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  • 1
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    A Type 1 Diabetes Genetic Risk Score Predicts Progression of Islet Autoimmunity and Development of Type 1 Diabetes in Individuals at Risk
    American Diabetes Association ; 2018
    In:  Diabetes Care Vol. 41, No. 9 ( 2018-09-01), p. 1887-1894
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 41, No. 9 ( 2018-09-01), p. 1887-1894
    Abstract: We tested the ability of a type 1 diabetes (T1D) genetic risk score (GRS) to predict progression of islet autoimmunity and T1D in at-risk individuals. RESEARCH DESIGN AND METHODS We studied the 1,244 TrialNet Pathway to Prevention study participants (T1D patients’ relatives without diabetes and with one or more positive autoantibodies) who were genotyped with Illumina ImmunoChip (median [range] age at initial autoantibody determination 11.1 years [1.2–51.8], 48% male, 80.5% non-Hispanic white, median follow-up 5.4 years). Of 291 participants with a single positive autoantibody at screening, 157 converted to multiple autoantibody positivity and 55 developed diabetes. Of 953 participants with multiple positive autoantibodies at screening, 419 developed diabetes. We calculated the T1D GRS from 30 T1D-associated single nucleotide polymorphisms. We used multivariable Cox regression models, time-dependent receiver operating characteristic curves, and area under the curve (AUC) measures to evaluate prognostic utility of T1D GRS, age, sex, Diabetes Prevention Trial–Type 1 (DPT-1) Risk Score, positive autoantibody number or type, HLA DR3/DR4-DQ8 status, and race/ethnicity. We used recursive partitioning analyses to identify cut points in continuous variables. RESULTS Higher T1D GRS significantly increased the rate of progression to T1D adjusting for DPT-1 Risk Score, age, number of positive autoantibodies, sex, and ethnicity (hazard ratio [HR] 1.29 for a 0.05 increase, 95% CI 1.06–1.6; P = 0.011). Progression to T1D was best predicted by a combined model with GRS, number of positive autoantibodies, DPT-1 Risk Score, and age (7-year time-integrated AUC = 0.79, 5-year AUC = 0.73). Higher GRS was significantly associated with increased progression rate from single to multiple positive autoantibodies after adjusting for age, autoantibody type, ethnicity, and sex (HR 2.27 for GRS & gt;0.295, 95% CI 1.47–3.51; P = 0.0002). CONCLUSIONS The T1D GRS independently predicts progression to T1D and improves prediction along T1D stages in autoantibody-positive relatives.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc18-0087
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 2
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    Time to Peak Glucose and Peak C-Peptide During the Progression to Type 1 Diabetes in the Diabetes Prevention Trial and TrialNet Cohorts
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 10 ( 2021-10-01), p. 2329-2336
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 10 ( 2021-10-01), p. 2329-2336
    Abstract: To assess the progression of type 1 diabetes using time to peak glucose or C-peptide during oral glucose tolerance tests (OGTTs) in autoantibody-positive relatives of people with type 1 diabetes. RESEARCH DESIGN AND METHODS We examined 2-h OGTTs of participants in the Diabetes Prevention Trial Type 1 (DPT-1) and TrialNet Pathway to Prevention (PTP) studies. We included 706 DPT-1 participants (mean ± SD age, 13.84 ± 9.53 years; BMI Z-score, 0.33 ± 1.07; 56.1% male) and 3,720 PTP participants (age, 16.01 ± 12.33 years; BMI Z-score, 0.66 ± 1.3; 49.7% male). Log-rank testing and Cox regression analyses with adjustments (age, sex, race, BMI Z-score, HOMA-insulin resistance, and peak glucose/C-peptide levels, respectively) were performed. RESULTS In each of DPT-1 and PTP, higher 5-year diabetes progression risk was seen in those with time to peak glucose & gt;30 min and time to peak C-peptide & gt;60 min (P & lt; 0.001 for all groups), before and after adjustments. In models examining strength of association with diabetes development, associations were greater for time to peak C-peptide versus peak C-peptide value (DPT-1: χ2 = 25.76 vs. χ2 = 8.62; PTP: χ2 = 149.19 vs. χ2 = 79.98; all P & lt; 0.001). Changes in the percentage of individuals with delayed glucose and/or C-peptide peaks were noted over time. CONCLUSIONS In two independent at-risk populations, we show that those with delayed OGTT peak times for glucose or C-peptide are at higher risk of diabetes development within 5 years, independent of peak levels. Moreover, time to peak C-peptide appears more predictive than the peak level, suggesting its potential use as a specific biomarker for diabetes progression.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc21-0226
