Trials Sponsors Conditions Drugs Pricing

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Insulin-regulated aminopeptidasegestational diabetes mellitusglucose transporter 4insulin resistanceglycated 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

Age21 Years - 41 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodProbability 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.

Sponsors & Collaborators

OSMAN KÖSE, MD
Otherlead

Study Sites (1)

Sakarya University Faculty of Medicine

Adapazarı, Sakarya, 54290, Turkey (Türkiye)

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: 38001104RESULT

MeSH Terms

Conditions

Diabetes, GestationalInsulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

Osman köse, ass. Prof.
Sakarya University Faculty of Medicine
STUDY DIRECTOR

Enrollment

80 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Group gestational diabetes mellitus, Group Healthy pregnant women

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Group gestational diabetes mellitus, Group Healthy pregnant women

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations