NCT07231341 Insulin Resistance in Gestational Diabetes Mellitus
| NCT ID | NCT07231341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Gestational Diabetes Mellitus (GDM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-09-22 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-09-22 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Ninna L Larsen, MD
PRINCIPAL INVESTIGATOR
University of Aarhus
Frequently Asked Questions
Who can join the NCT07231341 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes Mellitus (GDM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07231341 currently recruiting?
Yes, NCT07231341 is actively recruiting participants. Contact the research team at nll@clin.au.dk for enrollment information.
Where is the NCT07231341 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herning, Denmark.
Who is sponsoring the NCT07231341 clinical trial?
NCT07231341 is sponsored by University of Aarhus. The principal investigator is Ninna L Larsen, MD at University of Aarhus. The trial plans to enroll 100 participants.
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