Gestational Diabetes Mellitus in PregnancyAlb/hsCRPNCT06761053
Can Albumin/C-reactive Protein Ratio be Utilized for Predicting Gestational Diabetes Diagnosis or the Adverse Outcomes
A study testing Intervention/Exposure for the GDM Group (Experimental Arm) in people with Gestational Diabetes Mellitus in Pregnancy, run by Mustafa Kemalpasa Government Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Intervention/Exposure for the GDM Group (Experimental Arm)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2021to 3 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Pre-gestational diabetes mellitus.
- BMI > 30.
- Age > 35 years.
- A history of gestational diabetes mellitus (GDM).
- Previous delivery of macrosomic infants.
- Unexplained fetal loss.
Show all 9Show fewer
- Family history of type II diabetes mellitus.
- Any endocrinological disease.
- Liver disease, renal disease, or other significant systemic or local infections.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital, University of Health Sciences
Bursa, 16310
About this study
Official title: Can the Albumin/High Sensitive C-reactive Protein Ratio be Utilized for Predicting Gestational Diabetes Mellitus Diagnosis or the Adverse Outcomes
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.
Read the 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 >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.
- Being tested
- Intervention/Exposure for the GDM Group (Experimental Arm), Intervention/Exposure for the Control Group
- Keywords
- Gestational diabetes mellitus, Albumin, C-reactive protein, Pregnancy complications, Clinical marker
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Intervention/Exposure for the Control GroupDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Intervention/Exposure for the Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: During pregnancy and up to delivery (final pregnancy outcome assessment).
Gestational Age at Delivery in GDM vs. Control Group
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.
Measured: At the time of delivery.
Birth Weight and Neonatal Outcomes in GDM vs. Control Group
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.
Measured: At birth (within 24 hours after delivery).
Change in Plasma Glucose Levels from GCT to OGTT in GDM and Control Groups
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.
Measured: During the 24-28 weeks of gestation (at the time of GCT and OGTT).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start3 Feb 2021
- Primary completion3 Feb 2022
- Study completion3 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemalpasa Government Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Responsible party
- Principal investigator, ALI BAHADIRLI, Bursa City Hospital
- Investigators
- Ali Bahadirli, M.D., Principal investigator, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761053
- Sponsor's protocol ID
- 2011-KAEK-25
- Acronym
- Alb/hsCRP
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31751531Levitt 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.
PubMed 27486341Keenan-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.
PubMed 34477256Amirian 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.
PubMed 32247209Sifnaios 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.
PubMed 30587599Liu 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.
PubMed 33906193Bo 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.
PubMed 16370555Maged 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.
PubMed 24090161Eades 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.
PubMed 28531829Saeedi 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.
PubMed 33359574Sharma 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.
PubMed 36078079
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Albumin/High Sensitive C-reactive Protein Ratio be Utilized for Predicting Gestational Diabetes Mellitus Diagnosis or the Adverse Outcomes
- ClinicalTrials.gov ID
- NCT06761053
- Acronym / sponsor ID
- Alb/hsCRP / 2011-KAEK-25
- Keywords
- Gestational diabetes mellitus, Albumin, C-reactive protein, Pregnancy complications, Clinical marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Mustafa Kemalpasa Government HospitalUniversity, hospital or other
- Collaborators
- Bursa Yuksek Ihtisas Training and Research Hospital
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Jul 2022 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 >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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| GDM Group (Experimental Arm) | Experimental | Diagnostic Test: Intervention/Exposure for the 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. |
| Control Group (Control Arm) | Other | Diagnostic Test: Intervention/Exposure for the Control GroupThis 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. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Pre-gestational diabetes mellitus.
- BMI > 30.
- Age > 35 years.
- A history of gestational diabetes mellitus (GDM).
- Previous delivery of macrosomic infants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention/Exposure for the GDM Group (Experimental Arm)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. | Diagnostic test | GDM Group (Experimental Arm) |
| Intervention/Exposure for the Control GroupGlucose 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. | Diagnostic test | Control Group (Control Arm) |
Primary outcome
Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups
Time frame: 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.
4 secondary outcomes
Prevalence of Pregnancy Complications in Women with GDM vs. Control Group
Time frame: During pregnancy and up to delivery (final pregnancy outcome assessment).
Gestational Age at Delivery in GDM vs. Control Group
Time frame: At the time of delivery.
Birth Weight and Neonatal Outcomes in GDM vs. Control Group
Time frame: At birth (within 24 hours after delivery).
Change in Plasma Glucose Levels from GCT to OGTT in GDM and Control Groups
Time frame: During the 24-28 weeks of gestation (at the time of GCT and OGTT).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 31751531Eckart 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.
- Background: PubMed 27486341Levitt 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.
- Background: PubMed 34477256Keenan-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.
- Background: PubMed 32247209Amirian 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.
- Background: PubMed 30587599Sifnaios 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.
- Background: PubMed 33906193Liu 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.
- Background: PubMed 16370555Bo 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.
- Background: PubMed 24090161Maged 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.
- Background: PubMed 28531829Eades 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.
- Background: PubMed 33359574Saeedi 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.
- Background: PubMed 36078079Sharma 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Bahadirli, M.D. principal investigator
Bursa City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention/Exposure for the GDM Group (Experimental Arm) in people with Gestational Diabetes Mellitus in Pregnancy, run by Mustafa Kemalpasa Government Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Albumin to High-Sensitivity C-Reactive Protein (hsCRP) Ratio Between GDM and Control Groups (time frame: At the time of GDM diagnosis (during the 24-28 weeks of gestation) and at the end of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761053, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.