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 3
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    300-OR: Stage Transitions in Preclinical Type 1 Diabetes—Protective Effect of IA2 Variant Autoantibody Positivity
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: We previously demonstrated that the IA2 variant (IA2var) autoantibody (AA) is associated with enhanced prediction of type 1 diabetes (T1D) in at-risk individuals but its effect on progression through preclinical T1D stages is unknown. We aimed to assess the influence of IA2var AA on rates and risks of transitions from Stage 1 (multiple AA positive, no dysglycemia) to Stage 2 (multiple AA positive, dysglycemia) and to Stage 3 (clinical T1D). Participants in the Diabetes Prevention Trial (DPT-1) with Stage 1 or Stage 2 T1D at baseline and having ≥2 glucose tolerance tests during follow-up were selected (N=175). Standard AA (GAD65, ICA, ICA512 and insulin AA) were considered as biomarkers in addition to IA2var. Data analysis used Markov transition models. The estimated 12-month probability of transition from Stage 1 to 3 (N=89) was 13.8% (95% CI: 9.7%, 18.8%) and from Stage 2 to 3 (N=86) it was 41.3% (30.6%, 52.6%). IA2var AA, sex, age and were statistically significant risk factors for the Stage 2 to 3 transition (Table 1, B). Importantly, IA2var AA (the only significantly influential AA) was associated with a reduction in the risk of transition from Stage 2 to 3. In sum, male sex, older age and positive IA2var AA significantly decreased the risk of transition from Stage 2 to Stage 3 T1D. This information has important implications for the selection of candidates for T1D prevention in clinical and research practices. Disclosure C.Beam: None. S.Pietropaolo: None. M.J.Acevedo-calado: None. M.A.Herman: Research Support; Eli Lilly and Company. M.J.Redondo: None. M.Pietropaolo: None. Funding National Institutes of Health (2R01DK053456-19A1); Robert and Janice McNair Foundation
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-300-OR
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 4
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    The Rare and Atypical Diabetes Network (RADIANT) Study: Design and Early Results
    American Diabetes Association ; 2023
    In:  Diabetes Care Vol. 46, No. 6 ( 2023-06-01), p. 1265-1270
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 46, No. 6 ( 2023-06-01), p. 1265-1270
    Abstract: The Rare and Atypical Diabetes Network (RADIANT) will perform a study of individuals and, if deemed informative, a study of their family members with uncharacterized forms of diabetes. RESEARCH DESIGN AND METHODS The protocol includes genomic (whole-genome [WGS], RNA, and mitochondrial sequencing), phenotypic (vital signs, biometric measurements, questionnaires, and photography), metabolomics, and metabolic assessments. RESULTS Among 122 with WGS results of 878 enrolled individuals, a likely pathogenic variant in a known diabetes monogenic gene was found in 3 (2.5%), and six new monogenic variants have been identified in the SMAD5, PTPMT1, INS, NFKB1, IGF1R, and PAX6 genes. Frequent phenotypic clusters are lean type 2 diabetes, autoantibody-negative and insulin-deficient diabetes, lipodystrophic diabetes, and new forms of possible monogenic or oligogenic diabetes. CONCLUSIONS The analyses will lead to improved means of atypical diabetes identification. Genetic sequencing can identify new variants, and metabolomics and transcriptomics analysis can identify novel mechanisms and biomarkers for atypical disease.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc22-2440
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 5
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    Association of Non-HLA Genes With Type 1 Diabetes Autoimmunity
    American Diabetes Association ; 2005
    In:  Diabetes Vol. 54, No. 8 ( 2005-08-01), p. 2482-2486
    Details
    In: Diabetes, American Diabetes Association, Vol. 54, No. 8 ( 2005-08-01), p. 2482-2486
