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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03275272
Other study ID # IGF-1level in infants
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 6, 2017
Last updated September 6, 2017
Start date December 2017
Est. completion date December 2018

Study information

Verified date September 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 3 Months
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
level of IGF-1 in infants
Measurment of blood level of IGF-1 in infants

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Hansen-Pupp I, Löfqvist C, Polberger S, Niklasson A, Fellman V, Hellström 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary IGF-1 level in infants Effect of maternal BMI and type of feeding of infants on IGF-1on infants One year
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