SwePub
Sök i LIBRIS databas

  Extended search

onr:"swepub:oai:gup.ub.gu.se/307550"
 

Search: onr:"swepub:oai:gup.ub.gu.se/307550" > Intralymphatic Glut...

  • 1 of 1
  • Previous record
  • Next record
  •    To hitlist
  • Ludvigsson, JohnnyLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus (author)

Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-05-21
  • American Diabetes Association,2021

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/307550
  • https://gup.ub.gu.se/publication/307550URI
  • https://doi.org/10.2337/dc21-0318DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-108583URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-187334URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-178444URI

Supplementary language notes

  • Language:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Funding Agency:Diamyd Medical
  • Funding Agencies|Barndiabetesfonden (Swedish Child Diabetes Foundation); Diabetesfonden; Diamyd Medical
  • OBJECTIVE To evaluate the efficacy of aluminum-formulated intralymphatic glutamic acid decarboxylase (GAD-alum) therapy combined with vitamin D supplementation in preserving endogenous insulin secretion in all patients with type 1 diabetes (T1D) or in a genetically prespecified subgroup. RESEARCH DESIGN AND METHODS In a multicenter, randomized, placebo-controlled, double-blind trial, 109 patients aged 12-24 years (mean +/- SD 16.4 +/- 4.1) with a diabetes duration of 7-193 days (88.8 +/- 51.4), elevated serum GAD65 autoantibodies, and a fasting serum C-peptide >0.12 nmol/L were recruited. Participants were randomized to receive either three intralymphatic injections (1 month apart) with 4 mu g GAD-alum and oral vitamin D (2,000 IE daily for 120 days) or placebo. The primary outcome was the change in stimulated serum C-peptide (mean area under the curve [AUC] after a mixed-meal tolerance test) between baseline and 15 months. RESULTS Primary end point was not met in the full analysis set (treatment effect ratio 1.091 [CI 0.845-1.408]; P = 0.5009). However, GAD-alum-treated patients carrying HLA DR3-DQ2 (n = 29; defined as DRB1*03, DQB1*02:01) showed greater preservation of C-peptide AUC (treatment effect ratio 1.557 [CI 1.126-2.153]; P = 0.0078) after 15 months compared with individuals receiving placebo with the same genotype (n = 17). Several secondary end points showed supporting trends, and a positive effect was seen in partial remission (insulin dose-adjusted HbA(1c) <= 9; P = 0.0310). Minor transient injection site reactions were reported. CONCLUSION Intralymphatic administration of GAD-alum is a simple, well-tolerated treatment that together with vitamin D supplementation seems to preserve C-peptide in patients with recent-onset T1D carrying HLA DR3-DQ2. This constitutes a disease-modifying treatment for T1D with a precision medicine approach.

Subject headings and genre

Added entries (persons, corporate bodies, meetings, titles ...)

  • Sumnik, Z.Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic,Charles Univ Prague, Czech Republic (author)
  • Pelikanova, T.Diabetes Centre of the Institute of Clinical and Experimental Medicine, Prague, Czech Republic,Inst Clin & Expt Med, Czech Republic (author)
  • Chavez, L. N.Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Madrid, Spain,Hosp Univ Ramon & Cajal, Spain (author)
  • Lundberg, Elena,1961-Umeå universitet,Pediatrik,Umea Univ, Sweden(Swepub:umu)ellu0034 (author)
  • Rica, I.Department of Pediatric Endocrinology, Cruces University Hospital, CIBERDEM, Bilbao, Spain,Cruces Univ Hosp, Spain (author)
  • Martinez-Brocca, M. A.Department of Endocrinology, Virgen Macarena Hospital, Sevilla, Spain,Virgen Macarena Hosp, Spain (author)
  • de Adana, M. R.Department of Adult Endocrinology and Diabetology, General University Hospital, Instituto de Biomedicina de Málaga, CIBERDEM, Malaga, Spain,Gen Univ Hosp, Spain (author)
  • Wahlberg, Jeanette,1969-Linköpings universitet,Örebro universitet,Institutionen för medicinska vetenskaper,Departments of Endocrinology Region Östergötland and Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden,Medicinska fakulteten,Avdelningen för diagnostik och specialistmedicin,Region Östergötland, Endokrinmedicinska kliniken(Swepub:liu)jeawa98 (author)
  • Katsarou, A.Department of Endocrinology, Skåne University Hospital, Malmö, Sweden,Skane Univ Hosp, Sweden (author)
  • Casas, RosauraLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)rosca56 (author)
  • Hernandez, C.Department of Endocrinology and Nutrition, Vall d’Hebron Hospital, CIBERDEM, Barcelona, Spain,Vall dHebron Hosp, Spain (author)
  • Leon, M. C.Department of Endocrinology and Nutrition, Vall d’Hebron Hospital, CIBERDEM, Barcelona, Spain,Vall dHebron Hosp, Spain (author)
  • Gomez-Gila, A.Pediatric Endocrinology Service, Virgen del Rocío University Hospital, Sevilla, Spain,Virgen Roc Univ Hosp, Spain (author)
  • Lind, Marcus,1976Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine,Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden; Department of Medicine, Department of Medicine, Uddevalla, Sweden,Univ Gothenburg, Sweden; Dept Med, Sweden(Swepub:gu)xostem (author)
  • Lozano, M. F.Department of Pediatric Endocrinology, Miguel Servet University Hospital, Zaragoza, Spain,Miguel Servet Univ Hosp, Spain (author)
  • Sas, T.Diabeter, National Treatment and Research Center for Children, Adolescents and Young Adults With Type 1 Diabetes, and Department of Pediatric Endocrinology, Erasmus University Medical Center, Rotterdam, the Netherlands (author)
  • Samuelsson, Ulf,1951-Linköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten,Region Östergötland, H.K.H. Kronprinsessan Victorias barn- och ungdomssjukhus(Swepub:liu)ulfsa43 (author)
  • Pruhova, S.Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic,Charles Univ Prague, Czech Republic; Motol Univ Hosp, Czech Republic (author)
  • Dietrich, FabriciaLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)fabdi90 (author)
  • Puente Marin, SaraLinköpings universitet,Avdelningen för barns och kvinnors hälsa,Medicinska fakulteten(Swepub:liu)sarpu32 (author)
  • Nordlund, A.Trial Form Support, Lund, Sweden (author)
  • Hannelius, U.Diamyd Medical AB, Stockholm, Sweden,Diamyd Med AB, Sweden (author)
  • Casas, R. (author)
  • Linköpings universitetAvdelningen för barns och kvinnors hälsa (creator_code:org_t)

Related titles

  • In:Diabetes Care: American Diabetes Association44:7, s. 1604-16120149-59921935-5548

Internet link

Find in a library

To the university's database

  • 1 of 1
  • Previous record
  • Next record
  •    To hitlist

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

 
pil uppåt Close

Copy and save the link in order to return to this view