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

NCT ID: NCT06716320

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes Mellitus in Pregnancy

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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OSMAN KÖSE, MD

OTHER

Sponsor Role lead

Responsible Party

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OSMAN KÖSE, MD

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Osman köse, ass. Prof.

Role: STUDY_DIRECTOR

Sakarya University Faculty of Medicine

Locations

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Sakarya University Faculty of Medicine

Adapazarı, Sakarya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 38001104 (View on PubMed)

Other Identifiers

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E-16214662-050.01.04-28527-89

Identifier Type: -

Identifier Source: org_study_id