- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Lausanne, Sveits, 1011
- Maternité CHUV, University of Lausanne
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Markers of stress
Tidsramme: At assessment
|
stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)
|
At assessment
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Jardena J. Puder, MD, University of Lausanne
- Hovedetterforsker: Ji-Seon Kang, University of Lausanne
- Hovedetterforsker: Yvan Vial, MD, University of Lausanne
- Hovedetterforsker: Pr Ulrike Ehlert, PhD, University of Zurich
- Hovedetterforsker: Ayala Borghini, PhD, University of Lausanne
- Hovedetterforsker: Pedro Marques-Vidal, MD, PhD, University of Lausanne
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 295/12
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