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  • 1
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    Online Resource
    Prevalence, Characteristics and Clinical Diagnosis of Maturity Onset Diabetes of the Young Due to Mutations in HNF1A, HNF4A, and Glucokinase: Results From the SEARCH for Diabetes in Youth
    The Endocrine Society ; 2013
    In:  The Journal of Clinical Endocrinology & Metabolism Vol. 98, No. 10 ( 2013-10), p. 4055-4062
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 98, No. 10 ( 2013-10), p. 4055-4062
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/jc.2013-1279
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2013
    detail.hit.zdb_id: 2026217-6
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  • 2
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    Barriers to Screening: An Analysis of Factors Impacting Screening for Type 1 Diabetes Prevention Trials
    The Endocrine Society ; 2023
    In:  Journal of the Endocrine Society Vol. 7, No. 3 ( 2023-01-06)
    Details
    In: Journal of the Endocrine Society, The Endocrine Society, Vol. 7, No. 3 ( 2023-01-06)
    Abstract: Participants with stage 1 or 2 type 1 diabetes (T1D) qualify for prevention trials, but factors involved in screening for such trials are largely unknown. Objective To identify factors associated with screening for T1D prevention trials. Methods This study included TrialNet Pathway to Prevention participants who were eligible for a prevention trial: oral insulin (TN-07, TN-20), teplizumab (TN-10), abatacept (TN-18), and oral hydroxychloroquine (TN-22). Univariate and multivariate logistic regression models were used to examine participant, site, and study factors at the time of prevention trial accrual. Results Screening rates for trials were: 50% for TN-07 (584 screened/1172 eligible), 9% for TN-10 (106/1249), 24% for TN-18 (313/1285), 17% for TN-20 (113/667), and 28% for TN-22 (371/1336). Younger age and male sex were associated with higher screening rates for prevention trials overall and for oral therapies. Participants with an offspring with T1D showed lower rates of screening for all trials and oral drug trials compared with participants with other first-degree relatives as probands. Site factors, including larger monitoring volume and US site vs international site, were associated with higher prevention trial screening rates. Conclusions Clear differences exist between participants who screen for prevention trials and those who do not screen and between the research sites involved in prevention trial screening. Participant age, sex, and relationship to proband are significantly associated with prevention trial screening in addition to key site factors. Identifying these factors can facilitate strategic recruitment planning to support rapid and successful enrollment into prevention trials.
    Type of Medium: Online Resource
    ISSN: 2472-1972
    URL: Article
    DOI: 10.1210/jendso/bvad003
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2023
    detail.hit.zdb_id: 2881023-5
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  • 3
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    Online Resource
    OGTT Metrics Surpass Continuous Glucose Monitoring Data for T1D Prediction in Multiple-Autoantibody–Positive Individuals
    The Endocrine Society ; 2023
    In:  The Journal of Clinical Endocrinology & Metabolism ( 2023-08-13)
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, ( 2023-08-13)
    Abstract: The value of continuous glucose monitoring (CGM) for monitoring autoantibody (AAB)-positive individuals in clinical trials for progression of type 1 diabetes (T1D) is unknown. Objective Compare CGM with oral glucose tolerance test (OGTT)–based metrics in prediction of T1D. Methods At academic centers, OGTT and CGM data from multiple-AAB relatives were evaluated for associations with T1D diagnosis. Participants were multiple-AAB–positive individuals in a TrialNet Pathway to Prevention (TN01) CGM ancillary study (n = 93). The intervention was CGM for 1 week at baseline, 6 months, and 12 months. Receiver operating characteristic (ROC) curves of CGM and OGTT metrics for prediction of T1D were analyzed. Results Five of 7 OGTT metrics and 29/48 CGM metrics but not HbA1c differed between those who subsequently did or did not develop T1D. ROC area under the curve (AUC) of individual CGM values ranged from 50% to 69% and increased when adjusted for age and AABs. However, the highest-ranking metrics were derived from OGTT: 4/7 with AUC ∼80%. Compared with adjusted multivariable models using CGM data, OGTT-derived variables, Index60 and DPTRS (Diabetes Prevention Trial-Type 1 Risk Score), had higher discriminative ability (higher ROC AUC and positive predictive value with similar negative predictive value). Conclusion Every 6-month CGM measures in multiple-AAB–positive individuals are predictive of subsequent T1D, but less so than OGTT-derived variables. CGM may have feasibility advantages and be useful in some settings. However, our data suggest there is insufficient evidence to replace OGTT measures with CGM in the context of clinical trials.
