Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

  • Study type:

    Observational What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 12-003972
  • NCT ID:

    NCT01940835
  • Sponsor Protocol Number:

    12-003972

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Contact us for the latest status

Carol Van Dyke CCRP

(507)266-7842

vandyke.carol@mayo.edu