NCT05798377

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2023Jan 2027

First Submitted

Initial submission to the registry

March 6, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

March 6, 2023

Last Update Submit

March 19, 2026

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Oral Glucose Tolerance Test

    Amount of glucose remaining in blood after one hour challenge

    Through study completion, an average of 2 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • At least 18 years old
  • Less than 17 weeks
  • Healthy single baby pregnancy

You may not qualify if:

  • History of diabetes
  • History of Gestational diabetes mellitus (GDM)
  • History of cardiac disease
  • History of endocrine disease
  • Assistive reproductive technology (in-vitro fertilization)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Study Officials

  • Anna M Strahm, PhD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 4, 2023

Study Start

May 31, 2023

Primary Completion

September 15, 2025

Study Completion (Estimated)

January 31, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)