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.
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

September 9, 2013
April 1, 2014
September 2013
September 2015   (final data collection date for primary outcome measure)
Mean Interleukin 15 (IL-15) Expression [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01940835 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes
Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Type 1 Diabetes, diagnosed within 6 months

Type 1 Diabetes
  • 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.
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Procedure: Upper endoscopy with small bowel biopsies and brushings.
    • Other: Blood draw
    • Other: Stool sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact: Carol Van Dyke 507-266-7842 vandyke.carol@mayo.edu
United States
 
NCT01940835
12-003972
No
Joseph A. Murray, M.D., Mayo Clinic
Mayo Clinic
  • Juvenile Diabetes Research Foundation
  • University of Chicago
  • Harvard University
Principal Investigator: Joseph Murray, M.D. Mayo Clinic
Mayo Clinic
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP