Trial Outcomes & Findings for The Effect of Gluten-free Diet on New Onset Type 1 Diabetes (T1D) (NCT NCT02867436)
NCT ID: NCT02867436
Last Updated: 2024-09-19
Results Overview
Area under the curve of C-peptide in MMT test at 0, 30, 60, 90 and 120 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Month 1 (baseline) - Month 12 (end of intervention)
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Gluten-free Diet
Gluten-free diet for pediatric patients with type 1 diabetes
|
Conventional Diet
Conventional gluten-containing diet for pediatric patients with type 1 diabetes
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
19
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gluten-free Diet
n=26 Participants
Gluten-free diet for pediatric patients with type 1 diabetes
|
Conventional Diet
n=19 Participants
Conventional gluten-containing diet for pediatric patients with type 1 diabetes
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=26 Participants
|
19 Participants
n=19 Participants
|
45 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=45 Participants
|
|
Age, Continuous
|
10.7 years
STANDARD_DEVIATION 3.2 • n=26 Participants
|
10.1 years
STANDARD_DEVIATION 3.5 • n=19 Participants
|
10.2 years
STANDARD_DEVIATION 3.3 • n=45 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=26 Participants
|
3 Participants
n=19 Participants
|
16 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=26 Participants
|
16 Participants
n=19 Participants
|
29 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Czechia
|
26 participants
n=26 Participants
|
19 participants
n=19 Participants
|
45 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Month 1 (baseline) - Month 12 (end of intervention)Area under the curve of C-peptide in MMT test at 0, 30, 60, 90 and 120 minutes.
Outcome measures
| Measure |
Gluten-free Diet
n=20 Participants
Gluten-free diet
Gluten-free diet
|
Conventional Diet
n=19 Participants
Conventional diet
|
|---|---|---|
|
Change in C-peptide Area Under the Curve Measured by Mixed-meal Tolerance Test (MMTT) Between Group on GFD and Standard Gluten-containing Diet.
|
1539 pmol*min/l
Standard Deviation 1255
|
1173 pmol*min/l
Standard Deviation 1006
|
SECONDARY outcome
Timeframe: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)Outcome measures
| Measure |
Gluten-free Diet
n=20 Participants
Gluten-free diet
Gluten-free diet
|
Conventional Diet
n=19 Participants
Conventional diet
|
|---|---|---|
|
Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.
HbA1c at 6 months
|
44.8 mmol/mol
Standard Deviation 6.3
|
47.2 mmol/mol
Standard Deviation 8.3
|
|
Changes in Mean HbA1c at 6 and 12 Months Relative to Baseline at Month 1.
HbA1c at 12 months
|
44 mmol/mol
Standard Deviation 9.5
|
52.2 mmol/mol
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Month 1 (baseline) - Month 6 - Month 12 (end of intervention)Outcome measures
| Measure |
Gluten-free Diet
n=20 Participants
Gluten-free diet
Gluten-free diet
|
Conventional Diet
n=19 Participants
Conventional diet
|
|---|---|---|
|
Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.
Insulin dose at 6 months
|
0.41 U/kg/day
Standard Deviation 0.17
|
0.62 U/kg/day
Standard Deviation 0.23
|
|
Changes in Mean Insulin Dose at 6 and 12 Months Relative to Baseline at Month 1.
Insulin dose at 12 months
|
0.50 U/kg/day
Standard Deviation 0.22
|
0.75 U/kg/day
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Month 1 (baseline) - Month 12 (end of intervention)Outcome measures
| Measure |
Gluten-free Diet
n=20 Participants
Gluten-free diet
Gluten-free diet
|
Conventional Diet
n=19 Participants
Conventional diet
|
|---|---|---|
|
Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.
TEMRA cells at 12 months
|
8 % of cells
Standard Deviation 2.2
|
12.5 % of cells
Standard Deviation 3.5
|
|
Changes in Immunological Parameters (FoxP3 Tregs, Th1 and Th17 Counts) at 12 Months Relative to Baseline at Month 1.
T-regulatory cells type 1 at 12 months
|
1.02 % of cells
Standard Deviation 0.63
|
0.46 % of cells
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: Month 1 (before intervention) - Pooled values throughout the intervention (months 3-12) - Month 15 (after intervention)Measures are shown as pooled values at all timepoints during the intervention period compared to control group throughout the same time-period.
Outcome measures
| Measure |
Gluten-free Diet
n=22 Participants
Gluten-free diet
Gluten-free diet
|
Conventional Diet
n=19 Participants
Conventional diet
|
|---|---|---|
|
Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration
Bifidobacterium
|
3.3 Percentage of microbes
|
8 Percentage of microbes
|
|
Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration
Roseburia
|
3.2 Percentage of microbes
|
1.2 Percentage of microbes
|
|
Differences in Fecal Microbiome Between Children on Normal Diet and Children on Gluten-free Diet Over the First Year of Diabetes Duration
Lachnospira
|
1.01 Percentage of microbes
|
0.21 Percentage of microbes
|
Adverse Events
Gluten-free Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place