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

NCT06716320 | Completed

• 1 other identifier: E-16214662-050.01.04-28527-89
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Insulin-regulated aminopeptidase; gestational diabetes mellitus; glucose transporter 4; insulin resistance; glycated hemoglobin

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years - 41 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• OSMAN KÖSE, MD: lead

Study Sites (1)

Sakarya University Faculty of Medicine

Adapazarı, Sakarya, 54290, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38001104 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Osman köse, ass. Prof.

  Sakarya University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: April 30, 2021
• Primary Completion: January 30, 2022
• Study Completion: April 30, 2022
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be shared with appropriate researchers after the results of the study are published.
• 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

Locations

TU (1)