Type 1 DiabetesNCT01940835
Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Upper endoscopy with small bowel biopsies and brushings., Blood draw and Stool sample
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 19 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Type 1 Diabetes, diagnosed within 6 months
Who may be able to join
- 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
- Healthy subjects
Who cannot join
- 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).
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- 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:
- 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
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Upper endoscopy with small bowel biopsies and brushings., Blood draw, Stool sample
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper endoscopy with small bowel biopsies and brushings.Procedure or surgery
Blood drawOther
Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).
Stool sampleOther
Stool samples will be collected at baseline for future microbiome and virome studies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Upper endoscopy with small bowel biopsies and brushings.; Other: Blood draw; Other: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Interleukin 15 (IL-15) Expression
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startSep 2013
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, University of Chicago, Harvard University
- Responsible party
- Principal investigator, Joseph A. Murray, M.D., Mayo Clinic
- Investigators
- Joseph Murray, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940835
- Sponsor's protocol ID
- 12-003972
- Status last verified
- Feb 2022
- First submitted
- 9 Sep 2013
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01940835
- Acronym / sponsor ID
- 12-003972
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, University of Chicago, Harvard University
- Study start
- Sep 2013 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | Procedure: Upper endoscopy with small bowel biopsies and brushings., Other: Blood draw, Other: Stool sampleSubjects 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. |
| Healthy Control Group | – | Procedure: Upper endoscopy with small bowel biopsies and brushings., Other: Blood draw, Other: Stool sampleSubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Type 1 Diabetes, diagnosed within 6 months
Key inclusion criteria (3 listed)
- 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
- Healthy subjects
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper endoscopy with small bowel biopsies and brushings. | Procedure or surgery | Healthy Control Group, Type 1 Diabetes |
| Blood drawBlood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC). | Other | Healthy Control Group, Type 1 Diabetes |
| Stool sampleStool samples will be collected at baseline for future microbiome and virome studies. | Other | Healthy Control Group, Type 1 Diabetes |
Primary outcome
Mean Interleukin 15 (IL-15) Expression
Time frame: baseline, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Murray, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Interleukin 15 (IL-15) Expression (time frame: baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.