PregnancyNCT05798377
Maternal Stress and Blood Sugar Metabolization
An observational study of Pregnancy, run by Sanford Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- At least 18 years old
- Less than 17 weeks
- Healthy single baby pregnancy
Who cannot join
- History of diabetes
- History of Gestational diabetes mellitus (GDM)
- History of cardiac disease
- History of endocrine disease
- Assistive reproductive technology (in-vitro fertilization)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Glucose Tolerance Test
Amount of glucose remaining in blood after one hour challenge
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start31 May 2023
- Primary completion15 Sep 2025
- Study completion31 Jan 2027 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Anna M Strahm, PhD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798377
- Sponsor's protocol ID
- SH SugarStudy23
- Other IDs
- 5P20GM121341-04
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Stress and Blood Sugar Metabolization During Pregnancy
- ClinicalTrials.gov ID
- NCT05798377
- Acronym / sponsor ID
- SH SugarStudy23
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Apr 2023 (actual)
- 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- At least 18 years old
- Less than 17 weeks
- Healthy single baby pregnancy
Key exclusion criteria (5 listed)
- History of diabetes
- History of Gestational diabetes mellitus (GDM)
- History of cardiac disease
- History of endocrine disease
- Assistive reproductive technology (in-vitro fertilization)
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
Oral Glucose Tolerance Test
Time frame: Through study completion, an average of 2 years
Amount of glucose remaining in blood after one hour challenge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Anna M Strahm, PhD principal investigator
Sanford Health
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, run by Sanford Health at 1 site in United States.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Oral Glucose Tolerance Test (time frame: Through study completion, an average of 2 years). 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 20 Mar 2026.