Agouti-related Peptide (AgRP) in Healthy Mothers and Mothers With Preeclampsia and Their Offspring

Preeclampsia Clinical Trial

Official title:

Genotype-phenotype Associations of Agouti-related Peptide (AgRP) in Postpartum Period in Preeclamptic and Non-preeclamptic Women and Their Offspring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042210
• Other study ID #: MU-JBV-PPM1
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: January 4, 2010
• Start date: January 2005
• Est. completion date: December 2006

Study information

• Verified date: November 2009
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The study is focused on the investigation of possible associations between plasma/serum levels of agouti related peptide (AgRP) and its genetic background in healthy women with physiological pregnancy (non-preeclamptic) and women with preeclampsia, in the postpartum period, and in their offspring.

Description:

The study is focused on investigation of possible genotype-phenotype interactions of agouti-related peptide (AgRP) in postpartum non-preeclamptic women and preeclamptic women and in their offspring.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• For preeclampsia:

• development of hypertension after the 20th week of pregnancy (systolic blood pressure, =140 mmHg; and/or diastolic blood pressure, =90 mmHg; measured at rest on two consecutive occasions at least 24 h apart) in previously normotensive women, and the onset of proteinuria (>300 mg of urinary protein/L over 24 h)

• single-fetus pregnancy

• age range 18-35 y

• no preconceptional history of hypertension

• For mother with physiological pregnancies:

• uncomplicated

• spontaneous conception

• single-fetus pregnancy

• age range 18-35 y

• spontaneous uncomplicated delivery

• no history of preconceptional hypertension

Exclusion Criteria:

• For preeclampsia:

• multiple pregnancy

• preeclampsia superimposed to chronic hypertension preceding pregnancy

• kidney disease

• fetal malformations

• For mothers with physiological pregnancies:

• in vitro fertilization

• fetal malformations

• multiple pregnancy

• events of bleeding

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Czech Republic	Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology	Brno	Moravia

Sponsors (1)

Lead Sponsor	Collaborator
Masaryk University

Country where clinical trial is conducted

Czech Republic, 

References & Publications (4)

Gavrila A, Chan JL, Miller LC, Heist K, Yiannakouris N, Mantzoros CS. Circulating melanin-concentrating hormone, agouti-related protein, and alpha-melanocyte-stimulating hormone levels in relation to body composition: alterations in response to food deprivation and recombinant human leptin administration. J Clin Endocrinol Metab. 2005 Feb;90(2):1047-54. Epub 2004 Nov 16. — View Citation

Hoggard N, Johnstone AM, Faber P, Gibney ER, Elia M, Lobley G, Rayner V, Horgan G, Hunter L, Bashir S, Stubbs RJ. Plasma concentrations of alpha-MSH, AgRP and leptin in lean and obese men and their relationship to differing states of energy balance perturbation. Clin Endocrinol (Oxf). 2004 Jul;61(1):31-9. — View Citation

Tamura H, Kamegai J, Shimizu T, Ishii S, Sugihara H, Oikawa S. The effect of agouti-related protein on growth hormone secretion in adult male rats. Regul Pept. 2005 Feb 15;125(1-3):145-9. — View Citation

Wagner CG, McMahon CD, Marks DL, Daniel JA, Steele B, Sartin JL. A role for agouti-related protein in appetite regulation in a species with continuous nutrient delivery. Neuroendocrinology. 2004;80(4):210-8. Epub 2004 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother		2-4 hours postpartum	No
Primary	Plasma level of agouti-related peptide in umbilical cord blood from the newborn		immediately postpartum	No
Secondary	maternal weight gain during pregnancy		using postpartum and peripartum data	No
Secondary	birth weight of the newborn		immediately postpartum	No
Secondary	maternal preconceptional BMI		anamnestic information	No