    Abstract: Approximately 50% of the genetic risk for type 1 diabetes is attributable to the HLA region. We evaluated associations between candidate genes outside the HLA region–INS, cytotoxic T-lymphocyte–associated antigen (CTLA)-4, interleukin (IL)-4, IL-4R, and IL-13 and islet autoimmunity among children participating in the Diabetes Autoimmunity Study in the Young (DAISY). Children with persistent islet autoantibody positivity (n = 102, 38 of whom have already developed diabetes) and control subjects (n = 198) were genotyped for single nucleotide polymorphisms (SNPs) in the candidate genes. The INS-23Hph1 polymorphism was significantly associated with both type 1 diabetes (OR = 0.30; 95% CI 0.13–0.69) and persistent islet autoimmunity but in the latter, only in children with the HLA-DR3/4 genotype (0.40; 0.18–0.89). CTLA-4 promoter SNP was significantly associated with type 1 diabetes (3.52; 1.22–10.17) but not with persistent islet autoimmunity. Several SNPs in the IL-4 regulatory pathway appeared to have a predisposing effect for type 1 diabetes. Associations were found between both IL-4R haplotypes and IL-4–IL-13 haplotypes and persistent islet autoimmunity and type 1 diabetes. This study confirms the association between the INS and CTLA-4 loci and type 1 diabetes. Genes involved in the IL-4 regulatory pathway (IL-4, IL-4R, IL-13) may confer susceptibility or protection to type 1 diabetes depending on individual SNPs or specific haplotypes.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/diabetes.54.8.2482
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2005
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  • 6
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    Introducing the Endotype Concept to Address the Challenge of Disease Heterogeneity in Type 1 Diabetes
    American Diabetes Association ; 2020
    In:  Diabetes Care Vol. 43, No. 1 ( 2020-01-01), p. 5-12
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 1 ( 2020-01-01), p. 5-12
    Abstract: The clinical diagnosis of new-onset type 1 diabetes has, for many years, been considered relatively straightforward. Recently, however, there is increasing awareness that within this single clinical phenotype exists considerable heterogeneity: disease onset spans the complete age range; genetic susceptibility is complex; rates of progression differ markedly, as does insulin secretory capacity; and complication rates, glycemic control, and therapeutic intervention efficacy vary widely. Mechanistic and immunopathological studies typically show considerable patchiness across subjects, undermining conclusions regarding disease pathways. Without better understanding, type 1 diabetes heterogeneity represents a major barrier both to deciphering pathogenesis and to the translational effort of designing, conducting, and interpreting clinical trials of disease-modifying agents. This realization comes during a period of unprecedented change in clinical medicine, with increasing emphasis on greater individualization and precision. For complex disorders such as type 1 diabetes, the option of maintaining the “single disease” approach appears untenable, as does the notion of individualizing each single patient’s care, obliging us to conceptualize type 1 diabetes less in terms of phenotypes (observable characteristics) and more in terms of disease endotypes (underlying biological mechanisms). Here, we provide our view on an approach to dissect heterogeneity in type 1 diabetes. Using lessons from other diseases and the data gathered to date, we aim to delineate a roadmap through which the field can incorporate the endotype concept into laboratory and clinical practice. We predict that such an effort will accelerate the implementation of precision medicine and has the potential for impact on our approach to translational research, trial design, and clinical management.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-0880
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 7
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    Individuals with Single Islet Autoantibody Positivity (SA+) at Type 1 Diabetes (T1D) Diagnosis Have Distinct Characteristics
