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Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial

AIM: Double-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D). METHODS: 64 patients (T1D since <4 months, age 10–17.99, fasting sC-peptide ≥0.12 nmol/l, GADA-positive) were randomized into Day(D) 1–90...

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Autores principales: Ludvigsson, Johnny, Routray, Indusmita, Elluru, Sriramulu, Leanderson, Per, Larsson, Helena E, Rathsman, Björn, Hanås, Ragnar, Carlsson, Annelie, Ek, Torben, Samuelsson, Ulf, Torbjörnsdotter, Torun, Åman, Jan, Örtqvist, Eva, Badwal, Karun, Beam, Craig, Casas, Rosaura
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Future Science Ltd 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7421935/
https://www.ncbi.nlm.nih.gov/pubmed/32802401
http://dx.doi.org/10.2144/fsoa-2020-0078
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author Ludvigsson, Johnny
Routray, Indusmita
Elluru, Sriramulu
Leanderson, Per
Larsson, Helena E
Rathsman, Björn
Hanås, Ragnar
Carlsson, Annelie
Ek, Torben
Samuelsson, Ulf
Torbjörnsdotter, Torun
Åman, Jan
Örtqvist, Eva
Badwal, Karun
Beam, Craig
Casas, Rosaura
author_facet Ludvigsson, Johnny
Routray, Indusmita
Elluru, Sriramulu
Leanderson, Per
Larsson, Helena E
Rathsman, Björn
Hanås, Ragnar
Carlsson, Annelie
Ek, Torben
Samuelsson, Ulf
Torbjörnsdotter, Torun
Åman, Jan
Örtqvist, Eva
Badwal, Karun
Beam, Craig
Casas, Rosaura
author_sort Ludvigsson, Johnny
collection PubMed
description AIM: Double-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D). METHODS: 64 patients (T1D since <4 months, age 10–17.99, fasting sC-peptide ≥0.12 nmol/l, GADA-positive) were randomized into Day(D) 1–90 400 mg/day Ibuprofen, D1–450 vitamin D 2000 IU/day, D15, 45 sc. 20 μg GAD-alum; as A but placebo instead of Ibuprofen; as B but 40 μg GAD-alum D15, 45; placebo. RESULTS: Treatment was safe and tolerable. No C-peptide preservation was observed. We observed a linear correlation of baseline C-peptide, HbA1c and insulin/per kilogram/24 h with change in C-peptide AUC at 15 months (r = -0.776, p < 0.0001). CONCLUSION: Ibuprofen, vitamin D + GAD-alum did not preserve C-peptide. Treatment efficacy was influenced by baseline clinical and immunological factors and vitamin D concentration. Clinical Trial Registration: NCT01785108 (ClinicalTrials.gov).
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spelling pubmed-74219352020-08-14 Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial Ludvigsson, Johnny Routray, Indusmita Elluru, Sriramulu Leanderson, Per Larsson, Helena E Rathsman, Björn Hanås, Ragnar Carlsson, Annelie Ek, Torben Samuelsson, Ulf Torbjörnsdotter, Torun Åman, Jan Örtqvist, Eva Badwal, Karun Beam, Craig Casas, Rosaura Future Sci OA Research Article AIM: Double-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D). METHODS: 64 patients (T1D since <4 months, age 10–17.99, fasting sC-peptide ≥0.12 nmol/l, GADA-positive) were randomized into Day(D) 1–90 400 mg/day Ibuprofen, D1–450 vitamin D 2000 IU/day, D15, 45 sc. 20 μg GAD-alum; as A but placebo instead of Ibuprofen; as B but 40 μg GAD-alum D15, 45; placebo. RESULTS: Treatment was safe and tolerable. No C-peptide preservation was observed. We observed a linear correlation of baseline C-peptide, HbA1c and insulin/per kilogram/24 h with change in C-peptide AUC at 15 months (r = -0.776, p < 0.0001). CONCLUSION: Ibuprofen, vitamin D + GAD-alum did not preserve C-peptide. Treatment efficacy was influenced by baseline clinical and immunological factors and vitamin D concentration. Clinical Trial Registration: NCT01785108 (ClinicalTrials.gov). Future Science Ltd 2020-06-23 /pmc/articles/PMC7421935/ /pubmed/32802401 http://dx.doi.org/10.2144/fsoa-2020-0078 Text en © 2020 Johnny Ludvigsson This work is licensed under the Creative Commons Attribution 4.0 License (http://creativecommons.org/licenses/by/4.0/)
spellingShingle Research Article
Ludvigsson, Johnny
Routray, Indusmita
Elluru, Sriramulu
Leanderson, Per
Larsson, Helena E
Rathsman, Björn
Hanås, Ragnar
Carlsson, Annelie
Ek, Torben
Samuelsson, Ulf
Torbjörnsdotter, Torun
Åman, Jan
Örtqvist, Eva
Badwal, Karun
Beam, Craig
Casas, Rosaura
Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial
title Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial
title_full Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial
title_fullStr Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial
title_full_unstemmed Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial
title_short Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial
title_sort combined vitamin d, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset type i diabetes: lessons from the diabgad randomized pilot trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7421935/
https://www.ncbi.nlm.nih.gov/pubmed/32802401
http://dx.doi.org/10.2144/fsoa-2020-0078
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