Effects of Gluten Free Diet on Type 1 Diabetes Mellitus in Children

NCT02605564 | Terminated

• 1 other identifier: 5140361
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The central hypothesis of this proposal is that a gluten-free diet introduced shortly after diagnosis can reverse or arrest islet destruction in children and adolescents with type 1 diabetes mellitus (T1DM). The specific aims are to determine the effects of a gluten-free diet on 1) endogenous insulin production and 2) the corresponding gut flora of children with new-onset type 1 diabetes. This is a randomized placebo controlled clinical trial testing the effect of altering the gut microbiome via a gluten-free diet on endogenous insulin production as a measure of the pace and severity of islet destruction at the time of diagnosis of type 1 diabetes. The project entails eliminating gluten from the diet of the intervention group and comparing bacterial gut flora and endogenous insulin response with those in a control group up to one year following the diagnosis of type 1 diabetes. The proposal introduces a new potential etiology for type 1 diabetes in humans: the Bacterial Hypothesis. The short term goal is to identify specific islet-preserving microbiome changes induced by eliminating gluten from the diet of patients recently diagnosed with type 1 diabetes. The long term goal is to develop these changes into effective and safe strategies that can allow patients with type 1 diabetes to achieve permanent insulin-independence.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of C-peptide on mixed meal tolerance test

  one year

Study Arms (2)

study Group A

ACTIVE COMPARATOR

Gluten free diet

Other: Gluten Free Diet

Study Group B

PLACEBO COMPARATOR

No intervention

Other: Placebo

Interventions

Gluten Free Diet OTHER

Gluten Free Diet

Also known as: study group A

study Group A

Placebo OTHER

Placebo No intervention, standard T1DM diet

Also known as: Study Group B

Study Group B

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages: 1-17 years
• diagnosis of type 1 diabetes within 4 months of enrollment
• parent or guardian willing to sign informed consent to comply with basal bolus insulin treatment as well as study procedures and diet guidelines

You may not qualify if:

• Diabetes diagnosed under one year of age;
• patients with known malabsorption or malnutrition;
• glycosylated hemoglobin HbA1C value over 9% at three months following diagnosis (a general screen for noncompliance with treatment guidelines)

Sponsors & Collaborators

• Loma Linda University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Eba Hathout, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 16, 2015
• Study Start: January 19, 2016
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10