PregnancyNCT01707784
Effects of Stress on Glucose Tolerance During Pregnancy
An observational study of Pregnancy and Stress, run by University of Lausanne Hospitals at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Stress, Gestational Diabetes
- Type of treatment
- Pill or oral medicine
- How many people
- 203 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- To test the link between these stress measures and the fasting and stimulated glucose levels during the oral glucose tolerance test.
- Conditions
- Pregnancy, Stress, Gestational Diabetes
- Keywords
- Pregnancy, Stress, Anxiety, Cortisol, Copeptin, Gestational diabetes
- Medical subject headings
- Diabetes, Gestational, Anxiety Disorders, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of stress
stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)
Measured: At assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jardena Puder, University of Lausanne Hospitals
- Investigators
- Jardena J. Puder, MD, Study director, University of LausanneJi-Seon Kang, Principal investigator, University of LausanneYvan Vial, MD, Principal investigator, University of LausannePr Ulrike Ehlert, PhD, Principal investigator, University of ZurichAyala Borghini, PhD, Principal investigator, University of LausannePedro Marques-Vidal, MD, PhD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707784
- Sponsor's protocol ID
- 295/12
- Status last verified
- Mar 2020
- First submitted
- 12 Oct 2012
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stress on Glucose Tolerance During Pregnancy
- ClinicalTrials.gov ID
- NCT01707784
- Acronym / sponsor ID
- 295/12
- Conditions
- Pregnancy, Stress, Gestational Diabetes
- Keywords
- Pregnancy, Stress, Anxiety, Cortisol, Copeptin, Gestational diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- To test the link between these stress measures and the fasting and stimulated glucose levels during the oral glucose tolerance test.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Markers of stress
Time frame: At assessment
stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jardena J. Puder, MD study director
University of Lausanne
Ji-Seon Kang principal investigator
University of Lausanne
Yvan Vial, MD principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Stress, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of stress (time frame: At assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.