The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D)

NCT02867436 | Completed Results

• 1 other identifier: 16-27994A
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim of this pilot study is to test whether gluten-free diet (GFD) instituted in children shortly after onset of Type 1 Diabetes (T1D) can decelerate the decline in beta cell function as compared to age matched controls. Primary objective of the trial is the change in C-peptide area under the curve measured by mixed-meal tolerance test (MMTT) between group on GFD and standard gluten-containing diet. Secondary objectives are:

• Changes in immune parameters between gluten-free diet group and control group;
• Differences in fecal microbiome between children on normal diet and children on GFD;

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.

  Area under the curve of C-peptide in MMT test at 0, 30, 60, 90 and 120 minutes.

  Month 1 (baseline) - Month 12 (end of intervention)

Secondary Outcomes (4)

• Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.

  Month 1 (baseline) - Month 6 - Month 12 (end of intervention)

• Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.

  Month 1 (baseline) - Month 6 - Month 12 (end of intervention)

• Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.

  Month 1 (baseline) - Month 12 (end of intervention)

• Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration

  Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)

Study Arms (2)

Gluten-free diet

EXPERIMENTAL

Gluten-free diet

Other: Gluten-free diet

Conventional diet

NO INTERVENTION

Conventional diet

Interventions

Gluten-free diet OTHER

Gluten-free diet

Eligibility Criteria

• Age: 4 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Type 1 Diabetes (T1D) diagnosed according to the American Diabetes Association criteria

You may not qualify if:

• negativity of the three diabetes-related autoantibodies at T1D onset;
• negativity of celiac-disease high risk Human Leucocyte Antigen DQB1 (HLA-DQB1) and Human Leucocyte Antigen DQA1 (HLA-DQA1) genotype HLA-DQB1\*03:02-DQA1\*03 nor DQB1\*02-DQA1\*05 molecules;
• celiac disease or positive transglutaminase antibody test;
• body mass index over two standard deviations of the age and height standard;
• any concomitant disease potentially influencing immune response or gluten sensitivity

Sponsors & Collaborators

• University Hospital, Motol: lead
• Faculty Hospital Kralovske Vinohrady: collaborator
• Czech Academy of Sciences: collaborator

Study Sites (2)

University Hospital Královské Vinohrady

Prague, 10000, Czechia

Location

University Hospital Motol

Prague, 15006, Czechia

Location

Related Publications (2)

• Neuman V, Pruhova S, Kulich M, Kolouskova S, Vosahlo J, Romanova M, Petruzelkova L, Havlik J, Mascellani A, Henke S, Sumnik Z, Cinek O. Changes in the gut bacteriome upon gluten-free diet intervention do not mediate beta cell preservation. Diabetologia. 2023 Jan;66(1):241-246. doi: 10.1007/s00125-022-05805-3. Epub 2022 Oct 4.

  PMID: 36194251 DERIVED

• Neuman V, Cinek O, Funda DP, Hudcovic T, Golias J, Kramna L, Petruzelkova L, Pruhova S, Sumnik Z. Human gut microbiota transferred to germ-free NOD mice modulate the progression towards type 1 diabetes regardless of the pace of beta cell function loss in the donor. Diabetologia. 2019 Jul;62(7):1291-1296. doi: 10.1007/s00125-019-4869-2. Epub 2019 Apr 25.

  PMID: 31025045 DERIVED

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

Limitations and Caveats

The main limitation is the lack of randomization. Second, the study did not achieve the sample size needed for sufficient power according to the pre-study power analysis. Furthermore, the duration of the study might have been too short for the assessment of the long-term effect of the GFD on the course of T1D.

Results Point of Contact

• Title: Zdeněk Šumník, PI
• Organization: Motol University Hospital

zdenek.sumnik@lfmotol.cuni.cz

+420702000087

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: August 16, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Locations

CZ (2)