Evidence map›Paper›PMID 32802401›Full record

ArticleFuture science OA2020

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

Johnny Ludvigsson, Indusmita Routray, Sriramulu Elluru, Per Leanderson, Helena E Larsson, Björn Rathsman, Ragnar Hanås, Annelie Carlsson, Torben Ek, Ulf Samuelsson and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Future science OA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01785108 (Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01785108 phase2completednot on this map

Pilot Trial to Preserve Residual Insulin Secretion in Children and Adolescents With Recent Onset Type 1 Diabetes by Using GAD-antigen (Diamyd) Therapy in Combination With Vitamin D and Ibuprofen

TypeinterventionalSponsorJohnny LudvigssonRan2013 to 2017Enrolled60ConditionsDiabetes Mellitus, Type 1ArmsGAD-Alum (Diamyd) 20 µg, GAD-Alum (Diamyd) 20 µg X 2, Vitamin D, Ibuprofen
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 2 countries.

Johnny LudvigssonDepartment of Biomedical & Clinical Sciences, Crown Princess Victoria Children´s Hospital & Div of Pediatrics, Linköping University, SE-58185, Linköping, Sweden.ORCID https://orcid.org/0000-0003-1695-5234
Indusmita RoutrayDepartment of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.ORCID https://orcid.org/0000-0002-0910-7141
Sriramulu ElluruDepartment of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.ORCID https://orcid.org/0000-0001-9188-710X
Per LeandersonDepartment of Clinical & Experimental Medicine, Occupational & Environmental Medicine Center, Linköping University, Linköping S-58185, Sweden.
Helena E LarssonPediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Sweden & Department of Pediatrics, Skåne University Hospital, SE-21428 Malmö, Sweden.ORCID https://orcid.org/0000-0003-3306-1742
Björn RathsmanSachska Pediatric Hospital, Södersjukhuset, SE-11861 Stockholm, Sweden.ORCID https://orcid.org/0000-0003-0941-1351
Ragnar HanåsDepartment of Pediatrics, NU Hospital Group, SE 45153 Uddevalla, Sweden & Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, SE 41346 Gothenburg, Sweden.ORCID https://orcid.org/0000-0001-8372-030X
Annelie CarlssonPediatric Autoimmunity, Department of Clinical Sciences Lund, Lund University, Sweden, Skåne University Hospital, SE-22242 Lund, Sweden.ORCID https://orcid.org/0000-0002-5608-3437
Torben EkDepartment of Pediatrics, Hospital of Halland, SE 30233 Halmstad, Sweden.ORCID https://orcid.org/0000-0002-0518-983X
Ulf SamuelssonDepartment of Biomedical & Clinical Sciences, Crown Princess Victoria Children´s Hospital & Div of Pediatrics, Linköping University, SE-58185, Linköping, Sweden.ORCID https://orcid.org/0000-0002-2837-4237
Torun TorbjörnsdotterDepartment of Women & Child Health, Astrid Lindgrens Children's Hospital at Karolinska University Hospital, Karolinska Institutet, SE 17164 Stockholm, Sweden.
Jan ÅmanDepartment of Pediatrics, University Hospital, SE 70382 Örebro, Sweden.
Eva ÖrtqvistDepartment of Women & Child Health, Astrid Lindgren Children's Hospital at Karolinska University Hospital, Karolinska Institutet, SE 17164 Stockholm, Sweden.ORCID https://orcid.org/0000-0002-6924-704X
Karun BadwalDepartment of Internal Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.ORCID https://orcid.org/0000-0002-5090-8434
Craig BeamDepartment of Biomedical Sciences, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.ORCID https://orcid.org/0000-0002-8772-7661
Rosaura CasasDepartment of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.ORCID https://orcid.org/0000-0002-7414-6104
Linköping University · SEKarolinska University Hospital · SELund University · SEWestern Michigan University · USHallands sjukhus Halmstad · SENU Hospital Group · SEÖrebro University Hospital · SEStockholm South General Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimDouble-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D).

methods64 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.

resultsTreatment 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).

conclusionIbuprofen, 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).

Indexed as

C-peptideGAD-alumibuprofenimmune responseType I diabetesvitamin D

Identifiers

PMID32802401
PMCPMC7421935
OpenAlexW3036106596

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.