Type1diabetes
Conditions
Keywords
Siblings
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.
Interventions
OTHERGluten 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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 23 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the plasma-induced transcriptional assay | 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
| Measure | Time frame | Description |
|---|---|---|
| Stool microbial composition | 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 |
| Plasma microbial antigen detection | 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. |
| Leukocyte analyses | 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. |
Countries
United States
Outcome results
None listed