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

NCT ID: NCT01042210

Last Updated: 2010-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

No interventions assigned to this group

Newborns, physiological pregnancy-delivery

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

No interventions assigned to this group

Newborns, pregnancy with preeclampsia

Newborns from the pregnancies complicated by preeclampsia.

No interventions assigned to this group

Mothers, Physiological pregnancy-labour

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Masaryk University

OTHER

Sponsor Role lead

Responsible Party

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Department of pathological physiology, Faculty of Medicine, Masaryk university, Brno

Principal Investigators

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Julie Bienertova-Vasku, MD.,, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pathological Physiology, Faculty of Medicine, Masaryk University

Anna Vasku, prof. Ph.D.

Role: STUDY_DIRECTOR

Department of Pathological Physiology, Faculty of Medicine, Masaryk University

Petr Bienert, Dr.

Role: STUDY_DIRECTOR

Department of Pathological Physiology, Faculty of Medicine, Masaryk University

Locations

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Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology

Brno, Moravia, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 15604600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15582725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15546902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15212642 (View on PubMed)

Other Identifiers

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MU-JBV-PPM1

Identifier Type: -

Identifier Source: org_study_id

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