- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798377
Maternal Stress and Blood Sugar Metabolization
June 14, 2023 updated by: Sanford Health
Maternal Stress and Blood Sugar Metabolization During Pregnancy
During pregnancy, gestational diabetes increases the risk of complications and adverse outcomes for mother and child, however about 50% of gestational diabetes cases are diagnosed without a known risk factor present.
This project uses both a large sample retrospective study, and a prospective study to help us understand the mechanisms by which mental health and stress impact glucose metabolization during pregnancy and delineate their contribution to gestational diabetes and racial disparities.
The investigators expect, to improve the ability to identify women at risk, and advance options for preventative care and treatment, decreasing the impact of gestational diabetes and related complications.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Gestational diabetes mellitus (GDM) impacts an estimated 3% to 9% of pregnancies, increasing the risk of serious health complications for mother and child.
The identified risk factors for developing GDM include both individual characteristics (e.g., higher body mass index, advanced maternal age) and heritable factors (e.g., family history of Type 2 diabetes, historically marginalized racial/ethnic identity).
However, approximately 50% of GDM diagnoses occur in the absence of any known risk factor(s).
Additional research on biopsychosocial factors related to glucose metabolism, such as mental health and stress processes, may help to identify individuals at risk.
In this project, the investigators seek to understand the mechanisms by which mental health and stress impact glucose metabolization during pregnancy and delineate their contribution to GDM racial disparities.
The investigators hypothesize that there will be associations between maternal mental health, glucose metabolization, and GDM related adverse pregnancy outcomes that are moderated by stress, and that the magnitude of the of these associations underlay GDM health disparities experienced by African American (AA) and Native American (NA) women in comparison to non-Hispanic white (NHW) women.
This project will: 1) identify stress-related variables that moderate associations between maternal mental health and GDM-related health outcomes; 2) delineate associations among maternal mental health, stress, glucose metabolization, and related adverse outcomes, differ among AA, NA, and NHW women; and 3) increase the understanding of how psychophysiological stress reactivity interacts with maternal stress and mental health, to predict glucose metabolization during pregnancy, and associations with adverse perinatal outcomes.
A retrospective study of 4,845 de-identified pregnancy-related medical records of Sanford Health patients, and a prospective study which follows 150 pregnant women recruited from Sanford Health prenatal care providers will be conducted.
Data from medical records and prospective assessments will be used to identify associations between maternal health, mental health, blood glucose metabolization and pregnancy outcomes.
Indicators of stress will be tested as moderators in these associations.
These analyses will aid in identifying which combinations of maternal depression, anxiety, and stress, are associated with increased risk of GDM and GDM related outcomes.
The retrospective study will compare the impact of modeled associations, among women of NA, AA, and NHW heritage, with results that will provide insights as to the role of psychosocial factors in GDM related health disparities among AA and NA women.
The prospective study, participants will complete a laboratory stress task while the investigators assess physiological markers of stress reactivity, including cortisol, immunoglobulin A, c-reactive protein, and cardiovascular responses.
Results from the prospective study will provide novel information about the role of physiological pathways by which combinations of maternal mental health and stress impact blood sugar metabolization, GDM and GDM related outcomes.
By modeling pathways between maternal stress and glucose metabolism, the investigators aim to improve our ability to identify women at risk of GDM improving access to prevention and treatment, and of GDM and related complications.
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Valentina Ayala Catala
- Phone Number: 605 3126406
- Email: strahmlab@sanfordhealth.org
Study Locations
-
-
South Dakota
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Sioux Falls, South Dakota, United States, 57104
- Recruiting
- Sanford Health
-
Contact:
- Valentina Ayala Catalan
- Phone Number: 605-312-6406
- Email: valentina.ayalacatalan@sanfordhealth.org
-
Principal Investigator:
- Anna M Strahm, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The investigators will recruit 150 pregnant women prior to their 17th week of gestation from Sanford Health prenatal care providers in the Sioux Falls area.
Description
Inclusion Criteria:
- At least 18 years old
- Less than 17 weeks
- Healthy single baby pregnancy
Exclusion Criteria:
- History of diabetes
- History of Gestational diabetes mellitus (GDM)
- History of cardiac disease
- History of endocrine disease
- Assistive reproductive technology (in-vitro fertilization)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral Glucose Tolerance Test
Time Frame: Through study completion, an average of 2 years
|
Amount of glucose remaining in blood after one hour challenge
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna M Strahm, PhD, Sanford Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2023
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 23, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 14, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- SH SugarStudy23
- 5P20GM121341-04 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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