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: Multiple autoantibody positivity (MA+) usually precedes clinical T1D. However, a subset of patients who develop T1D have SA+. We hypothesized that individuals who at T1D diagnosis express SA+ compared with MA+ have different demographic, metabolic, immunologic and genetic characteristics. We studied 620 TrialNet participants who developed clinical T1D (median age=12.3 years [range=1.4-58.6], 47.5% male, 88% white). Using multivariable modeling and adjusting for potential confounders, we investigated differences between participants with SA+ vs. MA+ (of autoantibodies to GAD65 [GADA] , insulin [mIAA], IA2, ZnT8 and ICA) at T1D diagnosis. We found 95 participants who had SA+ (70% GADA+) and 525 participants with MA+. In univariate analyses, individuals with SA+ vs. MA+ were older at T1D diagnosis (median 16.4 vs. 11.7 years, p & lt;0.0001) and had higher fasting C-peptide (1.87 vs. 1.47 nmol/L, p=0.007), higher 30-0 minute C-peptide difference (1.42 vs. 1.18, p=0.009) and lower Index60 (composite measure of fasting C-peptide, 60-min glucose and 60-min C-peptide) (2.31 vs. 2.68, p=0.0005). Gender, race, ethnicity, BMI-Z-score, presence of HLA DR3-DQ2 and/or DR4-DQ8, fasting glucose, AUC glucose and AUC C-peptide were not significantly different. By multivariable analyses, SA+ at onset corresponded with older age (OR=1.05, p & lt;0.0001), lower Index60 (OR=0.77, p=0.008), and lower likelihood of mIAA+ (OR=0.27, p & lt;0.0001) and GADA+ (OR=0.25, p & lt;0.0001); gender, HLA, BMI-Z-score and other autoantibody types were not significantly different. Independent factors of being SA+ differed between DR3/DR4-DQ8 heterozygous participants (older age and not having mIAA+ or GADA+) (p & lt;0.01) and those not DR3/DR4-DQ8 (lower Index60 and not having GADA+) (p & lt;0.01). In conclusion, the number of islet autoantibodies at T1D diagnosis is associated with distinct characteristics, which may suggest heterogeneous pathogenesis with relevance for T1D prevention and treatment. Disclosure M.J. Redondo: None. J. Sosenko: None. I. Libman: Consultant; Self; Novo Nordisk A/S. J.J. McVean: Speaker's Bureau; Self; Medtronic MiniMed, Inc. M.A. Atkinson: Other Relationship; Self; Patent Issued. D.J. Becker: None. S. Geyer: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1691-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 8
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    Depressive Symptoms in Youth With Type 1 or Type 2 Diabetes: Results of the Pediatric Diabetes Consortium Screening Assessment of Depression in Diabetes Study
    American Diabetes Association ; 2015
    In:  Diabetes Care Vol. 38, No. 12 ( 2015-12-01), p. 2341-2343
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 38, No. 12 ( 2015-12-01), p. 2341-2343
    Abstract: To evaluate the frequency of depressive symptoms and the diagnosis and management of depression in youth with type 1 diabetes (T1D) and type 2 diabetes (T2D) enrolled in the Pediatric Diabetes Consortium T1D and T2D registries. RESEARCH DESIGN AND METHODS The Children’s Depression Inventory (CDI) 2 Self-Report (Short) version was completed by 261 T1D and 339 T2D youth aged 10–17 years. RESULTS Symptoms of depression were identified in 13% of T1D and 22% of T2D (P = 0.007) participants; of these, only 4% of T1D and 9% of T2D youth were treated by a therapist within the prior 12 months. Depressive symptoms were associated with lower family income (P = 0.006) and obesity (P = 0.002) in T1D but not T2D youth. CONCLUSIONS Depressive symptoms are more frequent than diagnosed depression in youth with T1D or T2D. These results underscore the need for regular depression screening and appropriate referral for youth with diabetes.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc15-0982
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2015
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  • 9
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    348-OR: Metabolic Phenotype of Autoantibody Positive (AbPos) Long-Term Nonprogressors (LTNPs) to Type 1 Diabetes (T1D)
    American Diabetes Association ; 2020
    In:  Diabetes Vol. 69, No. Supplement_1 ( 2020-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 69, No. Supplement_1 ( 2020-06-01)
    Abstract: Few studies have described the metabolic phenotype of AbPos individuals who remain T1D free for an extended period of time. We aimed to compare C-peptide and glucose (Glu) data from oral glucose tolerance tests (OGTTs) performed longitudinally in 646 AbPos TrialNet Pathway to Prevention (PTP) participants who remained T1D free for ≥5.0 yrs (LTNPs; mean follow-up: 7.8±2.3 yrs) versus 405 Rapid Progressor (RP) PTP participants who progressed to T1D within & lt;2 yrs of study entry (mean follow-up 0.97±0.54 yrs) and 150 Ab negative (AbNeg) controls. At study entry, 48% of LTNPs were single AbPos and 52% were multiple AbPos; 45.8% of single AbPos LTNPs became multiple AbPos during follow-up. LTNPs were older (mean age 18.8 ± 14.1 yrs) compared to RPs (11.8 ± 9.3 yrs) and AbNeg individuals (16 ± 10 yrs) (p & lt;0.001). LTNPS exhibited an intermediate metabolic phenotype, with