ClinicalTrials.Veeva

Menu

Decreased Insulin Regulated Aminopeptidase (IRAP) Levels in Gestational Diabetes Mellitus

O

OSMAN KÖSE, MD

Status

Completed

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT06716320
E-16214662-050.01.04-28527-89

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

21 to 41 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Group gestational diabetes mellitus, Group Healthy pregnant women
Description:
Group gestational diabetes mellitus (GDM): GDM was diagnosed according to the criteria of The International Association of Diabetes and Pregnancy Study Groups when one or more abnormal plasma glucose values were obtained (fasting ≥ 92 mg/dL, 1 h ≥ 180 mg/dL, 2 h ≥ 153 mg/dL). In pregnant women who could not achieve normoglycemia with diet, insulin treatment was started and fasting blood sugar and 1st and 2nd hour postprandial blood sugar threshold values were determined as 95 mg/dL, 140 mg/dL and 120 mg/dL, respectively. Group Healthy pregnant women: In the healthy pregnant women group, 40 pregnant women were considered normoglycemic because their 75-g OGTT tests matched the study group in terms of age, BMI, and gestational age. Pregnant women in this group who did not have any complications were included. All groups were followed until the end of birth.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems