- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01707784
Effects of Stress on Glucose Tolerance During Pregnancy
The objective of the study is to investigate the effect of stress on glucose tolerance during pregnancy.
The main objectives of the study are to investigate if various measures of stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations) differ between pregnant women with and without gestational diabetes during the end of the second/beginning of the third trimester when presenting for their routine glucose tolerance testing.
Secondary objectives are the link between these different stress measures and the routinely measured fasting and stimulated glucose levels during the oral glucose tolerance test.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Hypotheses in this study, 3 primary hypotheses will be tested.
- Women with gestational diabetes have more life events compared to pregnant women without gestational diabetes.
- Women with gestational diabetes have higher perceived level of stress and anxiety compared to pregnant women without gestational diabetes.
- Women with gestational diabetes have higher measures of cortisol levels in the saliva and in the nailfolds and higher plasma copeptin levels compared to pregnant women without gestational diabetes.
Secondary objectives:
1. To test the link between these stress measures and the fasting and stimulated glucose levels during the oral glucose tolerance test.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Lausanne, Schweiz, 1011
- Maternité CHUV, University of Lausanne
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All pregnant women who are undergoing a 75 g oral glucose tolerance test at the "Maternité" of CHUV at 24-30 weeks of gestation between October 2012 and April 2013
Exclusion Criteria:
- Pregnant woman who has the use if medications that influence either the cortisol and /or the glucose levels
- Pregnant woman who has the inability to fill out the questionnaires with assistance
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Women with gestational diabetes
Women with gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
|
Women without gestational diabetes
Women without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Markers of stress
Tidsramme: At assessment
|
stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)
|
At assessment
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Jardena J. Puder, MD, University of Lausanne
- Ledende efterforsker: Ji-Seon Kang, University of Lausanne
- Ledende efterforsker: Yvan Vial, MD, University of Lausanne
- Ledende efterforsker: Pr Ulrike Ehlert, PhD, University of Zurich
- Ledende efterforsker: Ayala Borghini, PhD, University of Lausanne
- Ledende efterforsker: Pedro Marques-Vidal, MD, PhD, University of Lausanne
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 295/12
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