -  Allergy to glyburide, metformin or sulfa&#xD;
&#xD;
          -  History of severe pulmonary (pulmonary requirement for oxygen therapy or daily&#xD;
             treatment for restrictive of obstructive pulmonary disease)&#xD;
&#xD;
          -  Hepatic (LFT's greater than two times of upper normal range)&#xD;
&#xD;
          -  Renal (serum creatinine higher than 1.2 mg/dL) disease&#xD;
&#xD;
          -  History of heart failure or myocardial infarction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maisa N Feghali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maisa N Feghali, MD</last_name>
    <phone>4126414874</phone>
    <email>feghalim@upmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Magee Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maisa Feghali, MD</last_name>
      <phone>412-641-4874</phone>
      <email>feghalim@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Maisa Feghali, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 6, 2023</last_update_submitted>
  <last_update_submitted_qc>January 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Maisa N. Feghali, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Gestational diabetes</keyword>
  <keyword>Diabetes in pregnancy</keyword>
  <keyword>Insulin resistance</keyword>
  <keyword>Insulin secretion deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Glyburide</mesh_term>
  </intervention_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/NCT03029702
org study id: PRO16100499
nct id: NCT03029702
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over
      400,000 pregnant women in the United States each year. Without adequate treatment, women with
      GDM and their infants are at risk for substantial morbidity. Because of this, experts
      recommend treatment focused on normalization of hyperglycemia to improve outcomes. However,
      providers have limited capacity to predict which treatment will achieve glycemic goals. This
      results in a choice based on provider and patient preference and a trial and error approach,
      which can create delays in glycemic control within the short (8-10 weeks) window between
      diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between
      glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM
      is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit
      (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of
      hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use
      of an individualized treatment approach. The overall goal of this project is to investigate
      an individualized treatment approach for GDM where treatment is based on each woman's GDM
      mechanism. The study will employ the same treatment in both arms, but choice of treatment
      will differ based on study arm (matched or unmatched to GDM mechanism).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot randomized controlled study
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Study team members assessing delivery outcomes will be masked to the participant's study assignment
measure: Proportion of women who are eligible, screened, enroll and remain in the study
time frame: Through study completion, an average of 16 weeks
measure: Proportion of participants who report suitability of the study procedures
time frame: Through study completion, an average of 16 weeks
description: Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview
measure: Proportion of participants with consistent GDM mechanism before and and after treatment initiation
time frame: 2 weeks after treatment initiation
measure: Proportion of women who remain on same treatment during study
time frame: Through study completion, an average of 16 weeks
measure: Maternal glucose control
time frame: Delivery
measure: Proportion of participants who deliver by primary cesarean
time frame: Delivery
measure: Proportion of participants who developed hypertensive diseases in pregnancy
time frame: Delivery
measure: Birthweight
time frame: Delivery
measure: Neonatal lean body mass
time frame: Within 72 hours of delivery
measure: Cord blood glucose
time frame: Delivery
measure: Cord blood c-peptide
time frame: Delivery
arm group label: Usual Care
arm group type: Active Comparator
description: Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.
arm group label: Individualized Treatment
arm group type: Active Comparator
description: Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.
intervention type: Drug
intervention name: Insulin
description: Insulin will be used for GDM treatment
arm group label: Individualized Treatment
arm group label: Usual Care
intervention type: Drug
intervention name: Glyburide
description: Glyburide will be used for GDM treatment
arm group label: Individualized Treatment
arm group label: Usual Care
intervention type: Drug
intervention name: Metformin
description: Metformin will be used for GDM treatment
arm group label: Individualized Treatment
arm group label: Usual Care
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Maisa N Feghali, MD
role: Principal Investigator
affiliation: University of Pittsburgh
last name: Maisa N Feghali, MD
phone: 4126414874
email: feghalim@upmc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Maisa N. Feghali, MD
investigator title: Assistant Professor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
mesh term: Metformin
mesh term: Glyburide
sharing ipd: No