Trial record 1 of 1 for:    NCT01940835
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Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
University of Chicago
Harvard University
Information provided by (Responsible Party):
Joseph A. Murray, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01940835
First received: September 9, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Procedure: Upper endoscopy with small bowel biopsies and brushings.
Other: Blood draw
Other: Stool sample

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Interleukin 15 (IL-15) Expression [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).
Other: Stool sample
Stool samples will be collected at baseline for future microbiome and virome studies.
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
Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).
Other: Stool sample
Stool samples will be collected at baseline for future microbiome and virome studies.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Type 1 Diabetes, diagnosed within 6 months

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940835

Contacts
Contact: Carol Van Dyke 507-266-7842 vandyke.carol@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Carol Van Dyke    507-266-7842    vandyke.carol@mayo.edu   
Principal Investigator: Joseph Murray, M.D.         
Sponsors and Collaborators
Mayo Clinic
Juvenile Diabetes Research Foundation
University of Chicago
Harvard University
Investigators
Principal Investigator: Joseph Murray, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Joseph A. Murray, M.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01940835     History of Changes
Other Study ID Numbers: 12-003972
Study First Received: September 9, 2013
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Inflammation
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014