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Může být poměr albumin/C-reaktivní protein použit pro predikci diagnózy gestačního diabetu nebo nepříznivých výsledků (Alb/hsCRP)

4. listopadu 2026 aktualizováno: ALI BAHADIRLI, Mustafa Kemalpasa Government Hospital

Lze poměr albumin/vysoce citlivý C-reaktivní protein využít k predikci diagnózy gestačního diabetu melitus nebo nepříznivých výsledků

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.

Přehled studie

Detailní popis

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 >45, 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.

Typ studie

Intervenční

Zápis (Aktuální)

146

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Bursa, Turecko (Türkiye), 16310
        • Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 45 let (Dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Ženský

Popis

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 > 45 years. Age < 18 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: GDM Group (Experimental Arm)

This arm included 46 participants diagnosed with GDM following the 100-gram oral glucose tolerance test (OGTT) and meeting the Carpenter and Coustan diagnostic criteria for GDM. These participants showed higher levels of fasting glucose and C-reactive protein (CRP), and a higher hsCRP/albumin ratio compared to the control group. The study aimed to explore the relationship between the albumin/hsCRP ratio and GDM, along with the associated pregnancy complications and perinatal outcomes.

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.

Jiný: Control Group (Control Arm)

This arm consisted of 100 participants who had normal glucose tolerance, identified through the glucose challenge test (GCT) with results below 140 mg/dL, and did not meet the criteria for GDM on the OGTT. The control group was used for comparison to assess the differences in albumin/hsCRP ratios, glucose levels, and pregnancy outcomes between women without GDM and those diagnosed with GDM.

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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups
Časové okno: At the time of GDM diagnosis (during the 24-28 weeks of gestation) and at the end of the study.

This primary outcome measure assesses the difference in the albumin to hsCRP ratio between pregnant women diagnosed with gestational diabetes mellitus (GDM) and those in the control group with normal glucose tolerance. The albumin/hsCRP ratio is explored as a potential biomarker for GDM diagnosis and its relationship with pregnancy-related outcomes.

At the time of GDM diagnosis (during the 24-28 weeks of gestation) and at the end of the study.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Prevalence of Pregnancy Complications in Women with GDM vs. Control Group
Časové okno: During pregnancy and up to delivery (final pregnancy outcome assessment).

This outcome measure evaluates the occurrence of pregnancy complications, including threatened labor, preeclampsia, acute fetal distress, and other related conditions in women diagnosed with GDM compared to the control group.

During pregnancy and up to delivery (final pregnancy outcome assessment).
Gestational Age at Delivery in GDM vs. Control Group
Časové okno: At the time of delivery.

This outcome measure examines the difference in gestational age at delivery between the two groups. The study aims to assess whether GDM affects the timing of delivery.

At the time of delivery.
Birth Weight and Neonatal Outcomes in GDM vs. Control Group
Časové okno: At birth (within 24 hours after delivery).

This measure compares the birth weight, APGAR scores, and neonatal intensive care unit (NICU) admission rates between women diagnosed with GDM and the control group.

At birth (within 24 hours after delivery).
Change in Plasma Glucose Levels from GCT to OGTT in GDM and Control Groups
Časové okno: During the 24-28 weeks of gestation (at the time of GCT and OGTT).

This outcome measures the change in plasma glucose levels after the GCT and the subsequent 100-gram oral glucose tolerance test (OGTT) in both groups, assessing glucose tolerance and its relationship with GDM.

During the 24-28 weeks of gestation (at the time of GCT and OGTT).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Ali Bahadirli, M.D., Bursa City Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. února 2021

Primární dokončení (Aktuální)

3. února 2022

Dokončení studie (Aktuální)

3. července 2022

Termíny zápisu do studia

První předloženo

28. prosince 2024

První předloženo, které splnilo kritéria kontroly kvality

4. ledna 2025

První zveřejněno (Aktuální)

7. ledna 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. listopadu 2026

Naposledy ověřeno

1. ledna 2025

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

As per the facility's policy, individual participant data (IPD) will not be shared. The facility does not currently permit the sharing of such data for research purposes. We appreciate your understanding and respect for this policy.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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