TY - JOUR
T1 - Cohort profile
T2 - the 'Biomarkers of heterogeneity in type 1 diabetes' study-a national prospective cohort study of clinical and metabolic phenotyping of individuals with long-standing type 1 diabetes in the Netherlands
AU - Dutch Type 1 Diabetes Biomarker group
AU - Aanstoot, Henk-Jan
AU - Varkevisser, Rita D M
AU - Mul, Dick
AU - Dekker, Pim
AU - Birnie, Erwin
AU - Boesten, Lianne S M
AU - Brugts, Michael P
AU - van Dijk, Peter R
AU - Duijvestijn, Petronella H L M
AU - Dutta, Sanjoy
AU - Fransman, Christine
AU - Gonera, Rob K
AU - Hoogenberg, Klaas
AU - Kooy, Adriaan
AU - Latres, Esther
AU - Loves, Sandra
AU - Nefs, Giesje
AU - Sas, Theo
AU - Vollenbrock, Charlotte E
AU - Vosjan-Noeverman, Marleen J
AU - de Vries-Velraeds, Martine M C
AU - Veeze, Henk J
AU - Wolffenbuttel, Bruce H R
AU - van der Klauw, Melanie M
N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/6/19
Y1 - 2024/6/19
N2 - PURPOSE: The 'Biomarkers of heterogeneity in type 1 diabetes' study cohort was set up to identify genetic, physiological and psychosocial factors explaining the observed heterogeneity in disease progression and the development of complications in people with long-standing type 1 diabetes (T1D).PARTICIPANTS: Data and samples were collected in two subsets. A prospective cohort of 611 participants aged ≥16 years with ≥5 years T1D duration from four Dutch Diabetes clinics between 2016 and 2021 (median age 32 years; median diabetes duration 12 years; 59% female; mean glycated haemoglobin (HbA1c) 61 mmol/mol (7.7%); 61% on insulin pump; 23% on continuous glucose monitoring (CGM)). Physical assessments were performed, blood and urine samples were collected, and participants completed questionnaires. A subgroup of participants underwent mixed-meal tolerance tests (MMTTs) at baseline (n=169) and at 1-year follow-up (n=104). Genetic data and linkage to medical and administrative records were also available. A second cross-sectional cohort included participants with ≥35 years of T1D duration (currently n=160; median age 64 years; median diabetes duration 45 years; 45% female; mean HbA1c 58 mmol/mol (7.4%); 51% on insulin pump; 83% on CGM), recruited from five centres and measurements, samples and 5-year retrospective data were collected.FINDINGS TO DATE: Stimulated residual C-peptide was detectable in an additional 10% of individuals compared with fasting residual C-peptide secretion. MMTT measurements at 90 min and 120 min showed good concordance with the MMTT total area under the curve. An overall decrease of C-peptide at 1-year follow-up was observed. Fasting residual C-peptide secretion is associated with a decreased risk of impaired awareness of hypoglycaemia.FUTURE PLANS: Research groups are invited to consider the use of these data and the sample collection. Future work will include additional hormones, beta-cell-directed autoimmunity, specific immune markers, microRNAs, metabolomics and gene expression data, combined with glucometrics, anthropometric and clinical data, and additional markers of residual beta-cell function.TRIAL REGISTRATION NUMBER: NCT04977635.
AB - PURPOSE: The 'Biomarkers of heterogeneity in type 1 diabetes' study cohort was set up to identify genetic, physiological and psychosocial factors explaining the observed heterogeneity in disease progression and the development of complications in people with long-standing type 1 diabetes (T1D).PARTICIPANTS: Data and samples were collected in two subsets. A prospective cohort of 611 participants aged ≥16 years with ≥5 years T1D duration from four Dutch Diabetes clinics between 2016 and 2021 (median age 32 years; median diabetes duration 12 years; 59% female; mean glycated haemoglobin (HbA1c) 61 mmol/mol (7.7%); 61% on insulin pump; 23% on continuous glucose monitoring (CGM)). Physical assessments were performed, blood and urine samples were collected, and participants completed questionnaires. A subgroup of participants underwent mixed-meal tolerance tests (MMTTs) at baseline (n=169) and at 1-year follow-up (n=104). Genetic data and linkage to medical and administrative records were also available. A second cross-sectional cohort included participants with ≥35 years of T1D duration (currently n=160; median age 64 years; median diabetes duration 45 years; 45% female; mean HbA1c 58 mmol/mol (7.4%); 51% on insulin pump; 83% on CGM), recruited from five centres and measurements, samples and 5-year retrospective data were collected.FINDINGS TO DATE: Stimulated residual C-peptide was detectable in an additional 10% of individuals compared with fasting residual C-peptide secretion. MMTT measurements at 90 min and 120 min showed good concordance with the MMTT total area under the curve. An overall decrease of C-peptide at 1-year follow-up was observed. Fasting residual C-peptide secretion is associated with a decreased risk of impaired awareness of hypoglycaemia.FUTURE PLANS: Research groups are invited to consider the use of these data and the sample collection. Future work will include additional hormones, beta-cell-directed autoimmunity, specific immune markers, microRNAs, metabolomics and gene expression data, combined with glucometrics, anthropometric and clinical data, and additional markers of residual beta-cell function.TRIAL REGISTRATION NUMBER: NCT04977635.
KW - Humans
KW - Female
KW - Diabetes Mellitus, Type 1/metabolism
KW - Male
KW - Netherlands
KW - Adult
KW - Prospective Studies
KW - Middle Aged
KW - Glycated Hemoglobin/analysis
KW - Biomarkers/blood
KW - Cross-Sectional Studies
KW - Phenotype
KW - Blood Glucose/metabolism
KW - Young Adult
KW - Disease Progression
KW - C-Peptide/blood
KW - Aged
KW - Adolescent
U2 - 10.1136/bmjopen-2023-082453
DO - 10.1136/bmjopen-2023-082453
M3 - Article
C2 - 38904129
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e082453
ER -