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

NCT06761053 | Completed DMC

• 1 other identifier: 2011-KAEK-25
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

Gestational diabetes mellitus; Albumin; C-reactive protein; Pregnancy complications; Clinical marker

Outcome Measures

Primary Outcomes (1)

• Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups

  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.

Secondary Outcomes (4)

• Prevalence of Pregnancy Complications in Women with GDM vs. Control Group

  During pregnancy and up to delivery (final pregnancy outcome assessment).

• Gestational Age at Delivery in GDM vs. Control Group

  At the time of delivery.

• Birth Weight and Neonatal Outcomes in GDM vs. Control Group

  At birth (within 24 hours after delivery).

• Change in Plasma Glucose Levels from GCT to OGTT in GDM and Control Groups

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

Study Arms (2)

GDM Group (Experimental Arm)

EXPERIMENTAL

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.

Diagnostic Test: Intervention/Exposure for the GDM Group (Experimental Arm)

Control Group (Control Arm)

OTHER

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.

Diagnostic Test: Intervention/Exposure for the Control Group

Interventions

Intervention/Exposure for the GDM Group (Experimental Arm) DIAGNOSTIC_TEST

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.

GDM Group (Experimental Arm)

Intervention/Exposure for the Control Group DIAGNOSTIC_TEST

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.

Control Group (Control Arm)

Eligibility Criteria

• Age: Up to 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALI BAHADIRLI: lead
• Bursa Yuksek Ihtisas Training and Research Hospital: collaborator

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences

Bursa, 16310, Turkey (Türkiye)

Location

Related Publications (11)

• Eckart A, Struja T, Kutz A, Baumgartner A, Baumgartner T, Zurfluh S, Neeser O, Huber A, Stanga Z, Mueller B, Schuetz P. Relationship of Nutritional Status, Inflammation, and Serum Albumin Levels During Acute Illness: A Prospective Study. Am J Med. 2020 Jun;133(6):713-722.e7. doi: 10.1016/j.amjmed.2019.10.031. Epub 2019 Nov 18.

  PMID: 31751531 BACKGROUND

• Levitt DG, Levitt MD. Human serum albumin homeostasis: a new look at the roles of synthesis, catabolism, renal and gastrointestinal excretion, and the clinical value of serum albumin measurements. Int J Gen Med. 2016 Jul 15;9:229-55. doi: 10.2147/IJGM.S102819. eCollection 2016.

  PMID: 27486341 BACKGROUND

• Keenan-Devlin LS, Caplan M, Freedman A, Kuchta K, Grobman W, Buss C, Adam EK, Entringer S, Miller GE, Borders AEB. Using principal component analysis to examine associations of early pregnancy inflammatory biomarker profiles and adverse birth outcomes. Am J Reprod Immunol. 2021 Dec;86(6):e13497. doi: 10.1111/aji.13497. Epub 2021 Sep 19.

  PMID: 34477256 BACKGROUND

• Amirian A, Rahnemaei FA, Abdi F. Role of C-reactive Protein(CRP) or high-sensitivity CRP in predicting gestational diabetes Mellitus:Systematic review. Diabetes Metab Syndr. 2020 May-Jun;14(3):229-236. doi: 10.1016/j.dsx.2020.02.004. Epub 2020 Mar 16.

  PMID: 32247209 BACKGROUND

• Sifnaios E, Mastorakos G, Psarra K, Panagopoulos ND, Panoulis K, Vitoratos N, Rizos D, Creatsas G. Gestational Diabetes and T-cell (Th1/Th2/Th17/Treg) Immune Profile. In Vivo. 2019 Jan-Feb;33(1):31-40. doi: 10.21873/invivo.11435.

  PMID: 30587599 BACKGROUND

• Liu W, Huang Z, Tang S, Zhang Z, Yu Q, He J. Changes of Serum Sex Hormone-Binding Globulin, Homocysteine, and Hypersensitive CRP Levels during Pregnancy and Their Relationship with Gestational Diabetes Mellitus. Gynecol Obstet Invest. 2021;86(1-2):193-199. doi: 10.1159/000515085. Epub 2021 Apr 27.

  PMID: 33906193 BACKGROUND

• Bo S, Signorile A, Menato G, Gambino R, Bardelli C, Gallo ML, Cassader M, Massobrio M, Pagano GF. C-reactive protein and tumor necrosis factor-alpha in gestational hyperglycemia. J Endocrinol Invest. 2005 Oct;28(9):779-86. doi: 10.1007/BF03347566.

  PMID: 16370555 BACKGROUND

• Maged AM, Moety GA, Mostafa WA, Hamed DA. Comparative study between different biomarkers for early prediction of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2014 Jul;27(11):1108-12. doi: 10.3109/14767058.2013.850489. Epub 2013 Oct 22.

  PMID: 24090161 BACKGROUND

• Eades CE, Cameron DM, Evans JMM. Prevalence of gestational diabetes mellitus in Europe: A meta-analysis. Diabetes Res Clin Pract. 2017 Jul;129:173-181. doi: 10.1016/j.diabres.2017.03.030. Epub 2017 May 9.

  PMID: 28531829 BACKGROUND

• Saeedi M, Cao Y, Fadl H, Gustafson H, Simmons D. Increasing prevalence of gestational diabetes mellitus when implementing the IADPSG criteria: A systematic review and meta-analysis. Diabetes Res Clin Pract. 2021 Feb;172:108642. doi: 10.1016/j.diabres.2020.108642. Epub 2021 Jan 13.

  PMID: 33359574 BACKGROUND

• Sharma AK, Singh S, Singh H, Mahajan D, Kolli P, Mandadapu G, Kumar B, Kumar D, Kumar S, Jena MK. Deep Insight of the Pathophysiology of Gestational Diabetes Mellitus. Cells. 2022 Aug 28;11(17):2672. doi: 10.3390/cells11172672.

  PMID: 36078079 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ali Bahadirli, M.D.

  Bursa City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 7, 2025
• Study Start: February 3, 2021
• Primary Completion: February 3, 2022
• Study Completion: July 3, 2022
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)