Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

Not Applicable

Completed

• Conditions: Type1diabetes
• Interventions: Other: Gluten and Amylase Trypsin Inhibitors (ATI)-free diet

• Registration Number: NCT03443180
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

Siblings of those with type 1 diabetes are at an increased risk of developing the disease themselves. Through prior research, the investigators have found that siblings as well as those with type 1 diabetes have a general level of inflammation in the body. The investigators are examining the role that diet plays in this level of inflammation by asking siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after the diet is completed and again 4 weeks after participants resume their normal diet.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-23
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Males and females 2-23 years of age
2. Full-sibling of an individual with a clinical diagnosis of type 1 diabetes
3. Treatment naïve of any immunomodulatory agent

Exclusion Criteria

1. Abnormal HbA1c, defined as ≥ 6%
2. Previous or current use of a gluten-free diet
3. Current diagnosis of celiac disease
4. An elevated tissue transglutaminase IgA level (> 10 units/mL)
5. Chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
6. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
7. Use of any medications that affect glucose metabolism (e.g., metformin) or the immune system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous) within the previous 3 months)
8. Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
9. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary intervention	Gluten and Amylase Trypsin Inhibitors (ATI)-free diet	Participants will be asked to remove food containing gluten and ATI from their diets for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in the plasma-induced transcriptional assay	2 years (study duration)	Investigators will measure the participants overall immune inflammation and regulation by a plasma-induced transcriptional bioassay. The change in this bioassay will be determined for each subject and the entire group both before and after the dietary intervention. This bioassay informs the investigators of which genes may be positively or negatively impacted by this dietary change and whether the removal of gluten and amylase trypsin inhibitors (ATI) affects a participant's immune state.

Secondary Outcome Measures

Name	Time	Method
Leukocyte analyses	2 years (study duration)	The degree of responsiveness of participants leukocytes to stimulation with gluten and amylase trypsin inhibitors (ATI) will be measured in vitro both before and after the dietary intervention.
Stool microbial composition	2 years (study duration)	Stool samples will be collected both before and after the dietary intervention to determine if the removal of gluten and amylase trypsin inhibitors (ATI) from the diet affects the composition and density of the stool microbiota
Plasma microbial antigen detection	2 years (study duration)	Microbial antigen levels in the plasma of participants will be assayed both before and after the dietary intervention. Systemic microbial antigens are a marker of intestinal permeability so this measure will tell the investigators if the removal of gluten and amylase trypsin inhibitors (ATI) affects the degree of intestinal permeability/leakiness.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States