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

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Sakarya
    • Adapazarı, Sakarya, Turkey, 54290
      • Sakarya University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Group gestational diabetes mellitus, Group Healthy pregnant women; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of serum IRAP levels	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.	up to 1 year
Evaluation of serum in the pregnant women at 24-28 weeks in ng/ml.	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.	up to 1 year

Collaborators and Investigators

• Sponsor: OSMAN KÖSE, MD
• Investigators: Study Director: Osman köse, ass. Prof., Sakarya University Faculty of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: insulin resistance; gestational diabetes mellitus; glycated hemoglobin; Insulin-regulated aminopeptidase; glucose transporter 4
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus; Pregnancy in Diabetics
• Other Study ID Numbers: E-16214662-050.01.04-28527-89

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data (IPD) will be shared. Data to be shared will include age, gender, and clinical outcomes. Data will be shared with appropriate researchers after the results of the study are published. Data requests will be evaluated within the framework of relevant ethical rules.
• IPD Sharing Time Frame: The data will be shared with appropriate researchers after the results of the study are published.
• IPD Sharing Access Criteria: The full dataset or specific requested data will be accessible to researchers conducting academic research upon request or through data-sharing platforms for a period of 3 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No