Status:
COMPLETED
Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Type1diabetes
Eligibility:
All Genders
2-23 years
Phase:
NA
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 di...
Eligibility Criteria
Inclusion
- Males and females 2-23 years of age
- Full-sibling of an individual with a clinical diagnosis of type 1 diabetes
- Treatment naïve of any immunomodulatory agent
Exclusion
- Abnormal HbA1c, defined as ≥ 6%
- Previous or current use of a gluten-free diet
- Current diagnosis of celiac disease
- An elevated tissue transglutaminase IgA level (\> 10 units/mL)
- 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)
- 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
- 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)
- Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03443180
Start Date
January 1 2018
End Date
March 9 2020
Last Update
April 29 2025
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226