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Oral insulin therap...
Oral insulin therapy for primary prevention of type 1 diabetes in infants with high genetic risk : The GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) study protocol
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- Ziegler, Anette Gabriele (författare)
- Technical University of Munich,Helmholtz Zentrum München,Klinikum rechts der Isar
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- Achenbach, Peter (författare)
- Helmholtz Zentrum München,Technical University of Munich,Klinikum rechts der Isar
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- Berner, Reinhard (författare)
- Dresden University of Technology,University Clinic Carl Gustav Carus at the TU Dresden
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- Casteels, Kristina (författare)
- Catholic University of Leuven,University Hospitals Leuven
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- Danne, Thomas (författare)
- Children's Hospital Auf der Bult
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- Gündert, Melanie (författare)
- Helmholtz Zentrum München
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- Hasford, Joerg (författare)
- Ludwig-Maximilian University of Munich
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- Hoffmann, Verena Sophia (författare)
- Helmholtz Zentrum München
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- Kordonouri, Olga (författare)
- Children's Hospital Auf der Bult
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- Lange, Karin (författare)
- Hannover Medical School
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- Elding Larsson, Helena (författare)
- Lund University,Lunds universitet,Pediatrisk endokrinologi,Forskargrupper vid Lunds universitet,Paediatric Endocrinology,Lund University Research Groups,Skåne University Hospital
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- Lundgren, Markus (författare)
- Lund University,Lunds universitet,Pediatrisk endokrinologi,Forskargrupper vid Lunds universitet,Paediatric Endocrinology,Lund University Research Groups
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- Snape, Matthew D. (författare)
- Oxford University Hospital,University of Oxford
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- Szypowska, Agnieszka (författare)
- Medical University of Warsaw
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- Todd, John A. (författare)
- University of Oxford
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- Bonifacio, Ezio (författare)
- Dresden University of Technology
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(creator_code:org_t)
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- 2019-06-28
- 2019
- Engelska 9 s.
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 9:6
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://bmjopen.bmj....
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Introduction The POInT study, an investigator initiated, randomised, placebo-controlled, double-blind, multicentre primary prevention trial is conducted to determine whether daily administration of oral insulin, from age 4.0 months to 7.0 months until age 36.0 months to children with elevated genetic risk for type 1 diabetes, reduces the incidence of beta-cell autoantibodies and diabetes. Methods and analysis Infants aged 4.0 to 7.0 months from Germany, Poland, Belgium, UK and Sweden are eligible if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies as determined by genetic risk score or family history and human leucocyte antigen genotype. Infants are randomised 1:1 to daily oral insulin (7.5 mg for 2 months, 22.5 mg for 2 months, 67.5 mg until age 36.0 months) or placebo, and followed for a maximum of 7 years. Treatment and follow-up is stopped if a child develops diabetes. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies or diabetes. Other outcomes are: (1) Any persistent confirmed beta-cell autoantibody (glutamic acid decarboxylase (GADA), IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4) Abnormal glucose tolerance or diabetes. Ethics and dissemination The study is approved by the ethical committees of all participating clinical sites. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial. Trial registration number NCT03364868.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
Nyckelord
- clinical trials
- general diabetes
- paediatric endocrinology
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- Av författaren/redakt...
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Ziegler, Anette ...
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Achenbach, Peter
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Berner, Reinhard
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Casteels, Kristi ...
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Danne, Thomas
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Gündert, Melanie
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visa fler...
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Hasford, Joerg
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Hoffmann, Verena ...
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Kordonouri, Olga
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Lange, Karin
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Elding Larsson, ...
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Lundgren, Markus
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Snape, Matthew D ...
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Szypowska, Agnie ...
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Todd, John A.
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Bonifacio, Ezio
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Endokrinologi oc ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Pediatrik
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BMJ Open
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Lunds universitet