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Completed

NCT Number: NCT01707784

Effects of Stress on Glucose Tolerance During Pregnancy

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.

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Key information

Conditions

Pregnancy Anxiety Disorders Diabetes Insipidus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pituitary Diseases Pregnancy Complications Stress Urogenital Diseases Urologic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Maternité CHUV, University of Lausanne

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Markers of stress

    Time frame: At assessment

    stress (stressful life events, the perceived level of stress and the cortisol or copeptin concentrations)

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2017
First posted
Oct 16, 2012
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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