Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940835
• Other study ID #: 12-003972
• Status: Completed
• Start date: September 2013
• Est. completion date: June 19, 2019

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This purpose of this study is to determine if activation of a person's immune system in the small intestine could be a contributing cause of Type 1 Diabetes.

Description:

There is a large body of literature hinting at a role of the gut in Type One Diabetes (T1D) pathogenesis. However, to the best of our knowledge there is no definitive evidence to date conclusively demonstrating a link. The only way to test this hypothesis is to have access to the intestinal tissue of T1D patients at very early stages when beta-islet cell destruction is still ongoing. Furthermore, to prepare for large prospective studies it is critical to determine whether there is a peripheral blood signature for intestinal inflammation. Finally, because enteroviral infections have been implicated in T1D pathogenesis, this study provides a unique opportunity to determine whether there is a dysregulated response to innate stimuli associated with viral infections and whether evidence of transcriptional signatures indicative of viral infections in the gut is correlated with disease. Finally, we will take advantage of this pilot study to collect samples that can be used for microbiome, virome and metabolic studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

For the Diabetes Cohort:

Inclusion Criteria:

• Initial diagnosis for Type 1 Diabetes Mellitus (DM) must be within the past 6 months.
• Clinical criteria used to diagnose T1D include at least some of the following :

Diabetic ketoacidosis, Polyuria, Polydipsia, weight loss, need for insulin from diagnosis, BMI less than 30, C-peptide < 200 pmol/L or 0.6 ng/ml, Presence of Type 1 Diabetes Associated Antibodies

Exclusion Criteria:

• Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation with 4 weeks of the studies, and smokers
• Subjects will be asked not to take any probiotics in the week before testing.
• Any known intestinal inflammation such as Gastroesophageal Reflux Disease (GERD), eosinophilic esophagitis, and inflammatory bowel disease.
• Prior gastrointestinal surgery (other than appendectomy)
• Ongoing use of antiplatelet agents or anticoagulants.
• Diabetic patients should not have a prior history of or family history of Celiac Disease (CD).
• Subjects unable to provide informed consent
• The presence of any medical or psychological condition that could interfere with the safe performance of the upper endoscopy.
• Females cannot be pregnant For the Healthy Control Cohort:

Inclusion Criteria:

• Healthy subjects

Exclusion Criteria:

• Controls should not have a family history of DM or CD
• Subjects on antibiotics, proton pump inhibitors, aspirin, non-steroidal anti-inflammatory drugs, alcohol intake within 48 hours, a bowel preparation with 4 weeks of the studies, and smokers
• Subjects will be asked not to take any probiotics in the week before testing.
• Any known intestinal inflammation such as Gastroesophageal Reflux Disease (GERD), eosinophilic esophagitis, and inflammatory bowel disease.
• Prior gastrointestinal surgery (other than appendectomy)
• Ongoing use of antiplatelet agents or anticoagulants.
• Subjects unable to provide informed consent
• The presence of any medical or psychological condition that could interfere with the safe performance of the upper endoscopy.
• Females cannot be pregnant

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Inflammation
• Type 1 Diabetes

Intervention

Procedure:
• Upper endoscopy with small bowel biopsies and brushings.

Other:
• Blood draw
Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).
• Stool sample
Stool samples will be collected at baseline for future microbiome and virome studies.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Mayo Clinic	Harvard University, Juvenile Diabetes Research Foundation, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Interleukin 15 (IL-15) Expression		baseline, 3 months

External Links

•   Mayo Clinic Clinical Trials