scholarly journals Autologous Umbilical Cord Blood Infusion followed by Oral Docosahexaenoic Acid and Vitamin D Supplementation for C-Peptide Preservation in Children with Type 1 Diabetes

2013 ◽  
Vol 19 (7) ◽  
pp. 1126-1129 ◽  
Author(s):  
Michael J. Haller ◽  
Clive H. Wasserfall ◽  
Maigan A. Hulme ◽  
Miriam Cintron ◽  
Todd M. Brusko ◽  
...  
Keyword(s):  
Vitamin D ◽  
Type 1 Diabetes ◽  
Docosahexaenoic Acid ◽  
Cord Blood ◽  
Umbilical Cord ◽  
Umbilical Cord Blood ◽  
Vitamin D Supplementation ◽  
C Peptide

scholarly journals Autologous Umbilical Cord Blood Transfusion in Young Children With Type 1 Diabetes Fails to Preserve C-Peptide

Diabetes Care ◽  
2011 ◽  
Vol 34 (12) ◽  
pp. 2567-2569 ◽  
Author(s):  
M. J. Haller ◽  
C. H. Wasserfall ◽  
M. A. Hulme ◽  
M. Cintron ◽  
T. M. Brusko ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Transfusion ◽  
Young Children ◽  
Cord Blood ◽  
Umbilical Cord ◽  
Umbilical Cord Blood ◽  
C Peptide

scholarly journals Umbilical Cord Blood DNA Methylation in Children Who Later Develop Type 1 Diabetes

2021 ◽  
Author(s):  
Essi Laajala ◽  
Ubaid Ullah ◽  
Toni Grönroos ◽  
Omid Rasool ◽  
Viivi Halla-aho ◽  
...  
Keyword(s):  
Dna Methylation ◽  
Type 1 Diabetes ◽  
Cord Blood ◽  
Umbilical Cord ◽  
Umbilical Cord Blood ◽  
Reduced Representation ◽  
Prediction And Prevention ◽  
Develop Type ◽  
Methylation Patterns

Distinct DNA methylation patterns have recently been observed to precede type 1 diabetes in whole blood collected from young children. Our aim was to determine, whether perinatal DNA methylation could be associated with later progression to type 1 diabetes. Reduced representation bisulfite sequencing (RRBS) analysis was performed on umbilical cord blood samples collected within the Type 1 Diabetes Prediction and Prevention (DIPP) study. Children later diagnosed with type 1 diabetes and/or testing positive for multiple islet autoantibodies (N=43) were compared to control individuals (N=79), who remained autoantibody-negative throughout the DIPP follow-up until 15 years of age. Potential confounding factors related to the pregnancy and the mother were included in the analysis. No differences in the cord blood methylation patterns were observed between these cases and controls.

scholarly journals Autologous umbilical cord blood infusion for type 1 diabetes

2008 ◽  
Vol 36 (6) ◽  
pp. 710-715 ◽  
Author(s):  
Michael J. Haller ◽  
Hilla-Lee Viener ◽  
Clive Wasserfall ◽  
Todd Brusko ◽  
Mark A. Atkinson ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Cord Blood ◽  
Umbilical Cord ◽  
Umbilical Cord Blood

scholarly journals Autologous Umbilical Cord Blood Transfusion in Very Young Children With Type 1 Diabetes

Diabetes Care ◽  
2009 ◽  
Vol 32 (11) ◽  
pp. 2041-2046 ◽  
Author(s):  
M. J. Haller ◽  
C. H. Wasserfall ◽  
K. M. McGrail ◽  
M. Cintron ◽  
T. M. Brusko ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Blood Transfusion ◽  
Young Children ◽  
Cord Blood ◽  
Umbilical Cord ◽  
Umbilical Cord Blood ◽  
Very Young Children

scholarly journals Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial

2021 ◽  
Author(s):  
Johnny Ludvigsson ◽  
Zdenek Sumnik ◽  
Terezie Pelikanova ◽  
Lia Nattero Chavez ◽  
Elena Lundberg ◽  
...  
Keyword(s):  
Vitamin D ◽  
Type 1 Diabetes ◽  
Treatment Effect ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
C Peptide ◽  
Recent Onset ◽  
Hla Dr3 ◽  
Effect Ratio

<b>Objectives:</b> To evaluate the efficacy of intra-lymphatic GAD-alum therapy together with vitamin D supplementation on preserving endogenous insulin secretion in all patients with Type 1 diabetes (T1D) or in a genetically pre-specified subgroup. <p><b>Research Design and Methods:</b> In a multicenter, randomized, placebo-controlled double-blind trial (NCT03345004), 109 patients aged 12-24 (16.4 ± 4.1) years with a diabetes duration of 7-193 (88.8 ± 51.4) days, elevated serum GAD65 autoantibodies (GADA) and a fasting serum C-peptide >0.12 nmol/L, were recruited. Subjects were randomized to receive either three intra-lymphatic injections (one month apart) with 4 µg GAD-alum and oral vitamin D (2000 IE daily for 120 days), or placebo. The primary outcome was the change in stimulated serum C-peptide (mean area under the curve [AUC] after a mixed-meal tolerance test) between baseline and 15-month.</p> <p><b>Results:</b> </p> <p>Primary endpoint was not met in the full analysis set (treatment effect ratio 1.091, CI 0.845-1.408, p = 0.5009). However, GAD-alum treated patients carrying HLA DR3-DQ2 (n=29, defined as DRB1*03, DQB1*02:01) showed greater preservation of C-peptide AUC (treatment effect ratio 1.557, CI 1.126-2.153, p = 0.0078) after 15 months compared to placebo individuals with the same genotype (n=17). Several secondary end points showed supporting trends and a positive effect was seen in partial remission (IDAA1c≤9, p=0.0310). Minor transient injection site reactions were reported. </p> <p><b>Conclusions:</b> Intra-lymphatic administration of GAD-alum is a simple, well-tolerated treatment that together with vitamin D supplementation seems to preserve C-peptide in patients with recent onset T1D carrying HLA DR3-DQ2. This constitutes a disease modifying treatment for T1D with a precision medicine approach.</p>

scholarly journals Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial

2021 ◽  
Author(s):  
Johnny Ludvigsson ◽  
Zdenek Sumnik ◽  
Terezie Pelikanova ◽  
Lia Nattero Chavez ◽  
Elena Lundberg ◽  
...  
Keyword(s):  
Vitamin D ◽  
Type 1 Diabetes ◽  
Treatment Effect ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
C Peptide ◽  
Recent Onset ◽  
Hla Dr3 ◽  
Effect Ratio

<b>Objectives:</b> To evaluate the efficacy of intra-lymphatic GAD-alum therapy together with vitamin D supplementation on preserving endogenous insulin secretion in all patients with Type 1 diabetes (T1D) or in a genetically pre-specified subgroup. <p><b>Research Design and Methods:</b> In a multicenter, randomized, placebo-controlled double-blind trial (NCT03345004), 109 patients aged 12-24 (16.4 ± 4.1) years with a diabetes duration of 7-193 (88.8 ± 51.4) days, elevated serum GAD65 autoantibodies (GADA) and a fasting serum C-peptide >0.12 nmol/L, were recruited. Subjects were randomized to receive either three intra-lymphatic injections (one month apart) with 4 µg GAD-alum and oral vitamin D (2000 IE daily for 120 days), or placebo. The primary outcome was the change in stimulated serum C-peptide (mean area under the curve [AUC] after a mixed-meal tolerance test) between baseline and 15-month.</p> <p><b>Results:</b> </p> <p>Primary endpoint was not met in the full analysis set (treatment effect ratio 1.091, CI 0.845-1.408, p = 0.5009). However, GAD-alum treated patients carrying HLA DR3-DQ2 (n=29, defined as DRB1*03, DQB1*02:01) showed greater preservation of C-peptide AUC (treatment effect ratio 1.557, CI 1.126-2.153, p = 0.0078) after 15 months compared to placebo individuals with the same genotype (n=17). Several secondary end points showed supporting trends and a positive effect was seen in partial remission (IDAA1c≤9, p=0.0310). Minor transient injection site reactions were reported. </p> <p><b>Conclusions:</b> Intra-lymphatic administration of GAD-alum is a simple, well-tolerated treatment that together with vitamin D supplementation seems to preserve C-peptide in patients with recent onset T1D carrying HLA DR3-DQ2. This constitutes a disease modifying treatment for T1D with a precision medicine approach.</p>

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