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Preservation of Residual Beta Cell Mass and Prevention of Celiac Disease in Children With Recent Onset Type 1 Diabetes (Diabglut)

This study is currently recruiting participants.
Verified January 2017 by Annelie Carlsson, Lund University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03037190
First Posted: January 31, 2017
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Annelie Carlsson, Lund University
  Purpose

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.

Condition Intervention
Diabetes Mellitus, Type 1 Remission Celiac Disease in Children Other: withdrawal of gluten from the diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Annelie Carlsson, Lund University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 160
Actual Study Start Date: December 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes according to the ADA classification with < 1 months diabetes duration at time of screening
  • Age 3.00 -17.99 years at time of screening
  • Fasting C-peptide at time of screening ≥ 0.12 nmol/L

Exclusion Criteria:

  • Inability or unwillingness to comply with the provisions of this protocol
  • Deemed by the investigator not being able to follow instructions and/or follow the study protocol

NB: new ethical approval will be applied for children between 1-3 years of age

  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Annelie Carlsson, MD PhD +46768267170 annelie.carlsson@med.lu.se
Contact: Iren Tiberg, MD PhD iren.tiberg@med.lu.se

Locations
Sweden
Skanes University Hospital Recruiting
Lund, Region Skane, Sweden, 22185
Contact: Annelie Carlsson, MD PhD    +46768267170    annelie.carlsson@med.lu.se   
Contact: Iren Tiberg, PhD, nurse       iren.tiberg@med.lu.se   
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Annelie Carlsson, MD PhD Lund University
  More Information

Publications:
Responsible Party: Annelie Carlsson, Associate Professor, Lund University
ClinicalTrials.gov Identifier: NCT03037190     History of Changes
Other Study ID Numbers: LUDU
First Submitted: January 26, 2017
First Posted: January 31, 2017
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Celiac Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases


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