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

NCT01042210 | Completed

• 1 other identifier: MU-JBV-PPM1
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia

Keywords

preeclampsia; agouti-related peptide; intrauterine growth; birth weight; Intrauterine growth restriction due to preeclampsia

Outcome Measures

Primary Outcomes (2)

• plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother

  2-4 hours postpartum

• Plasma level of agouti-related peptide in umbilical cord blood from the newborn

  immediately postpartum

Secondary Outcomes (3)

• maternal weight gain during pregnancy

  using postpartum and peripartum data

• birth weight of the newborn

  immediately postpartum

• maternal preconceptional BMI

  anamnestic information

Study Arms (4)

Mothers, preeclampsia

Mothers with preeclampsia diagnosed according to the Guidelines by the Czech Society of obstetrics and gynecology as 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).

Newborns, physiological pregnancy-delivery

The newborns from the physiological pregnancies with spontaneous, uncomplicated delivery.

Newborns, pregnancy with preeclampsia

Newborns from the pregnancies complicated by preeclampsia.

Mothers, Physiological pregnancy-labour

The cohort of non-preeclamptic mothers with physiological, uncomplicated conception, pregnancy and delivery.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology

Brno, Moravia, 625 00, Czechia

Location

Related Publications (4)

• 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.

  PMID: 15604600 BACKGROUND

• 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.

  PMID: 15582725 BACKGROUND

• 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.

  PMID: 15546902 BACKGROUND

• 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.

  PMID: 15212642 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, umbilical blood

MeSH Terms

Conditions

Pre-Eclampsia; Birth Weight

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Bienertova-Vasku, MD.,, Ph.D.

  Department of Pathological Physiology, Faculty of Medicine, Masaryk University

  PRINCIPAL INVESTIGATOR

• Anna Vasku, prof. Ph.D.

  Department of Pathological Physiology, Faculty of Medicine, Masaryk University

  STUDY DIRECTOR

• Petr Bienert, Dr.

  Department of Pathological Physiology, Faculty of Medicine, Masaryk University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: January 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 5, 2010

Record last verified: 2009-11

Locations

CZ (1)