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/clinem/dgad472
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2023
    detail.hit.zdb_id: 2026217-6
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  • 4
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    Can Non-HLA Single Nucleotide Polymorphisms Help Stratify Risk in TrialNet Relatives at Risk for Type 1 Diabetes?
    The Endocrine Society ; 2017
    In:  The Journal of Clinical Endocrinology & Metabolism Vol. 102, No. 8 ( 2017-08-01), p. 2873-2880
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 102, No. 8 ( 2017-08-01), p. 2873-2880
    Abstract: Genome-wide association studies identified & gt;50 type 1 diabetes (T1D) associated non-human leukocyte antigens (non-HLA) loci. Objective The purpose of this study was to assess the contribution of non-HLA single nucleotide polymorphisms (SNPs) to risk of disease progression. Design and Setting The TrialNet Pathway to Prevention Study follows relatives of T1D patients for development of autoantibodies (Abs) and T1D. Participants Using the Immunochip, we analyzed 53 diabetes-associated, non-HLA SNPs in 1016 Ab-positive, at-risk non-Hispanic white relatives. Main Outcome Measure Effect of SNPs on the development of multiple Abs and T1D. Results Cox proportional analyses included all substantial non-HLA SNPs, HLA genotypes, relationship to proband, sex, age at initial screening, initial Ab type, and number. Factors involved in progression from single to multiple Abs included age at screening, relationship to proband, HLA genotypes, and rs3087243 (cytotoxic T lymphocyte antigen-4). Significant factors for diabetes progression included age at screening, Ab number, HLA genotypes, rs6476839 [GLIS family zinc finger 3 (GLIS3)], and rs3184504 [SH2B adaptor protein 3 (SH2B3)] . When glucose area under the curve (AUC) was included, factors involved in disease progression included glucose AUC, age at screening, Ab number, relationship to proband, HLA genotypes, rs6476839 (GLIS3), and rs7221109 (CCR7). In stratified analyses by age, glucose AUC, age at screening, sibling, HLA genotypes, rs6476839 (GLIS3), and rs4900384 (C14orf64) were significantly associated with progression to diabetes in participants & lt;12 years old, whereas glucose AUC, sibling, rs3184504 (SH2B3), and rs4900384 (C14orf64) were significant in those ≥12. Conclusions In conclusion, we identified five non-HLA SNPs associated with increased risk of progression from Ab positivity to disease that may improve risk stratification for prevention trials.
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/jc.2016-4003
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2017
    detail.hit.zdb_id: 2026217-6
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  • 5
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    Online Resource
    Lower Prevalence of Diabetic Ketoacidosis at Diagnosis in Research Participants Monitored for Hyperglycemia
    The Endocrine Society ; 2024
    In:  The Journal of Clinical Endocrinology & Metabolism ( 2024-03-12)
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, ( 2024-03-12)
    Abstract: In Colorado children, the prevalence of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes (T1D) has been increasing over time. Objective Evaluate the prevalence of and factors involved in DKA at T1D diagnosis among participants followed in monitoring research studies before diagnosis compared to patients from the community. Setting and Participants Patients  & lt; 18 years diagnosed with T1D between 2005 and 2021 at the Barbara Davis Center for Diabetes. Outcome Prevalence of and factors associated with DKA at diagnosis among participants in preclinical monitoring studies compared to those diagnosed in the community. Results Of 5049 subjects, 164 were active study participants, 42 inactive study participants, and 4843 were community patients. Active study participants, compared to community patients, had lower HbA1c (7.3% vs 11.9%]; P  & lt; 0.001) and less frequently experienced DKA (4.9% vs 48.5%; P  & lt; 0.001), including severe DKA (1.2% vs 16.2%; P  & lt; 0.001). Inactive study participants had intermediate levels for both prevalence and severity of DKA. DKA prevalence increased in community patients, from 44.0% to 55%, with less evidence for a temporal trend in study participants. DKA prevalence was highest in children & lt;2 years (13% in active study participants vs 83% in community patients). In community patients, younger age (P = 0.0038), public insurance (P  & lt; 0.0001), rural residence (P  & lt; 0.0076), higher HbA1c (P  & lt; 0.0001), and ethnicity minority status (P  & lt; 0.0001) were associated with DKA at diagnosis. Conclusions While DKA prevalence increases in community patients over time, it stayed & lt;5% in active research participants, who have a 10 times lower prevalence of DKA at diagnosis, including in minorities.
