Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Kan albumin/C-reaktivt proteinforhold bruges til at forudsige graviditetsdiabetes diagnose eller de uønskede resultater (Alb/hsCRP)

30. oktober 2026 opdateret af: ALI BAHADIRLI, Mustafa Kemalpasa Government Hospital

Kan forholdet mellem albumin og højsensitivt C-reaktivt protein bruges til at forudsige graviditetsdiabetes mellitus-diagnose eller de uønskede resultater

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

146

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 35 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of Pregnancy Complications in Women with GDM vs. Control Group
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ali Bahadirli, M.D., Bursa City Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. februar 2021

Primær færdiggørelse (Faktiske)

3. februar 2022

Studieafslutning (Faktiske)

3. juli 2022

Datoer for studieregistrering

Først indsendt

28. december 2024

Først indsendt, der opfyldte QC-kriterier

4. januar 2025

Først opslået (Faktiske)

7. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. januar 2025

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner