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Completed

NCT Number: NCT03443180

Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

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.

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Key information

Conditions

Type1diabetes

Age range

2 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Gluten and Amylase Trypsin Inhibitors (ATI)-free diet

Other

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

Primary outcomes

  1. Change in the plasma-induced transcriptional assay

    Time frame: 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 outcomes

  1. Stool microbial composition

    Time frame: 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

  2. Plasma microbial antigen detection

    Time frame: 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.

  3. Leukocyte analyses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2018
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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