Stimulated urine C‐peptide creatinine ratio vs serum C‐peptide level for monitoring of β‐cell function in the first year after diagnosis of Type 1 diabetes

Tatović, Danijela; Luzio, Stephen Denis; Dunseath, Gareth; Liu, YF; Ali, Mohammad Alhadj; Peakman, Mark; Dayan, Colin

doi:10.1111/dme.13186

Cited by 3 publications

(3 citation statements)

References 20 publications

(32 reference statements)

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“…Sensitive and reproducible assays for measuring C-peptide levels are highly accessible. 28 Further, HbA1c did not show any correlation with C-peptide levels in our study. Based on a review of recent studies evaluating new therapies for T1DM, the worldwide group of experts assembled by the American Diabetes Association concluded that evaluating beta-cell function via C-peptide level measurement is the most suitable primary outcome for crucial intervention studies of therapies aimed at preserving beta-cell function in patients with T1DM.…”

Section: Discussioncontrasting

confidence: 59%

Factors Associated with C-peptide Levels after Diagnosis in Children with Type 1 Diabetes Mellitus

2017

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C-peptide is the best indicator of endogenous insulin secretion in patients with diabetes. This study investigated the relationship between C-peptide levels and clinical/laboratory parameters of children with type 1 diabetes mellitus (T1DM), as measured at 6-month intervals after diagnosis. We retrospectively reviewed the data of 34 children with newly diagnosed T1DM. The study subjects were subdivided into a rapid progression group with C-peptide levels <0.6 ng/mL at 36 months (n=27; Group A) and a slow progression group with C-peptide levels >0.6 ng/mL at 36 months (n=7; Group B). Patients in Group A had a younger mean age at diagnosis (A: 9±4.3 years vs. B: 13.6±3.6 years; p=0.013) and lower body mass index (BMI) (A: 15.5±2.5 kg/m2 vs. B: 18.7±3.3 kg/m2; p=0.035). There were fewer asymptomatic patients with glucosuria in Group A, with these patients showing more severe symptoms, such as diabetic ketoacidosis (p=0.035), than those in Group B. Group A also had lower initial C-peptide levels (A: 0.5±0.46 ng/mL vs. B: 1.87±1.08 ng/mL; p=0.001). There were no significant intergroup differences in sex, family history, baseline hemoglobin A1c (HbA1c), potential of hydrogen (pH), autoantibodies or serum insulin. Simple correlation analyses showed that C-peptide levels were correlated with age and BMI, but not with pH, insulin, or HbA1c. Younger patients, who had a lower BMI, significant symptoms with complications, and/or a low initial C-peptide level, tended to show a rapid rate of decrease in C-peptide levels. Early intensive insulin therapy to preserve beta-cell function should be considered in these groups.

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Section: Discussioncontrasting

confidence: 59%

Factors Associated with C-peptide Levels after Diagnosis in Children with Type 1 Diabetes Mellitus

2017

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“…Ensure Plus® [Abbott Nutrition, Maidenhead, UK; 6 ml/kg (max 360 ml)] was used as a mixed-meal stimulant of β-cell production, in both the standard MMTT and the assessment of stimulated urine C-peptide/creatinine ratio as described previously [ 41 , 42 ]. MMTTs were carried out after an overnight fast at 0, 14, and 52 weeks.…”

Section: Methodsmentioning

confidence: 99%

Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes

Tatović

McAteer

Barry

et al. 2022

Immunotherapy Advances

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Antigen-specific immunotherapy is immunomodulatory strategy for autoimmune diseases, such as Type 1 diabetes, in which patients are treated with autoantigens to promote immune tolerance, stop autoimmune beta-cell destruction and prevent permanent dependence on exogenous insulin. In this study, human proinsulin peptide C19-A3 (known for its positive safety profile) was conjugated to ultrasmall gold nanoparticles (GNP), an attractive drug delivery platform due to the potential anti-inflammatory properties of gold. We hypothesised that microneedle intradermal delivery of C19-A3 GNP may improve peptide pharmacokinetics and induce tolerogenic immunomodulation and proceeded to evaluate its safety and feasibility in a first-in-human trial. Allowing for the limitation of the small number of participants, intradermal administration of C19-A3 GNP appears safe and well-tolerated in participants with Type 1 diabetes. The associated prolonged skin retention of C19-A3 GNP after intradermal administration offers a number of possibilities to enhance its tolerogenic potential, which should be explored in future studies.

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“…We selected this to determine whether it could be used as an alternative non-invasive test for future trials based on successes in other trials. 22 23 …”

Section: Methodsmentioning

confidence: 99%

Phase II multicentre, double-blind, randomised trial of ustekinumab in adolescents with new-onset type 1 diabetes (USTEK1D): trial protocol

et al. 2021

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IntroductionMost individuals newly diagnosed with type 1 diabetes (T1D) have 10%–20% of beta-cell function remaining at the time of diagnosis. Preservation of residual beta-cell function at diagnosis may improve glycaemic control and reduce longer-term complications.Immunotherapy has the potential to preserve endogenous beta-cell function and thereby improve metabolic control even in poorly compliant individuals. We propose to test ustekinumab (STELARA), a targeted and well-tolerated therapy that may halt T-cell and cytokine-mediated destruction of beta-cells in the pancreas at the time of diagnosis.Methods and analysisThis is a double-blind phase II study to assess the safety and efficacy of ustekinumab in 72 children and adolescents aged 12–18 with new-onset T1D.Participants should have evidence of residual functioning beta-cells (serum C-peptide level >0.2nmol/L in the mixed-meal tolerance test (MMTT) and be positive for at least one islet autoantibody (GAD, IA-2, ZnT8) to be eligible.Participants will be given ustekinumab/placebo subcutaneously at weeks 0, 4 and 12, 20, 28, 36 and 44 in a dose depending on the body weight and will be followed for 12 months after dose 1.MMTTs will be used to measure the efficacy of ustekinumab for preserving C-peptide area under the curve at week 52 compared with placebo. Secondary objectives include further investigations into the efficacy and safety of ustekinumab, patient and parent questionnaires, alternative methods for measuring insulin production and exploratory mechanistic work.Ethics and disseminationThis trial received research ethics approval from the Wales Research Ethics Committee 3 in September 2018 and began recruiting in December 2018.The results will be disseminated using highly accessed, peer-reviewed medical journals and presented at conferences.Trial registration numberISRCTN14274380.

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Stimulated urine C‐peptide creatinine ratio vs serum C‐peptide level for monitoring of β‐cell function in the first year after diagnosis of Type 1 diabetes

Cited by 3 publications

References 20 publications

Factors Associated with C-peptide Levels after Diagnosis in Children with Type 1 Diabetes Mellitus

Factors Associated with C-peptide Levels after Diagnosis in Children with Type 1 Diabetes Mellitus

Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes

Phase II multicentre, double-blind, randomised trial of ustekinumab in adolescents with new-onset type 1 diabetes (USTEK1D): trial protocol

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