CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 146 enrolled
Drug / intervention
Intervention/Exposure for the GDM Group (Experimental Arm) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT06761053
NCT06761053N/ACompleted

Can the Albumin/High Sensitive C-reactive Protein Ratio be Utilized for Predicting Gestational Diabetes Mellitus Diagnosis or the Adverse Outcomes

ALI BAHADIRLI·interventional·Posted Jan 7, 2025·Updated Jan 7, 2025

In Brief

A clinical study evaluating Intervention/Exposure for the GDM Group (Experimental Arm) and Intervention/Exposure for the Control Group for Gestational Diabetes Mellitus in Pregnancy. Completed, enrolled 146 participants across 1 site.

Detailed Summary

This study provides a comprehensive evaluation of the potential utility of the albumin/high-sensitivity C-reactive protein (hsCRP) ratio in diagnosing gestational diabetes mellitus (GDM) and predicting adverse pregnancy outcomes. The findings underscore the role of systemic inflammation, represented by hsCRP levels, in GDM's pathophysiology and associated complications. The results align with existing literature linking inflammation markers, such as hsCRP, to GDM and other metabolic disturbances during pregnancy. The significant differences in hsCRP and albumin/hsCRP ratios between the GDM and control groups reinforce the importance of these markers in identifying at-risk pregnancies. Moreover, the ROC analysis, with a statistically significant AUC, highlights the predictive capability of these ratios, suggesting their incorporation into clinical practice could improve early identification and management of GDM. The discussion further situates these findings within a broader context of research, emphasizing the inflammatory origins of GDM and their implications for maternal and neonatal health. Future research could explore the integration of inflammatory markers with other diagnostic tools to enhance the sensitivity and specificity of GDM screening protocols. This approach may ultimately contribute to reducing the burden of GDM-related complications and improving pregnancy outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 7, 2025
Enrollment StartFeb 3, 2021
Primary CompletionFeb 3, 2022
Study CompletionJul 3, 2022
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 1.5 years ago

Interventions

Intervention/Exposure for the GDM Group (Experimental Arm)other

Gestational Diabetes Diagnosis: The intervention for this group involves the diagnostic procedure of the 100-gram oral glucose tolerance test (OGTT) after an initial glucose challenge test (GCT) with a result equal to or greater than 140 mg/dL. The test assesses fasting plasma glucose and post-glucose consumption plasma glucose levels at 1 hour and 2 hours, which is used to diagnose GDM. Biomarker Analysis: The albumin to high-sensitivity C-reactive protein (hsCRP) ratio is measured as a biomarker to explore its potential role in GDM diagnosis and related pregnancy outcomes.

Intervention/Exposure for the Control Groupother

Glucose Challenge Test (GCT): The control group participants are exposed to the glucose challenge test (GCT), where plasma glucose levels are measured one hour after the consumption of 50 grams of glucose. If their glucose levels are below 140 mg/dL, they are categorized as not having GDM. Biomarker Analysis: Similar to the GDM group, the albumin to hsCRP ratio is measured for participants in the control group to compare the biomarker levels between those with and without GDM.