Clinical trial NCT01707784: Effects of Stress on Glucose Tolerance During Pregnancy
Official title: Effects of Stress on Glucose Tolerance During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Stress
Gestational Diabetes
Keywords: Pregnancy
Stress
Anxiety
Cortisol
Copeptin
Gestational diabetes
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 203
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: 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.

Detailed description: Hypotheses in this study, 3 primary hypotheses will be tested.

1. Women with gestational diabetes have more life events compared to pregnant women without gestational diabetes.
2. Women with gestational diabetes have higher perceived level of stress and anxiety compared to pregnant women without gestational diabetes.
3. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Markers of stress
timeFrame: At assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Maternité CHUV, University of Lausanne
Study officials:
affiliation: University of Lausanne
name: Jardena J. Puder, MD
role: STUDY_DIRECTOR
affiliation: University of Lausanne
name: Ji-Seon Kang
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lausanne
name: Yvan Vial, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Pr Ulrike Ehlert, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lausanne
name: Ayala Borghini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lausanne
name: Pedro Marques-Vidal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: