<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/NCT03275272</url>
  </required_header>
  <id_info>
    <org_study_id>IGF-1level in infants</org_study_id>
    <nct_id>NCT03275272</nct_id>
  </id_info>
  <brief_title>Effect of Maternal BMI and Type of Infants Feeding on IGF-1 in Infant</brief_title>
  <official_title>Effect of maternalBMI and Type of Infants Feeding on IGF-1in Infants as Early Marker of Childand Adult Hood Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      IGF-I is a mitogenic and antiapoptotic. paracrine growth factor expressed in all fetal organ.&#xD;
      and is essential in fetal and neonatal growth, differentiation and development Several lines&#xD;
      of evidence suggest that IGF-I levels are associated with birth weight -furthermore higher&#xD;
      IGF-I levels are associated with higher BW, but not with lower birth weight]. In adulthood,&#xD;
      elevated concentrations of IGF-I are associated with an increased risk of obesity and many&#xD;
      cancers, including breast, lung, head and neck, colorectal, pancreas, synovial sarcoma, and&#xD;
      prostate canc. Although concentrations of circulating IGF-I levels vary considerably by&#xD;
      race/ethnicity and maternal pre-pregnancy obesity, few studies included African American&#xD;
      women an ethnic group that has an almost 9% higher BMI than European-American women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For healthy mother ,breastfeeding represent the gold standard for infant health, and infant&#xD;
      formula development aims at mimicking the physiological response to human milk intake. while&#xD;
      protein content is essential to promote growth and brain development, protein intakes in late&#xD;
      infancy have been found to be quite high and to exceed required intakes by large margins&#xD;
      )Ohlund and ,Hernell , 2010)&#xD;
&#xD;
      More over ,high protein intake was associated with increased weight gain and higher adiposity&#xD;
      in infancy and child hood )Singhal and kennedy , 2010 ) further more, protein intake of&#xD;
      breast-fed infant is generally lowerand may relate to lower risk of obesity later in&#xD;
      life)Harder and Betgmann , 2005 )&#xD;
&#xD;
      one potential mechanism involves an enhanced stimulation of the secretion of Insulin growth&#xD;
      factor(IGF-1)strophic hormone involved in longitudinal growth as well as muscle and fat mass&#xD;
      development (Rolland et el,1995 )&#xD;
&#xD;
      • General research statement and Justification of the research&#xD;
&#xD;
      A-Maternal BMI and IGF-1 level in infants There's a positive association among term infant&#xD;
      with elevated IGF-1 level and increased risk with higher birthweight. This positive&#xD;
      association most apparent in infant born to obese women PubMed).&#xD;
&#xD;
      Maternal obesity is rising with subsequent increase risk of childhood obesity offspring of&#xD;
      overweight and obese women (whit Take ,2004 )&#xD;
&#xD;
      Obese women have difficulties in initiating and maintaining breastfeeding because of defects&#xD;
      in their hormonal response to suckling. (Rasmussen and kjolhede , 2004 )&#xD;
&#xD;
      B-Type of Feeding And IGF-1 level in infant Breastfed infant tend to be smaller and have&#xD;
      lower endogenous production of IGF-1 than formula fed infant this attributed to their higher&#xD;
      protein content of formula(SOCHA ET Al2011) how ever this relation reverse as childhood&#xD;
      progress at age 17 young adult hood who has breastfed had higher IGF-1) than the formula fed&#xD;
      (LANKAERET Al 2009) Large Danish birth cohort reported that IGF-1 concentration at age 3month&#xD;
      were higher in formula feeding infants than in breastfeeding infants (CHellakooty et al.,&#xD;
      2006 ).&#xD;
&#xD;
      Nutritional view on breast feeding Posted on July 14, 2013 by Thomas Sherman&#xD;
&#xD;
      C-Relationship between IGF-1 and Childhood obesity and adulthood obesity. Rapid growth in&#xD;
      infancy is associated with later over weight and obesity Faster weight gain during infancy is&#xD;
      associated with increased risk of subsequent obesity and related metabolic traits&#xD;
      (Longitudinal birth cohort study and analysis pediatr Res 2002;52:863-7)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Measurment of maternal BMI and serum level if IGF-1 in infant</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Measurment of blood level of IGF-1 and Maternal BMI</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>IGF-1 level in infants</measure>
    <time_frame>One year</time_frame>
    <description>Effect of maternal BMI and type of feeding of infants on IGF-1on infants</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>IGF1 Deficiency</condition>
  <arm_group>
    <arm_group_label>level of IGF-1 in infant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Measurment of blood level of IGF-1 In infants</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>level of IGF-1 in infants</intervention_name>
    <description>Measurment of blood level of IGF-1 in infants</description>
    <arm_group_label>level of IGF-1 in infant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants from two to three month and thier mother&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1 -VLBW. 2-preterm infants. 3-IUGR 4-mother with hormonal disturbance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Hansen-Pupp I, Lofqvist C, Polberger S, Niklasson A, Fellman V, Hellstrom A, Ley D. Influence of insulin-like growth factor I and nutrition during phases of postnatal growth in very preterm infants. Pediatr Res. 2011 May;69(5 Pt 1):448-53. doi: 10.1203/PDR.0b013e3182115000.</citation>
    <PMID>21263374</PMID>
  </reference>
  <results_reference>
    <citation>Lineham JD, Smith RM, Dahlenburg GW, King RA, Haslam RR, Stuart MC, Faull L. Circulating insulin-like growth factor I levels in newborn premature and full-term infants followed longitudinally. Early Hum Dev. 1986 Feb;13(1):37-46. doi: 10.1016/0378-3782(86)90096-4.</citation>
    <PMID>3956421</PMID>
  </results_reference>
  <results_reference>
    <citation>Hikino S, Ihara K, Yamamoto J, Takahata Y, Nakayama H, Kinukawa N, Narazaki Y, Hara T. Physical growth and retinopathy in preterm infants: involvement of IGF-I and GH. Pediatr Res. 2001 Dec;50(6):732-6. doi: 10.1203/00006450-200112000-00017.</citation>
    <PMID>11726732</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>N M Shahata</investigator_full_name>
    <investigator_title>Nesma Mohamed Ezz ElDien Shahata</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03275272
org study id: IGF-1level in infants
nct id: NCT03275272
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
IGF-I is a mitogenic and antiapoptotic. paracrine growth factor expressed in all fetal organ.
      and is essential in fetal and neonatal growth, differentiation and development Several lines
      of evidence suggest that IGF-I levels are associated with birth weight -furthermore higher
      IGF-I levels are associated with higher BW, but not with lower birth weight]. In adulthood,
      elevated concentrations of IGF-I are associated with an increased risk of obesity and many
      cancers, including breast, lung, head and neck, colorectal, pancreas, synovial sarcoma, and
      prostate canc. Although concentrations of circulating IGF-I levels vary considerably by
      race/ethnicity and maternal pre-pregnancy obesity, few studies included African American
      women an ethnic group that has an almost 9% higher BMI than European-American women
For healthy mother ,breastfeeding represent the gold standard for infant health, and infant
      formula development aims at mimicking the physiological response to human milk intake. while
      protein content is essential to promote growth and brain development, protein intakes in late
      infancy have been found to be quite high and to exceed required intakes by large margins
      )Ohlund and ,Hernell , 2010)

      More over ,high protein intake was associated with increased weight gain and higher adiposity
      in infancy and child hood )Singhal and kennedy , 2010 ) further more, protein intake of
      breast-fed infant is generally lowerand may relate to lower risk of obesity later in
      life)Harder and Betgmann , 2005 )

      one potential mechanism involves an enhanced stimulation of the secretion of Insulin growth
      factor(IGF-1)strophic hormone involved in longitudinal growth as well as muscle and fat mass
      development (Rolland et el,1995 )

      • General research statement and Justification of the research

      A-Maternal BMI and IGF-1 level in infants There's a positive association among term infant
      with elevated IGF-1 level and increased risk with higher birthweight. This positive
      association most apparent in infant born to obese women PubMed).

      Maternal obesity is rising with subsequent increase risk of childhood obesity offspring of
      overweight and obese women (whit Take ,2004 )

      Obese women have difficulties in initiating and maintaining breastfeeding because of defects
      in their hormonal response to suckling. (Rasmussen and kjolhede , 2004 )

      B-Type of Feeding And IGF-1 level in infant Breastfed infant tend to be smaller and have
      lower endogenous production of IGF-1 than formula fed infant this attributed to their higher
      protein content of formula(SOCHA ET Al2011) how ever this relation reverse as childhood
      progress at age 17 young adult hood who has breastfed had higher IGF-1) than the formula fed
      (LANKAERET Al 2009) Large Danish birth cohort reported that IGF-1 concentration at age 3month
      were higher in formula feeding infants than in breastfeeding infants (CHellakooty et al.,
      2006 ).

      Nutritional view on breast feeding Posted on July 14, 2013 by Thomas Sherman

      C-Relationship between IGF-1 and Childhood obesity and adulthood obesity. Rapid growth in
      infancy is associated with later over weight and obesity Faster weight gain during infancy is
      associated with increased risk of subsequent obesity and related metabolic traits
      (Longitudinal birth cohort study and analysis pediatr Res 2002;52:863-7)
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Measurment of maternal BMI and serum level if IGF-1 in infant
primary purpose: Screening
masking: None (Open Label)
masking description: Measurment of blood level of IGF-1 and Maternal BMI
measure: IGF-1 level in infants
time frame: One year
description: Effect of maternal BMI and type of feeding of infants on IGF-1on infants
arm group label: level of IGF-1 in infant
arm group type: Other
description: Measurment of blood level of IGF-1 In infants
intervention type: Diagnostic Test
intervention name: level of IGF-1 in infants
description: Measurment of blood level of IGF-1 in infants
arm group label: level of IGF-1 in infant
criteria: 
gender: All
minimum age: 2 Months
maximum age: 3 Months
healthy volunteers: Accepts Healthy Volunteers
citation: Hansen-Pupp I, Lofqvist C, Polberger S, Niklasson A, Fellman V, Hellstrom A, Ley D. Influence of insulin-like growth factor I and nutrition during phases of postnatal growth in very preterm infants. Pediatr Res. 2011 May;69(5 Pt 1):448-53. doi: 10.1203/PDR.0b013e3182115000.
PMID: 21263374
citation: Lineham JD, Smith RM, Dahlenburg GW, King RA, Haslam RR, Stuart MC, Faull L. Circulating insulin-like growth factor I levels in newborn premature and full-term infants followed longitudinally. Early Hum Dev. 1986 Feb;13(1):37-46. doi: 10.1016/0378-3782(86)90096-4.
PMID: 3956421
citation: Hikino S, Ihara K, Yamamoto J, Takahata Y, Nakayama H, Kinukawa N, Narazaki Y, Hara T. Physical growth and retinopathy in preterm infants: involvement of IGF-I and GH. Pediatr Res. 2001 Dec;50(6):732-6. doi: 10.1203/00006450-200112000-00017.
PMID: 11726732
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: N M Shahata
investigator title: Nesma Mohamed Ezz ElDien Shahata
sharing ipd: Undecided