Clinical trial NCT01042210: Agouti-related Peptide (AgRP) in Healthy Mothers and Mothers With Preeclampsia and Their Offspring
Official title: Genotype-phenotype Associations of Agouti-related Peptide (AgRP) in Postpartum Period in Preeclamptic and Non-preeclamptic Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: preeclampsia
agouti-related peptide
intrauterine growth
birth weight
Intrauterine growth restriction due to preeclampsia
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the Masaryk university afilliated hospital, Clinic of Obstetrics and Gynecology,hospitalized due to preeclampsia or healthy women with uncomplicated conception, pregnancy and delivery that came to give birth at the Clinic. Along with the mothers, their offspring in included in the study. The study population originated from a static region of the Czech Republic - South Moravia.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother
timeFrame: 2-4 hours postpartum
measure: Plasma level of agouti-related peptide in umbilical cord blood from the newborn
timeFrame: immediately postpartum
Secondary outcomes:
measure: maternal weight gain during pregnancy
timeFrame: using postpartum and peripartum data
measure: birth weight of the newborn
timeFrame: immediately postpartum
measure: maternal preconceptional BMI
timeFrame: anamnestic information
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology
state: Moravia
Study officials:
affiliation: Department of Pathological Physiology, Faculty of Medicine, Masaryk University
name: Julie Bienertova-Vasku, MD.,, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pathological Physiology, Faculty of Medicine, Masaryk University
name: Anna Vasku, prof. Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Pathological Physiology, Faculty of Medicine, Masaryk University
name: Petr Bienert, Dr.
role: STUDY_DIRECTOR
References:
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. doi: 10.1159/000082735. Epub 2004 Dec 13.
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. doi: 10.1016/j.regpep.2004.08.012.
citation: 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. doi: 10.1210/jc.2004-1124. Epub 2004 Nov 16.
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. doi: 10.1111/j.1365-2265.2004.02056.x.