<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/NCT01693406</url>
  </required_header>
  <id_info>
    <org_study_id>12-0629</org_study_id>
    <nct_id>NCT01693406</nct_id>
  </id_info>
  <brief_title>Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers</brief_title>
  <acronym>MIG</acronym>
  <official_title>Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thrasher Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Diabetes Association</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>
      Childhood obesity is a critical global public health concern. Breastfeeding is the ideal&#xD;
      choice for infant nutrition. However, rapid and excess weight gain during infancy predicts&#xD;
      later, even among breastfed infants. This risk is higher if mothers are obese and/or&#xD;
      diabetic. Composition of bioactive components of breast milk may differ based between mothers&#xD;
      who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are&#xD;
      associated with overall increases in inflammation and oxidative stress, but how breast milk&#xD;
      composition is affected remains unknown. The investigators overarching goal is to determine&#xD;
      how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how&#xD;
      differences in composition may impact infant growth and fat development. The investigators&#xD;
      are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and&#xD;
      20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The&#xD;
      investigators will track infant weight and fat gain and monitor maternal glucose control. The&#xD;
      investigators will also collect breast milk samples over the first 4 months and measure&#xD;
      concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and&#xD;
      nutrient composition in milk. The investigators predict that concentrations of&#xD;
      growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and&#xD;
      markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast&#xD;
      milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers'&#xD;
      breast milk. The investigators expect these differences will be most pronounced in the first&#xD;
      2 weeks after birth. The investigators also predict that breast milk concentrations of these&#xD;
      biomarkers will be associated with infant fat gain. What the investigators find will help&#xD;
      understand how early infant nutrition and growth may affect that child's later risk of&#xD;
      obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">September 2020</completion_date>
  <primary_completion_date type="Actual">August 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in infant percent body fat from birth to 4 months</measure>
    <time_frame>Birth, 2 weeks, 1, 2, 3, and 4 months</time_frame>
    <description>Body composition is measured by skin folds and air displacement plethysmography (PeaPod)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Human Milk Hormone Composition</measure>
    <time_frame>2 weeks, 1, 2, 3, and 4 months</time_frame>
    <description>The investigators will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Human Milk cytokine content</measure>
    <time_frame>2 weeks, 1, 2, 3, and 4 months</time_frame>
    <description>The investigators will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Antioxidant capacity of human milk</measure>
    <time_frame>2 weeks, 1, 2, 3, and 4 months</time_frame>
    <description>The investigators will analyze: TBARS, 8-OH-dG, HNE, and F2-isoprostane concentrations and total antioxidant capacity in human milk samples collected at these time points.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Human Milk Nutrient Composition</measure>
    <time_frame>2 weeks, 1, 2, 3, and 4 months</time_frame>
    <description>The investigators will analyze: glucose, percent fat, protein and caloric content of human milk samples collected at these time points.</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Obesity</condition>
  <condition>Type 2 Diabetes</condition>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Normal Weight</arm_group_label>
    <description>Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overweight/Obese</arm_group_label>
    <description>Overweight and normoglycemic women: Pre-pregnancy BMI between &gt; 25 kg/m2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gestational Diabetes</arm_group_label>
    <description>Women who develop gestational diabetes and return to normal glucose control after delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
    <description>Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI &gt; 25 kg/m2.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human Milk, Plasma, Urine and Stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit pregnant women in the Denver Colorado area who plan to deliver their infant&#xD;
        at the University of Colorado Hospital, and plan to exclusively breastfeed their infant for&#xD;
        at least 5 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 28-40 weeks gestation&#xD;
&#xD;
          -  Plan to Exclusively Breastfeed for at least 5 months&#xD;
&#xD;
          -  Between 20 - 35 years old&#xD;
&#xD;
          -  Carrying a singleton pregnancy&#xD;
&#xD;
          -  Parity less than or equal to 5&#xD;
&#xD;
          -  Pre-pregnancy BMI between 18.5 and 39.9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No known infant anomalies or birth defects&#xD;
&#xD;
          -  Maternal Type 1 Diabetes&#xD;
&#xD;
          -  Maternal major medical condition (ie: Kidney Disease or Pre-eclampsia)&#xD;
&#xD;
          -  Delivery of the infant before 35 weeks gestation&#xD;
&#xD;
          -  Smoking During pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy F Krebs, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda A Barbour, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <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>November 2020</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>November 19, 2020</last_update_submitted>
  <last_update_submitted_qc>November 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>human milk</keyword>
  <keyword>infant growth</keyword>
  <keyword>obesity</keyword>
  <keyword>diabetes</keyword>
  <keyword>breastfeeding</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/NCT01693406
org study id: 12-0629
nct id: NCT01693406
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Childhood obesity is a critical global public health concern. Breastfeeding is the ideal
      choice for infant nutrition. However, rapid and excess weight gain during infancy predicts
      later, even among breastfed infants. This risk is higher if mothers are obese and/or
      diabetic. Composition of bioactive components of breast milk may differ based between mothers
      who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are
      associated with overall increases in inflammation and oxidative stress, but how breast milk
      composition is affected remains unknown. The investigators overarching goal is to determine
      how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how
      differences in composition may impact infant growth and fat development. The investigators
      are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and
      20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The
      investigators will track infant weight and fat gain and monitor maternal glucose control. The
      investigators will also collect breast milk samples over the first 4 months and measure
      concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and
      nutrient composition in milk. The investigators predict that concentrations of
      growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and
      markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast
      milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers'
      breast milk. The investigators expect these differences will be most pronounced in the first
      2 weeks after birth. The investigators also predict that breast milk concentrations of these
      biomarkers will be associated with infant fat gain. What the investigators find will help
      understand how early infant nutrition and growth may affect that child's later risk of
      obesity.
observational model: Cohort
time perspective: Prospective
measure: Change in infant percent body fat from birth to 4 months
time frame: Birth, 2 weeks, 1, 2, 3, and 4 months
description: Body composition is measured by skin folds and air displacement plethysmography (PeaPod)
measure: Change in Human Milk Hormone Composition
time frame: 2 weeks, 1, 2, 3, and 4 months
description: The investigators will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points
measure: Change in Human Milk cytokine content
time frame: 2 weeks, 1, 2, 3, and 4 months
description: The investigators will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points
measure: Change in Antioxidant capacity of human milk
time frame: 2 weeks, 1, 2, 3, and 4 months
description: The investigators will analyze: TBARS, 8-OH-dG, HNE, and F2-isoprostane concentrations and total antioxidant capacity in human milk samples collected at these time points.
measure: Change in Human Milk Nutrient Composition
time frame: 2 weeks, 1, 2, 3, and 4 months
description: The investigators will analyze: glucose, percent fat, protein and caloric content of human milk samples collected at these time points.
arm group label: Normal Weight
description: Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.
arm group label: Overweight/Obese
description: Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2.
arm group label: Gestational Diabetes
description: Women who develop gestational diabetes and return to normal glucose control after delivery.
arm group label: Type 2 Diabetes
description: Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI > 25 kg/m2.
Human Milk, Plasma, Urine and Stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nancy F Krebs, MD, MS
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Linda A Barbour, MD, MSPH
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus