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C-peptide and metab...
C-peptide and metabolic outcomes in trials of disease modifying therapy in new-onset type 1 diabetes: an individual participant meta-analysis
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- Taylor, Peter N (author)
- Department of Infection and Immunity, Cardiff University School of Medicine, Cardiff University, Cardiff, UK
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- Collins, Kimberly S (author)
- Critical Path Institute, Tucson, AZ, USA
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- Lam, Anna (author)
- Alberta Diabetes Institute, University of Alberta, Edmonton, AB, Canada
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- Karpen, Stephen R (author)
- Critical Path Institute, Tucson, AZ, USA
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- Greeno, Brianna (author)
- Critical Path Institute, Tucson, AZ, USA
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- Walker, Frank (author)
- Critical Path Institute, Tucson, AZ, USA
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- Lozano, Alejandro (author)
- Critical Path Institute, Tucson, AZ, USA
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- Atabakhsh, Elnaz (author)
- Critical Path Institute, Tucson, AZ, USA
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- Ahmed, Simi T (author)
- The New York Stem Cell Foundation Research Institute, New York, NY, USA
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- Marinac, Marjana (author)
- JDRF, New York, NY, USA
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- Latres, Esther (author)
- JDRF, New York, NY, USA
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- Senior, Peter A (author)
- Alberta Diabetes Institute, University of Alberta, Edmonton, AB, Canada
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- Rigby, Mark (author)
- Critical Path Institute, Tucson, AZ, USA
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- Gottlieb, Peter A (author)
- University of Colorado School of Medicine, Aurora, CO, USA
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- Dayan, Colin M (author)
- Department of Infection and Immunity, Cardiff University School of Medicine, Cardiff University, Cardiff, UK
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- Ludvigsson, Johnny, Professor, 1943- (contributor)
- Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus,Trial Outcome Markers Initiative collaboration
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(creator_code:org_t)
- Elsevier, 2023
- 2023
- English.
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In: The Lancet Diabetes and Endocrinology. - : Elsevier. - 2213-8587 .- 2213-8595. ; 11:12, s. 915-925
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Background: Metabolic outcomes in type 1 diabetes remain suboptimal. Disease modifying therapy to prevent β-cell loss presents an alternative treatment framework but the effect on metabolic outcomes is unclear. We, therefore, aimed to define the relationship between insulin C-peptide as a marker of β-cell function and metabolic outcomes in new-onset type 1 diabetes.Methods: 21 trials of disease-modifying interventions within 100 days of type 1 diabetes diagnosis comprising 1315 adults (ie, those 18 years and older) and 1396 children (ie, those younger than 18 years) were combined. Endpoints assessed were stimulated area under the curve C-peptide, HbA1c, insulin use, hypoglycaemic events, and composite scores (such as insulin dose adjusted A1c, total daily insulin, U/kg per day, and BETA-2 score). Positive studies were defined as those meeting their primary endpoint. Differences in outcomes between active and control groups were assessed using the Wilcoxon rank test.Findings: 6 months after treatment, a 24·8% greater C-peptide preservation in positive studies was associated with a 0·55% lower HbA1c (p<0·0001), with differences being detectable as early as 3 months. Cross-sectional analysis, combining positive and negative studies, was consistent with this proportionality: a 55% improvement in C-peptide preservation was associated with 0·64% lower HbA1c (p<0·0001). Higher initial C-peptide levels and greater preservation were associated with greater improvement in HbA1c. For HbA1c, IDAAC, and BETA-2 score, sample size predictions indicated that 2-3 times as many participants per group would be required to show a difference at 6 months as compared with C-peptide. Detecting a reduction in hypoglycaemia was affected by reporting methods.Interpretation: Interventions that preserve β-cell function are effective at improving metabolic outcomes in new-onset type 1 diabetes, confirming their potential as adjuncts to insulin. We have shown that improvements in HbA1c are directly proportional to the degree of C-peptide preservation, quantifying this relationship, and supporting the use of C-peptides as a surrogate endpoint in clinical trials.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
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- art (subject category)
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- By the author/editor
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Taylor, Peter N
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Collins, Kimberl ...
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Lam, Anna
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Karpen, Stephen ...
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Greeno, Brianna
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Walker, Frank
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Lozano, Alejandr ...
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Atabakhsh, Elnaz
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Ahmed, Simi T
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Marinac, Marjana
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Latres, Esther
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Senior, Peter A
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Rigby, Mark
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Gottlieb, Peter ...
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Dayan, Colin M
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Ludvigsson, John ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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The Lancet Diabe ...
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Linköping University