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/clinem/dgae158
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2024
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  • 6
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    Continuous Glucose Monitoring Profiles in Healthy, Nondiabetic Young Children
    The Endocrine Society ; 2022
    In:  Journal of the Endocrine Society Vol. 6, No. 6 ( 2022-06-01)
    Details
    In: Journal of the Endocrine Society, The Endocrine Society, Vol. 6, No. 6 ( 2022-06-01)
    Abstract: Continuous glucose monitoring (CGM) is increasingly being used both for day-to-day management in patients with diabetes and in clinical research. While data on glycemic profiles of healthy, nondiabetic individuals exist, data on nondiabetic very young children are lacking. Objective This work aimed to establish reference sensor glucose ranges in healthy, nondiabetic young children, using a current-generation CGM sensor. Methods This prospective observational study took place in an institutional practice with healthy, nondiabetic children aged 1 to 6 years with normal body mass index. A blinded Dexcom G6 Pro CGM was worn for approximately 10 days by each participant. Main outcome measures included CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. Results Thirty-nine participants were included in the analyses. Mean average glucose was 103 mg/dL (5.7 mmol/L). Median percentage time between 70 and 140 mg/dL (3.9-7.8 mmol/L) was 96% (interquartile range, 92%-97%), mean within-individual coefficient of variation was 17 ± 3%, median time spent with glucose levels greater than 140 mg/dL was 3.4% (49 min/day), and median time less than 70 mg/dL (3.9 mmol/L) was 0.4% (6 min/day). Conclusion Collecting normative sensor glucose data and describing glycemic measures for young children fill an important informational gap and will be useful as a benchmark for future clinical studies.
    Type of Medium: Online Resource
    ISSN: 2472-1972
    URL: Article
    DOI: 10.1210/jendso/bvac060
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2022
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  • 7
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    Online Resource
    The influence of pubertal development on autoantibody appearance and progression to type 1 diabetes in the TEDDY study
    The Endocrine Society ; 2024
    In:  Journal of the Endocrine Society
    Details
    In: Journal of the Endocrine Society, The Endocrine Society
    Abstract: The two peaks of type 1 diabetes incidence occur during early childhood and puberty. We sought to better understand the relationship between puberty, islet autoimmunity, and type 1 diabetes. Research design and methods The relationships between puberty, islet autoimmunity, and progression to type 1 diabetes were investigated prospectively in children followed in The Environmental Determinants of Diabetes in the Young (TEDDY) study. Onset of puberty was determined by subject self-assessment of Tanner Stages. Associations between speed of pubertal progression, pubertal growth, weight gain, HOMA-IR, islet autoimmunity, and progression to type 1 diabetes were assessed. The influence of individual factors was analyzed using Cox proportional hazard ratios. Results Out of 5,677 children who were still in the study at age 8 years, 95% reported at least one Tanner Stage score and were included in the study. Children at puberty (Tanner Stage ≥ 2) had a lower risk (HR, 0.65, 95% CI, 0.45-0.93; p = 0.019) for incident autoimmunity than prepubertal children (Tanner Stage 1). An increase of BMI Z-score was associated with a higher risk (HR, 2.88, 95% CI, 1.61-5.15; p & lt; 0.001) of incident insulin autoantibodies (mIAA). In children with multiple autoantibodies, neither HOMA-IR nor rate of progression to Tanner Stage 4 were associated with progression to type 1 diabetes. Conclusions Rapid weight gain during puberty is associated with development of islet autoimmunity. Puberty itself had no significant influence on the appearance of autoantibodies or type 1 diabetes. Further studies are needed to better understand the underlying mechanisms.
