Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01940835

Enrollment

Registered

2013-09-12

Start date

2013-09-30

Completion date

2019-06-19

Last updated

2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief 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.

Detailed 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.

Interventions

PROCEDUREUpper endoscopy with small bowel biopsies and brushings.

OTHERBlood draw

Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).

OTHERStool sample

Stool samples will be collected at baseline for future microbiome and virome studies.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mean Interleukin 15 (IL-15) Expression	baseline, 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026