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Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

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ClinicalTrials.gov Identifier: NCT03443180
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Susanne Cabrera, 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.

Condition or disease Intervention/treatment Phase
Type1diabetes Other: Gluten and Amylase Trypsin Inhibitors (ATI)-free diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive a dietary intervention. They will be instructed and asked to follow a diet free of gluten and the protein amylase trypsin inhibitors (ATI), which is frequently found in gluten-containing foods, for four weeks. They will then be asked to resume their normal diet.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Gluten and Amylase Trypsin Inhibitors (ATI) as Nutritional Contributors to Type 1 Diabetes Susceptibility
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Trypsin

Arm Intervention/treatment
Dietary intervention
Participants will be asked to remove food containing gluten and ATI from their diets for 4 weeks.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females 5-17 years of age
  2. Full-sibling of an individual with a clinical diagnosis of type 1 diabetes
  3. Treatment naïve of any immunomodulatory agent
  4. HLA haplotype other than high-risk haplotype of DR3/DR4
  5. Absence of type 1 diabetes autoantibodies

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443180


Contacts
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Contact: Susanne Cabrera, MD 414-955-4903 t1dinfo@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Susanne Cabrera, MD    414-955-4903    t1dinfo@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin

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Responsible Party: Susanne Cabrera, Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03443180     History of Changes
Other Study ID Numbers: 1138159
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susanne Cabrera, Medical College of Wisconsin:
Siblings

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action