Insulin Resistance in Gestational Diabetes Mellitus
ConditionGestational Diabetes Mellitus (GDM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Aarhus
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Pregnant women diagnosed with gestational diabetes mellitus
Trial outcomes
Primary outcomes
1
Birth weight z-scores
Calculated using reference standards adjusted for gestational age and sex. Unit of measure: z-score (SD units).
Time frame
Recorded immediately after delivery.Secondary outcomes
1
Maternal glycaemic variability, Coefficient of Variation (CV)
Coefficient of variation (%) of interstitial glucose derived from 14 consecutive days of continuous glucose monitoring (CGM).
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.2
Maternal Time in Range (TIR)
Percentage of time with blood glucose levels within the pregnancy target range (3.9 - 7.0 mmol/l) during the 14-day CGM period.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.3
Maternal Time Above Range (TAR)
Percentage of time with blood glucose levels above the pregnancy target range (3.9 - 7.0 mmol/l) during the 14-day CGM period.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.4
Maternal Time Below Range (TBR)
Percentage of time with blood glucose levels below the pregnancy target range (3.9 - 7.0 mmol/l) during the 14-day CGM period.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.Other outcomes
1
Maternal glycaemic variability, Standard Deviation (SD)
Standard deviation of interstitial glucose from continuous glucose monitoring (CGM) over 14 consecutive days. Unit of measure: mmol/L. Measurement tool: FreeStyle Libre Pro IQ.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.2
Maternal glycaemic variability, Mean Amplitude of Glycaemic Excursions (MAGE)
MAGE calculated from CGM profiles over 14 consecutive days using a standard algorithm. Unit of measure: mmol/L.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.3
Maternal glycaemic variability, J-index
J-index computed from mean glucose and SD over the 14-day CGM period, using the prespecified formula (J-index = 0.001 × (mean + SD)²). Unit of measure: mmol/L.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.4
Maternal glycaemic variability, CONGA
Continuous Overall Net Glycaemic Action (CONGA) calculated over the prespecified lag (e.g., CONGA-1 or CONGA-2) from 14-day CGM data. Unit of measure: mmol/L.
Time frame
Measurements will be commenced between gestational week 28+0 and 34+6.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov