Effects of Stress on Glucose Tolerance During Pregnancy

NCT ID: NCT01707784

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Stress Gestational Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Women with gestational diabetes

Women with gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing

No interventions assigned to this group

Women without gestational diabetes

Women without gestational diabetes diagnosed by clinically routine 75 g oral glucose tolerance testing

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jardena Puder

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jardena J. Puder, MD

Role: STUDY_DIRECTOR

University of Lausanne

Ji-Seon Kang

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Yvan Vial, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Pr Ulrike Ehlert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Ayala Borghini, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Pedro Marques-Vidal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maternité CHUV, University of Lausanne

Lausanne, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

295/12

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.