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Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study

Gareth Dunseath Orcid Logo, Michael Atkinson, Ivy Cheung, Steve Luzio Orcid Logo, Rajesh Peter

BMJ Open, Volume: 15, Issue: 9, Start page: e100039

Swansea University Authors: Gareth Dunseath Orcid Logo, Ivy Cheung, Steve Luzio Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2025-100039

Abstract

Introduction: Gestational diabetes mellitus (GDM) is common in pregnancy and is increasing in prevalence. It is associated with an increased risk of maternal and perinatal complications if not diagnosed and managed early. Most guidelines suggest making a diagnosis of GDM using an oral glucose tolera...

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Published in: BMJ Open
ISSN: 2044-6055
Published: BMJ Publishing Group Ltd 2025
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It is associated with an increased risk of maternal and perinatal complications if not diagnosed and managed early. Most guidelines suggest making a diagnosis of GDM using an oral glucose tolerance test (OGTT) between 24 and 28 weeks of pregnancy at which stage there still is an increased risk of complications. Increased beta-cell secretory product concentrations have been observed prior to changes in glycaemia and can potentially be used as an early marker to diagnose and assess risk of developing GDM. Methods: The study was a prospective, longitudinal cohort study. OGTTs were carried out at visit one: 16&#x2013;18 weeks and visit two: 24&#x2013;28&#x2009;weeks gestation in pregnant women with at least one risk factor for GDM [Body Mass Index &gt;30&#x2009;kg/m2, previous macrosomic baby (&gt;4.5&#x2009;kg), previous GDM, first degree relative with type 2 diabetes mellitus (T2DM)]. Blood sampling was performed at fasting, 30&#x2009;min, 1 and 2&#x2009;hours following a 75-g oral glucose load. Samples were analysed for glucose, total and intact proinsulin, insulin and C-peptide. Hormonal concentrations at visit 1 were compared between those that remained normal glucose tolerant (NGT) and those that progressed to GDM at visit 2 using receiver operator characteristic (ROC) area under the curve (AUC) to assess for discrimination between the two groups. Results: Unfortunately, a smaller than planned sample size was recruited due to the start of COVID-19 pandemic midway through the study. 83 pregnant women had OGTT at visit 1. Of these, 12 reached the threshold for GDM at visit 1 and were excluded. In total, data from 66 patients were included for analysis (5 Did Not Attend). Visit 1 hormone comparisons were carried out between 51 who remained NGT and 15 who progressed to GDM at visit 2. There were no significant differences at each time point in ROC AUC between the two groups for total and intact proinsulin and insulin. However, there were significant differences observed in C-peptide ROC AUC at 30 (p=0.041) and 60&#x2009;min (p=0.003) between the two groups. Conclusions: This study did not demonstrate significant increase in early proinsulin concentrations in patients that developed GDM. However, there were differences in C-peptide concentrations. The COVID-19 pandemic restricted the recruitment of patient numbers and further studies in a larger cohort will be needed to validate these findings. 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spelling 2025-10-07T15:41:00.3987368 v2 70209 2025-08-21 Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study fccbba9edcaee08a839a3c5cff8cbe19 0000-0001-6022-862X Gareth Dunseath Gareth Dunseath true false a9142ffd398f89eff40ada503e315639 Ivy Cheung Ivy Cheung true false 01491e1cd582746a654fad9addf0de16 0000-0002-7206-6530 Steve Luzio Steve Luzio true false 2025-08-21 MEDS Introduction: Gestational diabetes mellitus (GDM) is common in pregnancy and is increasing in prevalence. It is associated with an increased risk of maternal and perinatal complications if not diagnosed and managed early. Most guidelines suggest making a diagnosis of GDM using an oral glucose tolerance test (OGTT) between 24 and 28 weeks of pregnancy at which stage there still is an increased risk of complications. Increased beta-cell secretory product concentrations have been observed prior to changes in glycaemia and can potentially be used as an early marker to diagnose and assess risk of developing GDM. Methods: The study was a prospective, longitudinal cohort study. OGTTs were carried out at visit one: 16–18 weeks and visit two: 24–28 weeks gestation in pregnant women with at least one risk factor for GDM [Body Mass Index >30 kg/m2, previous macrosomic baby (>4.5 kg), previous GDM, first degree relative with type 2 diabetes mellitus (T2DM)]. Blood sampling was performed at fasting, 30 min, 1 and 2 hours following a 75-g oral glucose load. Samples were analysed for glucose, total and intact proinsulin, insulin and C-peptide. Hormonal concentrations at visit 1 were compared between those that remained normal glucose tolerant (NGT) and those that progressed to GDM at visit 2 using receiver operator characteristic (ROC) area under the curve (AUC) to assess for discrimination between the two groups. Results: Unfortunately, a smaller than planned sample size was recruited due to the start of COVID-19 pandemic midway through the study. 