<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/NCT01719029</url>
  </required_header>
  <id_info>
    <org_study_id>07-0283</org_study_id>
    <nct_id>NCT01719029</nct_id>
  </id_info>
  <brief_title>Role of Macronutrient Diet Composition and Infant Metabolic Outcomes in Gestational Diabetes</brief_title>
  <official_title>Role of Macronutrient Diet Composition on Maternal and Infant Metabolic Outcomes in Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A better understanding of the optimal diet for women with gestational diabetes is fundamental&#xD;
      to the management of this rapidly growing problem in pregnancy. Careful comparison studies of&#xD;
      the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate&#xD;
      but lower in fat is critical in order to determine which diet results in a more favorable&#xD;
      maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect&#xD;
      optimal fetal growth and may influence the future health of the offspring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the doubling in the prevalence of gestational diabetes mellitus (GDM) over the last&#xD;
      10 years, dietary management guidelines remain ambiguous due to the paucity of randomized&#xD;
      controlled trials. New diagnostic criteria recently developed for the diagnosis of GDM are&#xD;
      expected to increase the prevalence to 10-15% of all pregnant women. There is growing&#xD;
      recognition that GDM has long-term implications on maternal risk for diabetes and that the&#xD;
      intrauterine GDM environment is an independent risk factor for childhood obesity and impaired&#xD;
      glucose tolerance. Yet, how diet can be used to modify fetal fuel and attenuate this risk&#xD;
      remains unknown in humans. Fundamental to the management of GDM is dietary intervention, yet&#xD;
      the historic practice of advising a low-carbohydrate (CHO), higher-fat diet has not been&#xD;
      sufficiently tested. Both animal and non-human primate data support a fetal programming&#xD;
      influence that maternal high-fat diets may promote insulin resistance, glucose intolerance,&#xD;
      and hepatic steatosis in the offspring. Recent human data suggest that high maternal&#xD;
      triglycerides (TG) and free fatty acids (FFA), variables sensitive to dietary manipulation,&#xD;
      are independent risk factors for fetal macrosomia and adiposity. As a result, consensus&#xD;
      groups have abandoned any specific diet recommendations for women with GDM. Despite the&#xD;
      pivotal role of diet therapy in the treatment of GDM, no randomized trials have directly&#xD;
      compared glycemic and lipoprotein profiles of the conventional higher-fat diet with any other&#xD;
      diet. To address this critical need, the aims of this randomized cross-over trial are to&#xD;
      study the effects of a high complex carbohydrate/low-fat diet (HC/LF; 60% CHO, 25% fat, 15%&#xD;
      protein) compared to the usual care, low-CHO/higher fat diet (LC/HF; 40% CHO, 45% fat, and&#xD;
      15% protein) in GDM women on: 1) 72-hour glycemic profiles using a continuous glucose&#xD;
      monitoring system within subjects; 2) postprandial lipemia by measuring serial plasma TG and&#xD;
      FFA over a 5-hour, post-breakfast meal period within subjects; and 3) maternal lipoproteins,&#xD;
      inflammatory profiles, and in-vitro adipose tissue lipolysis after 6-8 weeks of diet therapy&#xD;
      between subjects. We will also measure neonatal adiposity by air displacement plethysmography&#xD;
      and newborn markers of lipid peroxidation, inflammation, and dietary fat intake in the babies&#xD;
      born to mothers with GDM. This pilot study will directly test which GDM diet is most&#xD;
      effective in limiting maternal hyperglycemia and hyperlipidemia in a randomized controlled&#xD;
      fashion, potentially optimizing fetal substrate availability and fetal growth. Our goal is to&#xD;
      determine which diet intervention might favorably impact a cycle that could otherwise&#xD;
      perpetuate future diabetes, obesity, and CVD in both mother and offspring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2007</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose area-under-the-curve</measure>
    <time_frame>During 3 days of each diet treatment</time_frame>
    <description>The average glucose area-under-the-curve over 3 days, calculated using 24-hour continuous glucose monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infant Adiposity</measure>
    <time_frame>2 weeks after birth</time_frame>
    <description>Infant adiposity measured using Pea Pod</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Conventional Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low carbohydrate/higher fat diet: 40% carbohydrate, 45% fat, 15% protein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complex Carbohydrate Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High complex carbohydrate/lower fat diet: 60% complex carbohydrate, 25% fat, 15% protein</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Carbohydrate/Higher Fat Diet</intervention_name>
    <arm_group_label>Complex Carbohydrate Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Carbohydrate/Low fat diet</intervention_name>
    <arm_group_label>Conventional Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Inclusion Criteria. Potential participants will be ≥ 0-36 years old,&#xD;
        which includes the offspring of the pregnant mothers with GDM. Pregnant women will be&#xD;
        between the ages of 18-40 years and will have a BMI of 26 - 35 kg/m2 at the time of&#xD;
        diagnosis, a singleton pregnancy, and will not be taking medication for their GDM on&#xD;
        entrance to the study. Subjects will have been diagnosed with GDM according to the criteria&#xD;
        established by the ADA and the ACOG (19;35;53), specifically, they will meet the following&#xD;
        criteria:&#xD;
&#xD;
          -  A 50-gram Glucola in which the one hour reading is &gt;200 mg/dL and the FBG is &gt;95 mg/dL&#xD;
&#xD;
          -  Two abnormal values on a 100-gram 3 hour glucose tolerance test based on the Coustan&#xD;
             and Carpenter criteria as adopted by the ADA and Fourth International Workshop on&#xD;
             Gestational Diabetes (76;77):&#xD;
&#xD;
               -  Fasting &gt; or = to 95 mg/dL but &lt;126 mg/dL&#xD;
&#xD;
               -  1 hr &gt;/= 180 mg/dL&#xD;
&#xD;
               -  2 hr &gt;/= 155 mg/dL&#xD;
&#xD;
               -  3 hr &gt;/=140 mg/dL&#xD;
&#xD;
        Exclusion Criteria:Those women with overt diabetes and those suspected of having&#xD;
        preexisting diabetes by any of the following criteria will be excluded, including:&#xD;
&#xD;
          -  Fasting glucose &gt;110 mg/dL, due to the high likelihood of rapidly failing diet and&#xD;
             requiring medical treatment (35).&#xD;
&#xD;
          -  Random glucose &gt; 200 mg/dL&#xD;
&#xD;
          -  Glycosylated hemoglobin A1C &gt; 6.5&#xD;
&#xD;
          -  Non-English speaking patient&#xD;
&#xD;
          -  Fasting TG &gt; 400 mg/dL&#xD;
&#xD;
        Women who smoke will be excluded since this is the leading cause of low birth weight. In&#xD;
        addition, women with other risk factors for placental insufficiency, including hypertension&#xD;
        requiring beta-blocker treatment, renal disease, thrombophilias, preeclampsia, steroid use,&#xD;
        history of pancreatitis or infectious disease such as hepatitis, or intrauterine growth&#xD;
        restriction will be excluded.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Colorado, Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>June 8, 2015</last_update_submitted>
  <last_update_submitted_qc>June 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>continuous glucose monitoring</keyword>
  <keyword>gestational diabetes</keyword>
  <keyword>diet therapy</keyword>
  <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/NCT01719029
org study id: 07-0283
nct id: NCT01719029
lead sponsor: 
collaborator: 
has dmc: No
A better understanding of the optimal diet for women with gestational diabetes is fundamental
      to the management of this rapidly growing problem in pregnancy. Careful comparison studies of
      the current low- carbohydrate, higher-fat diet versus a diet higher in complex carbohydrate
      but lower in fat is critical in order to determine which diet results in a more favorable
      maternal 24-hour glucose, lipid, and inflammatory profile, all of which directly effect
      optimal fetal growth and may influence the future health of the offspring.
Despite the doubling in the prevalence of gestational diabetes mellitus (GDM) over the last
      10 years, dietary management guidelines remain ambiguous due to the paucity of randomized
      controlled trials. New diagnostic criteria recently developed for the diagnosis of GDM are
      expected to increase the prevalence to 10-15% of all pregnant women. There is growing
      recognition that GDM has long-term implications on maternal risk for diabetes and that the
      intrauterine GDM environment is an independent risk factor for childhood obesity and impaired
      glucose tolerance. Yet, how diet can be used to modify fetal fuel and attenuate this risk
      remains unknown in humans. Fundamental to the management of GDM is dietary intervention, yet
      the historic practice of advising a low-carbohydrate (CHO), higher-fat diet has not been
      sufficiently tested. Both animal and non-human primate data support a fetal programming
      influence that maternal high-fat diets may promote insulin resistance, glucose intolerance,
      and hepatic steatosis in the offspring. Recent human data suggest that high maternal
      triglycerides (TG) and free fatty acids (FFA), variables sensitive to dietary manipulation,
      are independent risk factors for fetal macrosomia and adiposity. As a result, consensus
      groups have abandoned any specific diet recommendations for women with GDM. Despite the
      pivotal role of diet therapy in the treatment of GDM, no randomized trials have directly
      compared glycemic and lipoprotein profiles of the conventional higher-fat diet with any other
      diet. To address this critical need, the aims of this randomized cross-over trial are to
      study the effects of a high complex carbohydrate/low-fat diet (HC/LF; 60% CHO, 25% fat, 15%
      protein) compared to the usual care, low-CHO/higher fat diet (LC/HF; 40% CHO, 45% fat, and
      15% protein) in GDM women on: 1) 72-hour glycemic profiles using a continuous glucose
      monitoring system within subjects; 2) postprandial lipemia by measuring serial plasma TG and
      FFA over a 5-hour, post-breakfast meal period within subjects; and 3) maternal lipoproteins,
      inflammatory profiles, and in-vitro adipose tissue lipolysis after 6-8 weeks of diet therapy
      between subjects. We will also measure neonatal adiposity by air displacement plethysmography
      and newborn markers of lipid peroxidation, inflammation, and dietary fat intake in the babies
      born to mothers with GDM. This pilot study will directly test which GDM diet is most
      effective in limiting maternal hyperglycemia and hyperlipidemia in a randomized controlled
      fashion, potentially optimizing fetal substrate availability and fetal growth. Our goal is to
      determine which diet intervention might favorably impact a cycle that could otherwise
      perpetuate future diabetes, obesity, and CVD in both mother and offspring.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glucose area-under-the-curve
time frame: During 3 days of each diet treatment
description: The average glucose area-under-the-curve over 3 days, calculated using 24-hour continuous glucose monitoring
measure: Infant Adiposity
time frame: 2 weeks after birth
description: Infant adiposity measured using Pea Pod
arm group label: Conventional Diet
arm group type: Experimental
description: Low carbohydrate/higher fat diet: 40% carbohydrate, 45% fat, 15% protein
arm group label: Complex Carbohydrate Diet
arm group type: Experimental
description: High complex carbohydrate/lower fat diet: 60% complex carbohydrate, 25% fat, 15% protein
intervention type: Other
intervention name: Low-Carbohydrate/Higher Fat Diet
arm group label: Complex Carbohydrate Diet
intervention type: Other
intervention name: High Carbohydrate/Low fat diet
arm group label: Conventional Diet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus