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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

Ludvigsson, Johnny ; Routray, Indusmita ; Elluru, Sriramulu ; Leanderson, Per ; Larsson, Helena E. LU ; Rathsman, Björn ; Hanås, Ragnar ; Carlsson, Annelie LU orcid ; Ek, Torben and Samuelsson, Ulf , et al. (2020) In Future science OA 6(7).
Abstract

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 +... (More)

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). Lay abstract In many countries, Type I diabetes with insufficient own insulin secretion is a common life-threatening disease in children and adults. There is no prevention and no cure. In spite of very intense treatment, the disease leads to serious complications. There is no efficaceous method to save own insulin secretion without serious risks and adverse events, but autoantigen treatment with glutamic acid decarboxylase has shown some efficacy. We have tried a combination therapy with vitamin D and anti-inflammatory treatment (ibuprofen). Vitamin D in combination with glutamic acid decarboxylase-alum seems to have beneficial effects, but not Ibuprofen. The effect is influenced by basal clinical and immunological status.

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Contribution to journal
publication status
published
subject
keywords
C-peptide, GAD-alum, ibuprofen, immune response, Type I diabetes, vitamin D
in
Future science OA
volume
6
issue
7
article number
FSO604
publisher
Future Medicine Ltd.
external identifiers
  • scopus:85090165924
  • pmid:32802401
ISSN
2056-5623
DOI
10.2144/fsoa-2020-0078
language
English
LU publication?
yes
id
b9414ecf-3530-4046-bcdf-062a742135f2
date added to LUP
2020-09-25 15:47:48
date last changed
2023-03-24 05:14:49
@article{b9414ecf-3530-4046-bcdf-062a742135f2,
  abstract     = {{<p>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 &lt;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 &lt; 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). Lay abstract In many countries, Type I diabetes with insufficient own insulin secretion is a common life-threatening disease in children and adults. There is no prevention and no cure. In spite of very intense treatment, the disease leads to serious complications. There is no efficaceous method to save own insulin secretion without serious risks and adverse events, but autoantigen treatment with glutamic acid decarboxylase has shown some efficacy. We have tried a combination therapy with vitamin D and anti-inflammatory treatment (ibuprofen). Vitamin D in combination with glutamic acid decarboxylase-alum seems to have beneficial effects, but not Ibuprofen. The effect is influenced by basal clinical and immunological status. </p>}},
  author       = {{Ludvigsson, Johnny and Routray, Indusmita and Elluru, Sriramulu and Leanderson, Per and Larsson, Helena E. and Rathsman, Björn and Hanås, Ragnar and Carlsson, Annelie and Ek, Torben and Samuelsson, Ulf and Torbjörnsdotter, Torun and Åman, Jan and Örtqvist, Eva and Badwal, Karun and Beam, Craig and Casas, Rosaura}},
  issn         = {{2056-5623}},
  keywords     = {{C-peptide; GAD-alum; ibuprofen; immune response; Type I diabetes; vitamin D}},
  language     = {{eng}},
  number       = {{7}},
  publisher    = {{Future Medicine Ltd.}},
  series       = {{Future science OA}},
  title        = {{Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type i diabetes : Lessons from the DIABGAD randomized pilot trial}},
  url          = {{http://dx.doi.org/10.2144/fsoa-2020-0078}},
  doi          = {{10.2144/fsoa-2020-0078}},
  volume       = {{6}},
  year         = {{2020}},
}