Clinical trial NCT06761053: Can Albumin/C-reactive Protein Ratio be Utilized for Predicting Gestational Diabetes Diagnosis or the Adverse Outcomes
Official title: Can the Albumin/High Sensitive C-reactive Protein Ratio be Utilized for Predicting Gestational Diabetes Mellitus Diagnosis or the Adverse Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Keywords: Gestational diabetes mellitus
Albumin
C-reactive protein
Pregnancy complications
Clinical marker
Lead sponsor: Mustafa Kemalpasa Government Hospital
Sponsor class: OTHER
Collaborators: name: Bursa Yüksek İhtisas Education and Research Hospital
First posted: 2025-01-07
Enrollment: 146
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants underwent the same screening and diagnostic protocol (GCT and possibly OGTT) to assess glucose tolerance or diagnose gestational diabetes mellitus (GDM). They were not divided into separate groups to receive distinct interventions or different sequences of the same intervention.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Pregnant women between 24 and 28 weeks of gestation.
* Gestational age confirmed by both last menstrual period and first-trimester ultrasonography.
* Signed informed consent for data collection, analysis, and use for research.

Exclusion Criteria:

* Pre-gestational diabetes mellitus.
* BMI \> 30.
* Age \> 35 years.
* A history of gestational diabetes mellitus (GDM).
* Previous delivery of macrosomic infants.
* Unexplained fetal loss.
* Family history of type II diabetes mellitus.
* Any endocrinological disease.
* Liver disease, renal disease, or other significant systemic or local infections.

Primary outcomes:
measure: Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups
timeFrame: At the time of GDM diagnosis (during the 24-28 weeks of gestation) and at the end of the study.
Secondary outcomes:
measure: Prevalence of Pregnancy Complications in Women with GDM vs. Control Group
timeFrame: During pregnancy and up to delivery (final pregnancy outcome assessment).
measure: Gestational Age at Delivery in GDM vs. Control Group
timeFrame: At the time of delivery.
measure: Birth Weight and Neonatal Outcomes in GDM vs. Control Group
timeFrame: At birth (within 24 hours after delivery).
measure: Change in Plasma Glucose Levels from GCT to OGTT in GDM and Control Groups
timeFrame: During the 24-28 weeks of gestation (at the time of GCT and OGTT).
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences
Study officials:
affiliation: Bursa City Hospital
name: Ali Bahadirli, M.D.
role: PRINCIPAL_INVESTIGATOR
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