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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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Future Science Ltd
2020
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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). |
format | Online Article Text |
id | pubmed-7421935 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Future Science Ltd |
record_format | MEDLINE/PubMed |
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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