NCT03275272

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 6, 2017

Last Update Submit

September 6, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • IGF-1 level in infants

    Effect of maternal BMI and type of feeding of infants on IGF-1on infants

    One year

Study Arms (1)

level of IGF-1 in infant

OTHER

Measurment of blood level of IGF-1 In infants

Diagnostic Test: level of IGF-1 in infants

Interventions

Measurment of blood level of IGF-1 in infants

level of IGF-1 in infant

Eligibility Criteria

Age2 Months - 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants from two to three month and thier mother

You may not qualify if:

  • VLBW. 2-preterm infants. 3-IUGR 4-mother with hormonal disturbance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 21263374BACKGROUND
  • 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.

MeSH Terms

Conditions

Insulin-Like Growth Factor I Deficiency

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Measurment of blood level of IGF-1 and Maternal BMI
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Measurment of maternal BMI and serum level if IGF-1 in infant
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nesma Mohamed Ezz ElDien Shahata

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 7, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 7, 2017

Record last verified: 2017-09