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Effects of Stress on Glucose Tolerance During Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01707784
First received: October 12, 2012
Last updated: May 10, 2016
Last verified: May 2016
  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 University of Lausanne Hospitals:

Primary Outcome Measures:
  • Markers of stress [ Time Frame: At assessment ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: October 12, 2012
Last Updated: May 10, 2016
Health Authority: Switzerland: Ethical committee of the canton Vaud

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016