- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275272
Effect of Maternal BMI and Type of Infants Feeding on IGF-1 in Infant
Effect of maternalBMI and Type of Infants Feeding on IGF-1in Infants as Early Marker of Childand Adult Hood Obesity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- infants from two to three month and thier mother
Exclusion Criteria:
- 1 -VLBW. 2-preterm infants. 3-IUGR 4-mother with hormonal disturbance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: level of IGF-1 in infant
Measurment of blood level of IGF-1 In infants
|
Measurment of blood level of IGF-1 in infants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IGF-1 level in infants
Time Frame: One year
|
Effect of maternal BMI and type of feeding of infants on IGF-1on infants
|
One year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IGF-1level in infants
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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