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Pregnancy Outcomes and Maternal Insulin Sensitivity

NCT04315545 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-03-30

No results posted yet for this study

Summary

The PROMIS study will focus on maternal insulin sensitivity thourghout pregnancy and postpartum in a moderate to high risk population (BMI ≥25 kg/m2) in developing adverse pregnancy outcomes. Next to the OGTT, the meal tolerance test (MTT) will be used as a tool for metabolic testing.

The investigators hypothesize that (early) pregnancy assessment of maternal glucose-insulin metabolism with a MTT in a moderate to high risk group identify more mothers at risk for adverse pregnancy outcomes compared with standard OGTT testing at 24-28 weeks.

Conditions

  • Gestational Diabetes
  • Other "Heavy-For-Dates" Infants
  • Small for Gestational Age Infant
  • Diabetes Mellitus, Type 2

Interventions

DIAGNOSTIC_TEST

meal tolerance test

In addition to the standard oral glucose tolerance (which is normally performed between 24-28 weeks of pregnancy), is used to test the metabolic resilience capacity of glucose, we will provide our participants with a different diagnostic tool named 'meal tolerance test' in an earlier stage of pregnancy (12-16 weeks), mid pregnancy (24-28 weeks) and 3 months postpartum.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Eline M van der Beek, Prof. Dr. · University Medical Center Groningen

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2024-07-08
Completion
2024-07-08

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315545 on ClinicalTrials.gov