Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Closed for enrollment

Contact information:

Carol Van Dyke CCRP

(507) 266-7842

VanDyke.Carol@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20113372

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