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NCT01707784 Clinical Trial

Effects of Stress on Glucose Tolerance During Pregnancy

Pregnancy Clinical Trial

Official title:
Effects of Stress on Glucose Tolerance During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01707784
Other study ID # 295/12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2012
Est. completion date September 2017

Study information
Verified date March 2020
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date September 2017
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Maternité CHUV, University of Lausanne Lausanne

Sponsors (1)
Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Markers of stress stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations) At assessment
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