PreeclampsiaNCT01042210
Agouti-related Peptide (AgRP) in Healthy Mothers and Mothers With Preeclampsia and Their Offspring
An observational study of Preeclampsia, run by Masaryk University at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 84 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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:
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- uncomplicated
- spontaneous conception
- single-fetus pregnancy
- age range 18-35 y
- spontaneous uncomplicated delivery
- no history of preconceptional hypertension
Who cannot join
- For preeclampsia:
- multiple pregnancy
- preeclampsia superimposed to chronic hypertension preceding pregnancy
- kidney disease
- fetal malformations
- For mothers with physiological pregnancies:
Show all 10Show fewer
- in vitro fertilization
- fetal malformations
- multiple pregnancy
- events of bleeding
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masaryk university affiliated hospital, Clinic of Obstetrics and Gynecology
Brno, Moravia, 625 00
About this study
Official title: Genotype-phenotype Associations of Agouti-related Peptide (AgRP) in Postpartum Period in Preeclamptic and Non-preeclamptic Women and Their Offspring
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.
Read the 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.
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, agouti-related peptide, intrauterine growth, birth weight, Intrauterine growth restriction due to preeclampsia
- Medical subject headings
- Pre-Eclampsia, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother
Measured: 2-4 hours postpartum
Plasma level of agouti-related peptide in umbilical cord blood from the newborn
Measured: immediately postpartum
Secondary outcomes (3)
maternal weight gain during pregnancy
Measured: using postpartum and peripartum data
birth weight of the newborn
Measured: immediately postpartum
maternal preconceptional BMI
Measured: anamnestic information
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2005
- Primary completionMar 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Investigators
- Julie Bienertova-Vasku, MD.,, Ph.D., Principal investigator, Department of Pathological Physiology, Faculty of Medicine, Masaryk UniversityAnna Vasku, prof. Ph.D., Study director, Department of Pathological Physiology, Faculty of Medicine, Masaryk UniversityPetr Bienert, Dr., Study director, Department of Pathological Physiology, Faculty of Medicine, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042210
- Sponsor's protocol ID
- MU-JBV-PPM1
- Status last verified
- Nov 2009
- First submitted
- 4 Jan 2010
- Last updated
- 5 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15604600Tamura 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.
PubMed 15582725Gavrila 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.
PubMed 15546902Hoggard 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.
PubMed 15212642
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotype-phenotype Associations of Agouti-related Peptide (AgRP) in Postpartum Period in Preeclamptic and Non-preeclamptic Women and Their Offspring
- ClinicalTrials.gov ID
- NCT01042210
- Acronym / sponsor ID
- MU-JBV-PPM1
- Conditions
- Preeclampsia
- Keywords
- preeclampsia, agouti-related peptide, intrauterine growth, birth weight, Intrauterine growth restriction due to preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (12 listed)
- For preeclampsia:
- For mother with physiological pregnancies:
Key exclusion criteria (10 listed)
- For preeclampsia:
- For mothers with physiological pregnancies:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother
Time frame: 2-4 hours postpartum
Plasma level of agouti-related peptide in umbilical cord blood from the newborn
Time frame: immediately postpartum
3 secondary outcomes
maternal weight gain during pregnancy
Time frame: using postpartum and peripartum data
birth weight of the newborn
Time frame: immediately postpartum
maternal preconceptional BMI
Time frame: anamnestic information
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2010.
- Background: PubMed 15604600Wagner 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.
- Background: PubMed 15582725Tamura 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.
- Background: PubMed 15546902Gavrila 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.
- Background: PubMed 15212642Hoggard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Bienertova-Vasku, MD.,, Ph.D. principal investigator
Department of Pathological Physiology, Faculty of Medicine, Masaryk University
Anna Vasku, prof. Ph.D. study director
Department of Pathological Physiology, Faculty of Medicine, Masaryk University
Petr Bienert, Dr. study director
Department of Pathological Physiology, Faculty of Medicine, Masaryk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma/serum level of agouti/related peptide in peripheral blood in postpartum mother (time frame: 2-4 hours postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042210, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2010.