    Type of Medium: Online Resource
    ISSN: 2472-1972
    URL: Article
    DOI: 10.1210/jendso/bvae103
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2024
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  • 8
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    Advances in Type 1 Diabetes Prediction Using Islet Autoantibodies: Beyond a Simple Count
    The Endocrine Society ; 2021
    In:  Endocrine Reviews Vol. 42, No. 5 ( 2021-09-28), p. 584-604
    Details
    In: Endocrine Reviews, The Endocrine Society, Vol. 42, No. 5 ( 2021-09-28), p. 584-604
    Abstract: Islet autoantibodies are key markers for the diagnosis of type 1 diabetes. Since their discovery, they have also been recognized for their potential to identify at-risk individuals prior to symptoms. To date, risk prediction using autoantibodies has been based on autoantibody number; it has been robustly shown that nearly all multiple-autoantibody-positive individuals will progress to clinical disease. However, longitudinal studies have demonstrated that the rate of progression among multiple-autoantibody-positive individuals is highly heterogenous. Accurate prediction of the most rapidly progressing individuals is crucial for efficient and informative clinical trials and for identification of candidates most likely to benefit from disease modification. This is increasingly relevant with the recent success in delaying clinical disease in presymptomatic subjects using immunotherapy, and as the field moves toward population-based screening. There have been many studies investigating islet autoantibody characteristics for their predictive potential, beyond a simple categorical count. Predictive features that have emerged include molecular specifics, such as epitope targets and affinity; longitudinal patterns, such as changes in titer and autoantibody reversion; and sequence-dependent risk profiles specific to the autoantibody and the subject’s age. These insights are the outworking of decades of prospective cohort studies and international assay standardization efforts and will contribute to the granularity needed for more sensitive and specific preclinical staging. The aim of this review is to identify the dynamic and nuanced manifestations of autoantibodies in type 1 diabetes, and to highlight how these autoantibody features have the potential to improve study design of trials aiming to predict and prevent disease.
    Type of Medium: Online Resource
    ISSN: 0163-769X , 1945-7189
    URL: Article
    DOI: 10.1210/endrev/bnab013
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2021
    detail.hit.zdb_id: 2011701-2
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  • 9
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    Impact of Age and Antibody Type on Progression From Single to Multiple Autoantibodies in Type 1 Diabetes Relatives
    The Endocrine Society ; 2017
    In:  The Journal of Clinical Endocrinology & Metabolism Vol. 102, No. 8 ( 2017-08-01), p. 2881-2886
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 102, No. 8 ( 2017-08-01), p. 2881-2886
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/jc.2017-00569
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2017
    detail.hit.zdb_id: 2026217-6
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  • 10
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    Factors Associated With the Decline of C-Peptide in a Cohort of Young Children Diagnosed With Type 1 Diabetes
    The Endocrine Society ; 2021
    In:  The Journal of Clinical Endocrinology & Metabolism Vol. 106, No. 3 ( 2021-03-08), p. e1380-e1388
    Details
    In: The Journal of Clinical Endocrinology & Metabolism, The Endocrine Society, Vol. 106, No. 3 ( 2021-03-08), p. e1380-e1388
    Abstract: Understanding factors involved in the rate of C-peptide decline is needed to tailor therapies for type 1 diabetes (T1D). Objective Evaluate factors associated with rate of C-peptide decline after a T1D diagnosis in young children. Design Observational study. Setting Academic centers. Participants A total of 57 participants from the Environmental Determinants of Diabetes in the Young (TEDDY) study who were enrolled at 3 months of age and followed until T1D, and 56 age-matched children diagnosed with T1D in the community. Intervention A mixed meal tolerance test was used to measure the area under the curve (AUC) C-peptide at 1, 3, 6, 12, and 24 months postdiagnosis. Outcome Factors associated with rate of C-peptide decline during the first 2 years postdiagnosis were evaluated using mixed effects models, adjusting for age at diagnosis and baseline C-peptide. Results Adjusted slopes of AUC C-peptide decline did not differ between TEDDY subjects and community controls (P = 0.21), although the former had higher C-peptide baseline levels. In univariate analyses combining both groups (n = 113), younger age, higher weight and body mass index z-scores, female sex, an increased number increased number of islet autoantibodies, and IA-2A or ZnT8A positivity at baseline were associated with a higher rate of C-peptide loss. Younger age, female sex, and higher weight z-score remained significant in multivariate analysis (all P & lt; 0.02). At 3 months after diagnosis, higher HbA1c became an additional independent factor associated with a higher rate of C-peptide decline (P & lt; 0.01). Conclusion Younger age at diagnosis, female sex, higher weight z-score, and HbA1c were associated with a higher rate of C-peptide decline after T1D diagnosis in young children.
    Type of Medium: Online Resource
    ISSN: 0021-972X , 1945-7197
    URL: Article
    DOI: 10.1210/clinem/dgaa715
    RVK:
    XA 10000
    Language: English
    Publisher: The Endocrine Society
    Publication Date: 2021
    detail.hit.zdb_id: 2026217-6
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