Type 1 DiabetesNCT01932476
Gluten Immunity and Islet Autoimmunity in Type-1 Diabetes
A study testing Gluten Challenge in people with Type 1 Diabetes and Celiac Disease, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes, Celiac Disease
- What is being tested?
- Gluten Challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Celiac Disease by histology and serology
- For those with Type-1 Diabetes, at least one anti-islet antibody
- HLA-DQ2.5 genotype
Who cannot join
- Not following a gluten free diet for at least 12 months
- Known gluten exposure within the prior 2 months
- Treatment with systemic immune modifying biological agents (adalimumab, etanercept, infliximab, certolizumab pegol) in prior 6 months
- Treatment with systemic immunomodulatory agents in prior 30 days
- Human immunodeficiency virus infection, untreated hepatitis B virus, or hepatitis C virus infection
- Nut allergy
Show all 12Show fewer
- Hemoglobin level below normal range
- History of angina
- Pregnant or lactating
- Severe symptoms to gluten challenge in the past
- Elevation in transglutaminase-IgA or deamidated gliadin peptide IgA or IgG greater than or equal to 50% above upper limit of normal
- Uncontrolled complications of type-1 diabetes or celiac disease which pose a risk to participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.
Read the detailed description
Participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. This blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.
- Conditions
- Type 1 Diabetes, Celiac Disease
- Being tested
- Gluten Challenge, Sham Challenge
- Medical subject headings
- Diabetes Mellitus, Type 1, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten ChallengeDietary supplement
Three-day gluten containing dietary challenge.
Sham ChallengeDietary supplement
Three-day sham (gluten free) dietary challenge
| Study group | Role | What they receive |
|---|---|---|
| Celiac Disease Alone Gluten Challenge | Experimental | Not described Receives: Dietary Supplement: Gluten Challenge |
| Celiac Disease Alone Sham Challenge | Sham comparator | Not described Receives: Dietary Supplement: Sham Challenge |
| Celiac Disease and T1D Gluten Challenge | Experimental | Not described Receives: Dietary Supplement: Gluten Challenge |
| Celiac Disease and T1D Sham Challenge | Sham comparator | Not described Receives: Dietary Supplement: Sham Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Markers of Autoimmunity
Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.
Measured: Baseline and day 3 post challenge
Secondary outcomes (1)
Gastrointestinal Symptoms
Gastrointestinal symptoms are recorded in a standardized diary at baseline and for 6 days inclusive of challenge.
Measured: Baseline and 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- ImmusanT, Inc.
- Responsible party
- Principal investigator, Jason Gaglia, Joslin Diabetes Center
- Investigators
- Jason Gaglia, MD, MMSc, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932476
- Sponsor's protocol ID
- GC001
- Status last verified
- Apr 2017
- First submitted
- 14 Aug 2013
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Masked Gluten Challenge to Evaluate Markers of Autoimmunity in Patients With Type-1 Diabetes and Celiac Disease After Oral Gluten Challenge
- ClinicalTrials.gov ID
- NCT01932476
- Acronym / sponsor ID
- GC001
- Conditions
- Type 1 Diabetes, Celiac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- ImmusanT, Inc.
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Aug 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.
The purpose of this study is to determine whether the immune response causing celiac disease is related to the autoimmune response causing type-1 diabetes.
Detailed description
Participants meeting eligibility criteria will have blood collected before and after a three-day oral gluten challenge. This blood will be tested for biomarkers associated with islet autoimmunity and gluten-specific cellular immunity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Celiac Disease Alone Gluten Challenge | Experimental | Dietary Supplement: Gluten Challenge |
| Celiac Disease Alone Sham Challenge | Sham comparator | Dietary Supplement: Sham Challenge |
| Celiac Disease and T1D Gluten Challenge | Experimental | Dietary Supplement: Gluten Challenge |
| Celiac Disease and T1D Sham Challenge | Sham comparator | Dietary Supplement: Sham Challenge |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Celiac Disease by histology and serology
- For those with Type-1 Diabetes, at least one anti-islet antibody
- HLA-DQ2.5 genotype
Key exclusion criteria (12 listed)
- Not following a gluten free diet for at least 12 months
- Known gluten exposure within the prior 2 months
- Treatment with systemic immune modifying biological agents (adalimumab, etanercept, infliximab, certolizumab pegol) in prior 6 months
- Treatment with systemic immunomodulatory agents in prior 30 days
- Human immunodeficiency virus infection, untreated hepatitis B virus, or hepatitis C virus infection
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 |
|---|---|---|
| Gluten ChallengeThree-day gluten containing dietary challenge. | Dietary supplement | Celiac Disease Alone Gluten Challenge, Celiac Disease and T1D Gluten Challenge |
| Sham ChallengeThree-day sham (gluten free) dietary challenge | Dietary supplement | Celiac Disease Alone Sham Challenge, Celiac Disease and T1D Sham Challenge |
Primary outcome
Change in Markers of Autoimmunity
Time frame: Baseline and day 3 post challenge
Blood samples for markers of autoimmunity will be taken before and day 3 post challenge.
1 secondary outcome
Gastrointestinal Symptoms
Time frame: Baseline and 6 days
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 17 Apr 2017.
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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.
Jason Gaglia, MD, MMSc principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten Challenge in people with Type 1 Diabetes and Celiac Disease, run by Joslin Diabetes Center 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 12 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 17 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
Change in Markers of Autoimmunity (time frame: Baseline and day 3 post challenge). 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 17 Apr 2017.