Insulin Resistance in Gestational Diabetes Mellitus

NCT07231341 | Recruiting

• 1 other identifier: 1-10-72-350-21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

GDM; Gestational diabetes mellitus; CGM; Continuous glucose monitoring; Pregnancy; Diabetes in pregnancy

Outcome Measures

Primary Outcomes (1)

• Birth weight z-scores

  Calculated using reference standards adjusted for gestational age and sex. Unit of measure: z-score (SD units).

  Recorded immediately after delivery.

Secondary Outcomes (9)

• Maternal glycaemic variability, Coefficient of Variation (CV)

  Measurements will be commenced between gestational week 28+0 and 34+6.

• Maternal Time in Range (TIR)

  Measurements will be commenced between gestational week 28+0 and 34+6.

• Maternal Time Above Range (TAR)

  Measurements will be commenced between gestational week 28+0 and 34+6.

• Maternal Time Below Range (TBR)

  Measurements will be commenced between gestational week 28+0 and 34+6.

• 2-hour oral glucose tolerance test (OGTT)

  Measured at diagnosis of gestational diabetes mellitus.

Other Outcomes (6)

• Maternal glycaemic variability, Standard Deviation (SD)

  Measurements will be commenced between gestational week 28+0 and 34+6.

• Maternal glycaemic variability, Mean Amplitude of Glycaemic Excursions (MAGE)

  Measurements will be commenced between gestational week 28+0 and 34+6.

• Maternal glycaemic variability, J-index

  Measurements will be commenced between gestational week 28+0 and 34+6.

Study Arms (1)

Pregnant women diagnosed with gestational diabetes mellitus

Continuous glucose monitoring for 14 days during pregnancy in women diagnosed with gestational diabetes mellitus. Delivery data are recorded, thus participants are followed up to 12 weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stated in eligibility criteria. According to in- and exculsion criteria the study population will be singleton pregnant women \> 18 years of age, with gestational diabetes mellitus (GDM) between gestational age (GA) 28+0 and 34+6, without poorly controlled chronic diseases who are non-smokers and not treated with systemic corticosteroids.

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Gødstrup Hospital

Herning, 7400, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma/serum retained.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ninna L Larsen, MD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ninna L Larsen, MD

CONTACT

0045 26533336; nll@clin.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 17, 2025
• Study Start: September 22, 2022
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)