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Completed

NCT Number: NCT06716320

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

21 year–41 year

Sex eligibility

Female

Study type

Observational

Primary location

Sakarya University Faculty of Medicine

Adapazarı, Sakarya, 54290, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison of serum IRAP levels

    Time frame: up to 1 year

    Comparison of serum IRAP levels measured during the assessment between pregnant women diagnosed with gestational diabetes mellitus (GDM) based on a 75-gram OGTT performed at 24-28 weeks of gestation and normoglycemic pregnant women.

  2. Evaluation of serum in the pregnant women at 24-28 weeks in ng/ml.

    Time frame: up to 1 year

    For IRAP measurements, blood samples taken between weeks 24 and 28 were centrifuged and the serum was separated and stored at -80 ° C until the day of the study. On the day of the study, all samples were thawed at the same time and included in the study.

Sponsors and collaborators

Lead sponsor

OSMAN KÖSE, MD

Other

Registry information

Official study title

Maternal Serum Insulin-Regulated Aminopeptidase (IRAP) Levels in Gestational Diabetic Pregnant Women

Acronym: (IRAP)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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