Can Gluten-free Diet Prevent the Destruction of Beta-cells During Remission?

NCT02284815 | Unknown Early Phase 1 DMC

• 1 other identifier: DIRECT-2011-119
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 1 diabetes (T1D) emerge when the auto-immune destruction exceeds the beta cell's regenerative capacity. The patients' beta-cell capacity increases shortly after onset when glucotoxicity decreases after the start of insulin therapy. Children have fewer beta cells and therefore shorter remission; but the expansion potential is larger the younger the child is. The problem with the majority of intervention studies is the many and serious side effects, or a quite marginal effect on the residual beta-cell function. However, in animals that had received gluten-free diet, the T1D incidence fell from 61% to only 6%. Gluten-free diet increases the number of regulatory T cells in Peyer's patches, affect the composition of intestinal microflora and modify the balance between pro and anti-inflammatory cytokines in T cells. Therefore, the aim of our study is to prolong the remission phase by introducing a gluten-free diet intervention to children at T1D onset.

Conditions

Diabetes Mellitus, Type 1

Keywords

Gluten; T1D; Remission

Outcome Measures

Primary Outcomes (3)

• C-peptide change from baseline to 12 months follow-up

  Stimulated C-peptide

  12 months

• Insulin Adjusted HbA1c change from baseline to 12 months follow-up

  4\*insulin + HbA1c (%)

  12 months

• Insulin per kg from baseline to 12 months follow-up

  total insulin dose per day

  12 months

Secondary Outcomes (2)

• Microbiota (feces samples) change from baseline to 6 months follow-up

  6 months

• Immune system (Th1 and Th2 cytokines) change from baseline to 12 months follow-up

  12 months

Study Arms (2)

Glutenfree diet

ACTIVE COMPARATOR

Self-chosen glutenfree diet

Dietary Supplement: Glutenfree diet

Normal diet

PLACEBO COMPARATOR

Those not following the glutenfree diet

Interventions

Glutenfree diet DIETARY_SUPPLEMENT

Newly diagnosed children could choose glutenfree diet

Glutenfree diet

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed with type 1 diabetes (duration \< 3 month)

You may not qualify if:

• Diabetes duration \> 3 months,
• not type 1 diabetes

Sponsors & Collaborators

• Herlev Hospital: lead

Related Publications (1)

• Svensson J, Sildorf SM, Pipper CB, Kyvsgaard JN, Bojstrup J, Pociot FM, Mortensen HB, Buschard K. Potential beneficial effects of a gluten-free diet in newly diagnosed children with type 1 diabetes: a pilot study. Springerplus. 2016 Jul 7;5(1):994. doi: 10.1186/s40064-016-2641-3. eCollection 2016.

  PMID: 27398272 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jannet Svensson, Phd

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 6, 2014
• Study Start: March 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 6, 2014

Record last verified: 2014-11