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

IntroductionThe 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...

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Vydané v:BMJ open Ročník 9; číslo 6; s. e028578
Hlavní autori: Ziegler, Anette-Gabriele, Achenbach, Peter, Berner, Reinhard, Casteels, Kristina, Danne, Thomas, Gündert, Melanie, Hasford, Joerg, Hoffmann, Verena Sophia, Kordonouri, Olga, Lange, Karin, Elding Larsson, Helena, Lundgren, Markus, Snape, Matthew D, Szypowska, Agnieszka, Todd, John A, Bonifacio, Ezio
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England BMJ Publishing Group LTD 28.06.2019
BMJ Publishing Group
Predmet:
Administration, Oral
Age
Antigens
Autoantibodies - analysis
Babies
Clinical Medicine
Clinical trials
Diabetes
Diabetes and Endocrinology
Diabetes Mellitus, Type 1 - genetics
Diabetes Mellitus, Type 1 - immunology
Diabetes Mellitus, Type 1 - prevention & control
Disease prevention
Endocrinology and Diabetes
Endokrinologi och diabetes
Europe
Evidence-based medicine
Family medical history
Female
Genetic Predisposition to Disease
Genotype & phenotype
Haplotypes
Health risk assessment
Humans
Hypoglycemic Agents - administration & dosage
Infant
Insulin
Insulin - administration & dosage
Klinisk medicin
Male
Medical and Health Sciences
Medicin och hälsovetenskap
Outcome Assessment, Health Care - methods
Pediatrics
Pediatrik
Primary Prevention
Randomized Controlled Trials as Topic - methods
Risk Assessment - methods
Vitamin deficiency
Europe
Poland
Sweden
United Kingdom > UK
Belgium
Germany
general diabetes
clinical trials
paediatric endocrinology
ISSN:2044-6055, 2044-6055
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Shrnutí:IntroductionThe 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 analysisInfants 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 disseminationThe 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.
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2018-028578