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알부민/C 반응성 단백질 비율을 임신성 당뇨병 진단 또는 부작용 예측에 활용할 수 있습니까? (Alb/hsCRP)

2026년 11월 4일 업데이트: ALI BAHADIRLI, Mustafa Kemalpasa Government Hospital

알부민/고감도 C-반응성 단백질 비율을 임신성 당뇨병 진단 또는 부작용 예측에 활용할 수 있습니까?

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

146

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 특수 증상
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Prevalence of Pregnancy Complications in Women with GDM vs. Control Group
기간: 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
기간: 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
기간: 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
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Ali Bahadirli, M.D., Bursa City Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 2월 3일

기본 완료 (실제)

2022년 2월 3일

연구 완료 (실제)

2022년 7월 3일

연구 등록 날짜

최초 제출

2024년 12월 28일

QC 기준을 충족하는 최초 제출

2025년 1월 4일

처음 게시됨 (실제)

2025년 1월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2025년 1월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

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