age and BMIZ-adjusted C-peptide area under the curve (AUC) and 30-0 min C-peptide values that were lower than AbNegs but higher than RPs (p & lt;0.001), and Index60 levels (a composite of glucose and C-peptide values from OGTTs) that were higher than AbNegs but lower than RPs (p & lt;0.001). Longitudinal trends in LTNPs were analyzed using fitted linear mixed models. Multiple AbPos LTNPs had higher Glu AUC (p=0.01) and Index60 values (p=0.032) compared to single AbPos LTNPs. However within both AbPos groups, metabolic patterns were remarkably stable over extended follow-up. When measures were evaluated for non-linear interactions using a regression tree analysis, the combination of Index60 & lt;1.06 + Glu AUC & lt;137.7 at baseline was associated with an odds ratio of 8.55 (p & lt;0.001) of being a LTNP. These data suggest that, while β cell function is reduced in LTNPs at the time of AbPos identification, longitudinal Glu and C-peptide patterns are largely stable without evidence of a relapsing or remitting course. Baseline OGTT measures (here, Index 60 and Glu AUC) may be able to predict AbPos individuals with lower risk of progression to T1D. Disclosure C. Evans-Molina: Consultant; Self; Bristol-Myers Squibb. Z.I. Saeed: None. J. Sosenko: None. M.A. Atkinson: None. K.C. Herold: Consultant; Self; Provention Bio, Inc. H.M. Ismail: None. H. Elding Larsson: None. M. Lundgren: None. A. Moran: Research Support; Self; Abbott, Intrexon, JDRF, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Provention Bio, Inc. Other Relationship; Self; Novo Nordisk Inc. D.J. Moore: None. B.M. Nathan: None. J.P. Palmer: None. E.K. Sims: None. A. Steck: None. D.K. Wherrett: None. M.J. Redondo: None. Funding National Institutes of Health (U01107014, U01DK106993)
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db20-348-OR
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 10
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    Early and Later C-Peptide Responses during Oral Glucose Tolerance Testing (OGTT) Are Independently and Oppositely Predictive of Type 1 Diabetes (T1D) in Autoantibody-Positive (Ab+) Individuals
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: A longitudinal study showed that early C-peptide (C-P) responsiveness during OGTTs declined during progression to T1D, whereas later C-P responsiveness increased until the diagnosis was imminent. Here we exmaine: 1) whether the baseline C-P response pattern predicts T1D as suggested by the findings from that longitudinal study, and 2) the basis for the higher later C-peptide response during progression. Baseline 2-hour OGTTs from 670 Diabetes Prevention Trial-type 1 participants (age: 13.8±9.6 years; BMI-z: 0.3±1.1; 56% male) were analyzed. In univariate regression models, the early C-P response (30-0 min) was inversely predictive of T1D (X2=28.8, p & lt;0.001), whereas the later C-P response (120-60 min) was positively predictive (X2= 23.3, p & lt;0.001). Each was at least as predictive as the AUC C-peptide (inverse association; X2 = 20.4; p & lt;0.001), a standard prediction measure. In a model including both early and late C-P responses, both remained oppositely predictive of T1D with a stronger overall association (X2=41.1; p & lt;0.001 for both). To explain the positive association of greater T1D risk with a high later C-P, we examined the association between the sum of glucose levels from 60 to 120 min and the 120-60 min C-P; there was a strong positive association (r=0.44, p & lt;0.001). All associations persisted after age and BMI-z adjustments. In conclusion, the findings show that lower early and higher later C-P responses are both indicators of risk for progression to T1D. Moreover, the findings suggest that the increasing later C-P response reflects an attempt by the β-cell to compensate for higher glucose levels due to a deficient early C-P response. These findings are similar to the evolution of C-P responses during type 2 diabetes development. Partitioning C-peptide into early and later responses appears beneficial for T1D prediction and for studying β-cell deterioration during progression. Disclosure H.M. Ismail: None. D.J. Becker: None. S. Geyer: None. P. Xu: None. I. Libman: Consultant; Self; Novo Nordisk A/S. K.C. Herold: None. M.A. Atkinson: Other Relationship; Self; Patent Issued. M.J. Redondo: None. J.P. Palmer: None. J. Sosenko: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1374-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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