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Not yet recruiting NCT07598149

Glucose Levels and Outcomes in Women - Mid Pregnancy

Observational Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Up to 75% of reproductive age women are overweight, 40% are considered obese, and the prevalence of gestational diabetes mellitus (GDM) continues to rise, from 6% to 8.3% between 2016 and 2021. Currently understood GDM risk factors, such as advanced maternal age, prior history of GDM, family history of diabetes, and socioeconomic status can only explain up to 50% of cases. Related factors such as body image dissatisfaction, eating behaviors, and daily stress exposure have been linked to blood sugar metabolization, pregnancy outcomes, and the normative physiological changes that occur during pregnancy. These interrelated mechanisms may serve as additional risk factors that could help identify other women at risk of GDM. This project aims to investigate how body image dissatisfaction, eating behaviors, and daily stress exposure are associated with the metabolization of blood sugar during pregnancy. In this study the Strahm Lab will recruit 50 pregnant women to participate in a study assessing blood sugar metabolization as it is related to stress, body image dissatisfaction, and eating behaviors. The study will use continuous glucose monitoring in concert with an ecological momentary assessment protocol to assess these interrelated factors over the course of 10 days between 14 and 28 weeks gestation.

Primary outcome measures

  • Continuous Blood Glucose via Dexcom G7 [Time frame: 10 days]
  • Body Image in Pregnancy Scale (BIPS) [Time frame: 10 days]

Eligibility criteria

Inclusion criteria

  • At least 18 years old
  • Healthy single baby pregnancy
  • 14 to 28 weeks of pregnancy

Exclusion criteria

  • history of diabetes
  • history of gestational diabetes mellitus (GDM)
  • history of cardiac disease
  • history of endocrine disease
  • assistive reproductive technology (IVF)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • North Dakota State University — Fargo
  • Sanford Health — Fargo
  • Sanford Health — Sioux Falls

Identifiers

NCT: NCT07598149 · SH-GLOW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