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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03037190
Other study ID # LUDU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date December 2020

Study information

Verified date August 2018
Source Lund University
Contact Annelie Carlsson, MD PhD
Phone +46768267170
Email annelie.carlsson@med.lu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall aim of this project is to investigate whether a gluten free diet after the onset of type 1 diabetes (T1D) can better preserve the remaining beta cell mass and at the same time prevent the development of Celiac Disease (CD) in these patients.

Specific aims

• To study whether gluten free diet during one year after the onset of diabetes influence the appearance and duration of clinical remission in children with Type 1 diabetes.

New data show that a gluten free diet is beneficial concerning the insulin production after the onset of diabetes. The investigators want to investigate if gluten is a triggering protein for the destruction of the beta cell function after the onset of diabetes by comparing children who have a normal diet compared to children with a gluten free diet during one year after the onset of the disease.

- To study whether a gluten free diet during one year after the onset of diabetes prevent the development of Celiac Disease in these children and the impact of having two diseases It is known that it is almost 10 times more common that children with Type 1 Diabetes (IDDM) develop Celiac Disease (CD) than the general population and that most of these children (6-7 %) develop CD after the onset of Diabetes and within 5 years. Based on our new data that CD is preventable to some extent the investigators plan to perform randomized controlled studies if it is possible to prevent or postpone CD by means after the onset of IDDM.

- To investigate the impact of gluten free diet on the regulation of autoimmune responses The investigators will test the hypothesis that gluten free diet in children with recent onset T1D will implement immune regulation and inhibit the activation of potentially autoreactive T cells.


Description:

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Study Design


Intervention

Other:
withdrawal of gluten from the diet
Gluten free diet the same recommendations as for patients with diabetes and known celiac disease

Locations

Country Name City State
Sweden Skanes University Hospital Lund Region Skane

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Hummel S, Pflüger M, Hummel M, Bonifacio E, Ziegler AG. Primary dietary intervention study to reduce the risk of islet autoimmunity in children at increased risk for type 1 diabetes: the BABYDIET study. Diabetes Care. 2011 Jun;34(6):1301-5. doi: 10.2337/dc10-2456. Epub 2011 Apr 22. — View Citation

Ivarsson A, Myléus A, Norström F, van der Pals M, Rosén A, Högberg L, Danielsson L, Halvarsson B, Hammarroth S, Hernell O, Karlsson E, Stenhammar L, Webb C, Sandström O, Carlsson A. Prevalence of childhood celiac disease and changes in infant feeding. Pediatrics. 2013 Mar;131(3):e687-94. doi: 10.1542/peds.2012-1015. Epub 2013 Feb 18. — View Citation

Pastore MR, Bazzigaluppi E, Belloni C, Arcovio C, Bonifacio E, Bosi E. Six months of gluten-free diet do not influence autoantibody titers, but improve insulin secretion in subjects at high risk for type 1 diabetes. J Clin Endocrinol Metab. 2003 Jan;88(1):162-5. — View Citation

Sildorf SM, Fredheim S, Svensson J, Buschard K. Remission without insulin therapy on gluten-free diet in a 6-year old boy with type 1 diabetes mellitus. BMJ Case Rep. 2012 Jun 21;2012. pii: bcr0220125878. doi: 10.1136/bcr.02.2012.5878. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Preservation of beta cells function Differences in c-peptide production between the Groups A and B, 12 and 18 months after the onset of diabetes. within 2years after the onset of type 1 diabetes
Secondary Prevention of Celiac DIsease Differencies in incidence of Celiac Disease between the two groups, after onset of diabetes Five years after the onset of Diabetes
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