Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

NCT01940835 | Completed

• 1 other identifier: 12-003972
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean Interleukin 15 (IL-15) Expression

  baseline, 3 months

Study Arms (2)

Type 1 Diabetes

Subjects will have an upper endoscopy with small bowel biopsies and brushings. Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC). Stool samples will be collected at baseline for future microbiome and virome studies.

Procedure: Upper endoscopy with small bowel biopsies and brushings.; Other: Blood draw; Other: Stool sample

Healthy Control Group

Subjects will have an upper endoscopy with small bowel biopsies and brushings. Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC). Stool samples will be collected at baseline for future microbiome and virome studies.

Procedure: Upper endoscopy with small bowel biopsies and brushings.; Other: Blood draw; Other: Stool sample

Interventions

Upper endoscopy with small bowel biopsies and brushings. PROCEDURE

Healthy Control Group; Type 1 Diabetes

Blood draw OTHER

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

Healthy Control Group; Type 1 Diabetes

Stool sample OTHER

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

Healthy Control Group; Type 1 Diabetes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Type 1 Diabetes, diagnosed within 6 months

You may qualify if:

• 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

You may not qualify if:

• 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:
• \- Healthy subjects
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Juvenile Diabetes Research Foundation: collaborator
• University of Chicago: collaborator
• Harvard University: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Serum, DNA, RNA extraction, brush biopsies from duodenal mucosa, biopsies of small intestine, stool samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Gastroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Officials

• Joseph Murray, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: September 1, 2013
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: February 2, 2022

Record last verified: 2022-02

Locations

US (1)