83 pregnant women had OGTT at visit 1. Of these, 12 reached the threshold for GDM at visit 1 and were excluded. In total, data from 66 patients were included for analysis (5 Did Not Attend). Visit 1 hormone comparisons were carried out between 51 who remained NGT and 15 who progressed to GDM at visit 2. There were no significant differences at each time point in ROC AUC between the two groups for total and intact proinsulin and insulin. However, there were significant differences observed in C-peptide ROC AUC at 30 (p=0.041) and 60 min (p=0.003) between the two groups. Conclusions: This study did not demonstrate significant increase in early proinsulin concentrations in patients that developed GDM. However, there were differences in C-peptide concentrations. The COVID-19 pandemic restricted the recruitment of patient numbers and further studies in a larger cohort will be needed to validate these findings. Trial registration number ISRCTN16416602. Journal Article BMJ Open 15 9 e100039 BMJ Publishing Group Ltd 2044-6055 5 9 2025 2025-09-05 10.1136/bmjopen-2025-100039 COLLEGE NANME Medical School COLLEGE CODE MEDS Swansea University SU Library paid the OA fee (TA Institutional Deal) This work was supported by a Pathway to Portfolio Grant from Abertawe Bro Morgannwg University Health Board (now Swansea Bay University Health Board). 2025-10-07T15:41:00.3987368 2025-08-21T12:18:50.7694503 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Biomedical Science Gareth Dunseath 0000-0001-6022-862X 1 Michael Atkinson 2 Ivy Cheung 3 Steve Luzio 0000-0002-7206-6530 4 Rajesh Peter 5 70209__35277__80a371b07ab348f69a26969f08f5927d.pdf 70209.VOR.pdf 2025-10-07T15:38:11.4986381 Output 1081408 application/pdf Version of Record true © Author(s) (or their employer(s)) 2025. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license. true eng https://creativecommons.org/licenses/by/4.0/
title Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
spellingShingle Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
Gareth Dunseath
Ivy Cheung
Steve Luzio
title_short Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
title_full Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
title_fullStr Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
title_full_unstemmed Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
title_sort Pancreatic beta-cell secretory products in the diagnosis and risk stratification of gestational diabetes mellitus: a prospective longitudinal cohort study
author_id_str_mv fccbba9edcaee08a839a3c5cff8cbe19
a9142ffd398f89eff40ada503e315639
01491e1cd582746a654fad9addf0de16
author_id_fullname_str_mv fccbba9edcaee08a839a3c5cff8cbe19_***_Gareth Dunseath
a9142ffd398f89eff40ada503e315639_***_Ivy Cheung
01491e1cd582746a654fad9addf0de16_***_Steve Luzio
author Gareth Dunseath
Ivy Cheung
Steve Luzio
author2 Gareth Dunseath
Michael Atkinson
Ivy Cheung
Steve Luzio
Rajesh Peter
format Journal article
container_title BMJ Open
container_volume 15
container_issue 9
container_start_page e100039
publishDate 2025
institution Swansea University
issn 2044-6055
doi_str_mv 10.1136/bmjopen-2025-100039
publisher BMJ Publishing Group Ltd
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Biomedical Science{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Biomedical Science
document_store_str 1
active_str 0
description Introduction: Gestational diabetes mellitus (GDM) is common in pregnancy and is increasing in prevalence. It is associated with an increased risk of maternal and perinatal complications if not diagnosed and managed early. Most guidelines suggest making a diagnosis of GDM using an oral glucose tolerance test (OGTT) between 24 and 28 weeks of pregnancy at which stage there still is an increased risk of complications. Increased beta-cell secretory product concentrations have been observed prior to changes in glycaemia and can potentially be used as an early marker to diagnose and assess risk of developing GDM. Methods: The study was a prospective, longitudinal cohort study. OGTTs were carried out at visit one: 16–18 weeks and visit two: 24–28 weeks gestation in pregnant women with at least one risk factor for GDM [Body Mass Index >30 kg/m2, previous macrosomic baby (>4.5 kg), previous GDM, first degree relative with type 2 diabetes mellitus (T2DM)]. Blood sampling was performed at fasting, 30 min, 1 and 2 hours following a 75-g oral glucose load. Samples were analysed for glucose, total and intact proinsulin, insulin and C-peptide. Hormonal concentrations at visit 1 were compared between those that remained normal glucose tolerant (NGT) and those that progressed to GDM at visit 2 using receiver operator characteristic (ROC) area under the curve (AUC) to assess for discrimination between the two groups. Results: Unfortunately, a smaller than planned sample size was recruited due to the start of COVID-19 pandemic midway through the study. 83 pregnant women had OGTT at visit 1. Of these, 12 reached the threshold for GDM at visit 1 and were excluded. In total, data from 66 patients were included for analysis (5 Did Not Attend). Visit 1 hormone comparisons were carried out between 51 who remained NGT and 15 who progressed to GDM at visit 2. There were no significant differences at each time point in ROC AUC between the two groups for total and intact proinsulin and insulin. However, there were significant differences observed in C-peptide ROC AUC at 30 (p=0.041) and 60 min (p=0.003) between the two groups. Conclusions: This study did not demonstrate significant increase in early proinsulin concentrations in patients that developed GDM. However, there were differences in C-peptide concentrations. The COVID-19 pandemic restricted the recruitment of patient numbers and further studies in a larger cohort will be needed to validate these findings. Trial registration number ISRCTN16416602.
published_date 2025-09-05T05:30:16Z
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