Insulin Resistance in Gestational Diabetes Mellitus

Recruiting now

Conditions studied: Gestational Diabetes Mellitus (GDM)

In brief

This prospective cohort study investigates glycaemic variability, assessed by continuous glucose monitoring (CGM), in pregnant women with gestational diabetes mellitus (GDM) and its association with fetal growth and related maternal and neonatal outcomes. Participants will undergo 14 days of CGM during pregnancy to characterise individual glycaemic patterns. Clinical and paraclinical data, including fasting plasma glucose, HbA1c, lipid profile, organ markers of pregnancy-related medical conditions, maternal weight gain, and blood pressure will be collected at two study visits. Oral glucose tolerance test (OGTT) 2-hour values will be obtained at diagnosis. All participants will receive standard GDM care and routine obstetric follow-up for assessment of fetal growth and wellbeing. Birth weight, birth weight z-scores, and relevant neonatal outcomes will be recorded after delivery. Statistical analyses will be performed using Stata statistical software (StataCorp LLC, College Station, TX, USA). Continuous and categorical variables will be summarised using appropriate descriptive statistics. Associations between maternal glycaemic variability and neonatal as well as other maternal metabolic outcomes will be explored using suitable statistical methods, with adjustment for relevant covariates. Exploratory analyses may include additional glycaemic variability metrics and lipid parameters to further characterise maternal metabolic patterns.

Key facts

Study ID

NCT07231341

Run by

University of Aarhus

People needed

100

Starts

2022-09-22

Expected to finish

2026-04-01

Last updated by the study team

2025-11-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All singleton pregnant women with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6 attending the obstetric outpatient clinic at Aarhus University Hospital, Aarhus, Denmark or Gødstrup Hospital, Herning, Denmark will be offered participation.

You may not qualify if…

• Pre-gestational diabetes
• Age < 18 years
• Multiple pregnancies
• Chronic disease that is not well-controlled and is expected to influence study outcomes (including inflammatory diseases such as rheumatologic, gastroenterological, etc.)
• Treatment with systemic corticosteroids
• Smoking
• Women who are unable to understand the oral and written patient information

Where it is running

• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Gødstrup Hospital — Herning, Denmark (enrolling)

Full record on ClinicalTrials.gov

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