Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

NCT ID: NCT03443180

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-03-09

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.

Conditions

Type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dietary intervention

Participants will be asked to remove food containing gluten and ATI from their diets for 4 weeks.

Group Type: OTHER

Gluten and Amylase Trypsin Inhibitors (ATI)-free diet

Intervention Type: OTHER

Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Susanne Cabrera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

1138159

Identifier Type: -

Identifier Source: org_study_id