Effects of Stress on Glucose Tolerance During Pregnancy
This study is currently recruiting participants.
Verified April 2013 by University of Lausanne Hospitals
Sponsor:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01707784
First received: October 12, 2012
Last updated: April 18, 2013
Last verified: April 2013
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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 |
Resource links provided by NLM:
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 2013 |
| Estimated Primary Completion Date: | August 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.
- 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.
Eligibility| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707784
Locations
| Switzerland | |
| Maternité CHUV, University of Lausanne | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Jardena J Puder, MD +41-21-314 06 38 jardena.puder@chuv.ch | |
| Principal Investigator: Jardena J Puder, MD | |
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 Zürich |
| Principal Investigator: | Ayala Borghini, PhD | University of Lausanne |
| Principal Investigator: | Pedro Marques-Vidal, MD, PhD | University of Lausanne |
More Information
No publications provided
| 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: | April 18, 2013 |
| 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 Mellitus Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |
ClinicalTrials.gov processed this record on May 22, 2013