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Effects of Stress on Glucose Tolerance During Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707784
First Posted: October 16, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
  Purpose

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.


Condition
Pregnancy Stress Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effects of Stress on Glucose Tolerance During Pregnancy

Further study details as provided by Jardena Puder, University of Lausanne Hospitals:

Primary Outcome Measures:
  • Markers of stress [ Time Frame: At assessment ]
    stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: September 2017
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707784


Locations
Switzerland
Maternité CHUV, University of Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Director: Jardena J. Puder, MD University of Lausanne
Principal Investigator: Ji-Seon Kang University of Lausanne
Principal Investigator: Yvan Vial, MD University of Lausanne
Principal Investigator: Pr Ulrike Ehlert, PhD University of Zurich
Principal Investigator: Ayala Borghini, PhD University of Lausanne
Principal Investigator: Pedro Marques-Vidal, MD, PhD University of Lausanne
  More Information

Responsible Party: Jardena Puder, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01707784     History of Changes
Other Study ID Numbers: 295/12
First Submitted: October 12, 2012
First Posted: October 16, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Jardena Puder, University of Lausanne Hospitals:
Pregnancy
Stress
Anxiety
Cortisol
Copeptin
Gestational diabetes

Additional relevant MeSH terms:
Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases