Clinical trial NCT06716320: Decreased Insulin Regulated Aminopeptidase (IRAP) Levels in Gestational Diabetes Mellitus
Official title: Maternal Serum Insulin-Regulated Aminopeptidase (IRAP) Levels in Gestational Diabetic Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: Insulin-regulated aminopeptidase
gestational diabetes mellitus
glucose transporter 4
insulin resistance
glycated hemoglobin
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Singleton pregnancies undergoing a 2-hour 75 g oral glucose tolerance test (OGTT) at 24 and 28 weeks of gestation

Brief summary: This cohort study investigated whether IRAP levels could be a marker for predicting gestational diabetes mellitus. 80 women were included in the study, including the control group. The study duration was 12 months and the study was completed.

Detailed description: In the cohort study, the study group (GDM group) consisted of 40 pregnant women diagnosed with GDM between 24-28 weeks of gestation with a 2-hour 75-g oral glucose tolerance test (OGTT). While 11 women in the GDM group received insulin treatment, 29 of them provided blood sugar regulation with diet. The 75-g OGTT tests of the 40 pregnant women in the control group were considered normoglycemic while matching with the study group in terms of age, BMI and gestational weeks, and no complications were observed in the pregnant women in this group. Pregnant women with preeclampsia, chronic hypertension, pre-gestational diabetes mellitus, any acute or chronic disease, premature birth, premature rupture of membranes (PPROM), fetal structural or chromosomal anomalies, multiple pregnancies and fetal growth restriction were not included in the study. The ELISA method determined Serum IRAP levels.

Serum IRAP levels of pregnant women were measured with enzyme-linked immunosorbent assay. Serum levels of IRAP marker were compared between the groups.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancies undergoing a 2-hour 75 g oral glucose tolerance test (OGTT) at 24 and 28 weeks of gestation.

Exclusion Criteria:

* Preeclampsia, chronic hypertension, pregestational diabetes mellitus, pregnant women with any acute or chronic disease, preterm labor, premature rupture of membranes (PPROM), fetal structural or chromosomal anomalies, multiple pregnancies, and fetal growth restriction

Primary outcomes:
measure: Comparison of serum IRAP levels
timeFrame: up to 1 year
measure: Evaluation of serum in the pregnant women at 24-28 weeks in ng/ml.
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Adapazarı
country: Turkey
facility: Sakarya University Faculty of Medicine
state: Sakarya
Study officials:
affiliation: Sakarya University Faculty of Medicine
name: Osman köse, ass. Prof.
role: STUDY_DIRECTOR
References:
citation: Vear A, Thalmann C, Youngs K, Hannan N, Gaspari T, Chai SY. Development of a sandwich ELISA to detect circulating, soluble IRAP as a potential disease biomarker. Sci Rep. 2023 Nov 24;13(1):17565. doi: 10.1038/s41598-023-44038-1.