NCT06761053

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: ALI BAHADIRLI · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Introduction Pregnancy necessitates a fine balance between pro- and anti-inflammatory processes to establish a favorable uterine environment. Disruptions in this balance, such as inflammation, are associated with adverse outcomes, including gestational diabetes mellitus (GDM). GDM prevalence varies globally, influenced by ethnicity, diagnostic criteria, and cultural differences, ranging from 1% to 28%. In Europe, the prevalence is approximately 5-10%, posing significant risks for maternal and neonatal health. Universal screening between 24-28 weeks of gestation is widely recommended. Primary GDM risk factors include advanced maternal age, obesity, and inflammation. Adipose tissue, an endocrine organ, secretes adipokines such as leptin and adiponectin, which impact glucose metabolism, particularly in obesity-related insulin resistance. Pregnancy-induced insulin resistance ensures fetal glucose supply, but insufficient pancreatic beta-cell compensation may lead to GDM. These mechanisms underscore the rationale for mid-gestation GDM screening. Although glucose tolerance tests are considered safe, concerns about glucose ingestion during pregnancy highlight the need for innovative diagnostic approaches. Given GDM's inflammatory underpinnings, markers of acute inflammation could enhance diagnostic accuracy. This study evaluates the albumin/high-sensitivity C-reactive protein (hsCRP) ratio's utility in diagnosing GDM and predicting adverse outcomes. Material and Methods Study Design and Participants This prospective clinical cohort study was conducted at a training and research hospital with ethics committee approval. Pregnant women at 24-28 weeks of gestation, determined by last menstrual period and first-trimester ultrasonography, were enrolled. The study adhered to the Declaration of Helsinki principles, with participants providing written informed consent for data collection and analysis. GDM Screening and Diagnosis The glucose challenge test (GCT) measured plasma glucose one hour after consuming 50 grams of glucose. Participants with GCT results ≥140 mg/dL underwent a 100-gram oral glucose tolerance test (OGTT) after a standardized three-day diet. OGTT diagnostic criteria included fasting plasma glucose (FPG) levels and glucose measurements at 1-hour and 2-hour intervals post-glucose ingestion, categorized per Carpenter and Coustan criteria. Some participants underwent 75-gram OGTT, with diagnostic thresholds similarly defined. Laboratory Measurements Blood samples were analyzed in the hospital laboratory. Albumin levels were measured using the bromocresol green method, and hsCRP levels were assessed using nephelometry. The albumin/hsCRP ratio was calculated accordingly. Exclusion Criteria Participants with pre-gestational diabetes, BMI \>30, age \>35, GDM history, macrosomic delivery history, unexplained fetal loss, type II diabetes family history, endocrinology diseases, liver or renal disease, or systemic/local infection were excluded. Data Collection and Review Antenatal visit records and delivery outcomes were reviewed for complications, including preeclampsia, gestational hypertension, amniotic fluid abnormalities, fetal anomalies, preterm labor, and postpartum hemorrhage. Neonatal outcomes, such as birth weight, APGAR scores, NICU admission, and stillbirth, were also assessed. Statistical Analysis The Shapiro-Wilk test assessed variable normality. Normally distributed variables were compared using Student's t-tests; non-normally distributed variables were analyzed with Mann-Whitney U tests. Categorical variables were compared using Chi-square or Fisher's exact tests. ROC curve analysis evaluated the albumin/hsCRP ratio's predictive potential, reporting AUC, sensitivity, specificity, and cut-off values. Analyses were performed using SPSS 22 and MedCalc 19.5.6, with p\<0.05 considered significant.

Conditions

• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intervention/Exposure for the GDM Group (Experimental Arm)	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.
DIAGNOSTIC_TEST	Intervention/Exposure for the Control Group	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.

Timeline

• Start date: 2021-02-03
• Primary completion: 2022-02-03
• Completion: 2022-07-03
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: Turkey (Türkiye)