Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

Type1diabetes Clinical Trial

Official title:

Gluten and Amylase Trypsin Inhibitors (ATI) as Nutritional Contributors to Type 1 Diabetes Susceptibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443180
• Other study ID #: 1138159
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 9, 2020

Study information

• Verified date: May 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Other:
• Gluten and Amylase Trypsin Inhibitors (ATI)-free diet
Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the plasma-induced transcriptional assay	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.	2 years (study duration)
Secondary	Stool microbial composition	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	2 years (study duration)
Secondary	Plasma microbial antigen detection	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.	2 years (study duration)
Secondary	Leukocyte analyses	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.	2 years (study duration)