Preservation of Residual Beta Cell Mass and Prevention of Celiac Disease in Children With Recent Onset Type 1 Diabetes (Diabglut)
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|ClinicalTrials.gov Identifier: NCT03037190|
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : August 23, 2018
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.
• 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Remission Celiac Disease in Children||Other: withdrawal of gluten from the diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||•The trial is designed as a 2-arm not randomized, open, multicentre study comparing 1 year of gluten free diet with normal diet|
|Masking:||None (Open Label)|
|Official Title:||Investigation 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.|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Group A
Group A:withdrawal of gluten from the diet, Group A will have a gluten free diet for a year after the onset of diabetes
Other: withdrawal of gluten from the diet
Gluten free diet the same recommendations as for patients with diabetes and known celiac disease
No Intervention: B normal diet
Group B will have normal not glutenfree diet, no planned intervention
- Preservation of beta cells function [ Time Frame: within 2years after the onset of type 1 diabetes ]Differences in c-peptide production between the Groups A and B, 12 and 18 months after the onset of diabetes.
- Prevention of Celiac DIsease [ Time Frame: Five years after the onset of Diabetes ]Differencies in incidence of Celiac Disease between the two groups, after onset of diabetes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037190
|Contact: Annelie Carlsson, MD PhDfirstname.lastname@example.org|
|Contact: Iren Tiberg, MD PhDemail@example.com|
|Principal Investigator:||Annelie Carlsson, MD PhD||Lund University|