Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type i diabetes: Lessons from the DIABGAD randomized pilot trial
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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.
|Research areas and keywords||
Subject classification (UKÄ) – MANDATORY
|Journal||Future science OA|
|Publication status||Published - 2020|