Trial reportDiabetologia2005
Dietary manipulation of beta cell autoimmunity in infants at increased risk of type 1 diabetes: a pilot study.
Trial report in Diabetologia, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
TRIGR - Trial to Reduce IDDM in the Genetically at Risk
Trial to Reduce IDDM in the Genetically at Risk (TRIGR): the Pilot Study
Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 147 citations in OpenAlex.
- Infant formulas containing hydrolysed protein for prevention of allergic disease.The Cochrane database of systematic reviews · 2018Pooled it
- Hydrolysed formula and risk of allergic or autoimmune disease: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2016Pooled it
- Effect of docosahexaenoic acid supplementation on inflammatory cytokine levels in infants at high genetic risk for type 1 diabetes.Pediatric diabetes · 2015Trial
- Trial
- Feasibility and compliance in a nutritional primary prevention trial in infants at increased risk for type 1 diabetes.Acta paediatrica (Oslo, Norway : 1992) · 2011Trial
- The Trial to Reduce IDDM in the Genetically at Risk (TRIGR) study: recruitment, intervention and follow-up.Diabetologia · 2011Trial
- Dietary intervention in infancy and later signs of beta-cell autoimmunity.The New England journal of medicine · 2010Trial
- Enhanced levels of cow's milk antibodies in infancy in children who develop type 1 diabetes later in childhood.Pediatric diabetes · 2008Trial
- Diet, gut microbiome, and type 1 diabetes: from risk to translational opportunity.Gut microbes · 2026Review
- Mechanistic Insights into Immune-Microbiota Interactions and Preventive Role of Probiotics Against Autoimmune Diabetes Mellitus.Probiotics and antimicrobial proteins · 2023Review
- Prevention of Type 1 Diabetes in Children: A Worthy Challenge?International journal of environmental research and public health · 2023Review
- Receptor for Advanced Glycation End Products (RAGE) in Type 1 Diabetes Pathogenesis.Current diabetes reports · 2016Review
- Engineering the gut for insulin replacement to treat diabetes.Journal of diabetes investigation · 2016Review
- The role for gut permeability in the pathogenesis of type 1 diabetes--a solid or leaky concept?Pediatric diabetes · 2015Review
- Luminex and other multiplex high throughput technologies for the identification of, and host response to, environmental triggers of type 1 diabetes.BioMed research international · 2015Review
- Lessons from type 1 diabetes for understanding natural history and prevention of autoimmune disease.Rheumatic diseases clinics of North America · 2014Review
- Progress in immune-based therapies for type 1 diabetes.Clinical and experimental immunology · 2013Review
- Type 1 diabetes: translating mechanistic observations into effective clinical outcomes.Nature reviews. Immunology · 2013Review
- Pathogenesis of type 1 diabetes: lessons from natural history studies of high-risk individuals.Annals of the New York Academy of Sciences · 2013Review
- Harnessing memory adaptive regulatory T cells to control autoimmunity in type 1 diabetes.Journal of molecular cell biology · 2012Review
Corrections and comments
- Erratum issuedRiikjärv, MA [added]; Ormisson, A [added]; Ludvigsson, J [added]; Dosch, HM [added]; Hakulinen, T [added]; Knip, M [added]
Authors and funding
16 authors at 11 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisWe aimed to assess the feasibility of a dietary intervention trial with weaning to hydrolysed formula in infants at increased risk of type 1 diabetes and to study the effect of the intervention on the emergence of diabetes-associated autoantibodies in early childhood.
methodsWe studied 242 newborn infants who had a first-degree relative with type 1 diabetes and carried risk-associated HLA-DQB1 alleles. After exclusive breastfeeding, the infants underwent a double-blind, randomised pilot trial of either casein hydrolysate (Nutramigen; Mead Johnson) or conventional cow's milk-based formula until the age of 6-8 months. During a mean observation period of 4.7 years, autoantibodies to insulin, anti-glutamic acid decarboxylase and insulinoma-associated antigen-2 were measured by radiobinding assays, and islet cell antibodies (ICA) by immunofluorescence.
resultsThe feasibility of screening and identifying a cohort of first-degree relatives with HLA-conferred disease susceptibility, enrolling them in a dietary intervention trial and following them for seroconversion to autoantibody positivity is established. The cumulative incidence of autoantibodies was somewhat smaller in the casein hydrolysate vs control formula group, suggesting the need for a larger well-powered study. After adjustment for duration of study formula feeding, life-table analysis showed a significant protection by the intervention from positivity for ICA (p=0.02) and at least one autoantibody (p=0.03). CONCLUSIONS/
interpretationThe present study provides the first evidence ever in man, despite its limited power, that it may be possible to manipulate spontaneous beta cell autoimmunity by dietary intervention in infancy.
Indexed as
Identifiers
What OpenQuestion holds
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.