Diabetes MellitusNPODNCT03794739
Role of TMEM219 Marker in Type 1 Diabetes
An observational study of Diabetes Mellitus, run by University of Milan at 1 site in Italy.
Trial summary
Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 8 Aug 2020to Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study already approved at the local Ethical Committee provides for the enrollment of the following groups of subjects: * subjects affected by diabetes (type 1, type 2, MODY) * subjects at risk of developing diabetes (positive screening for autoantibodies) * subjects not affected by diabetes Enrollment is coordinated by the University of Florida as part of the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.
Who may be able to join
- Reported in the NPOD protocol
Who cannot join
- Reported in the NPOD protocol
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pediatric Clinical Research Center
Milan, 20157
Paolo Fiorina
About this study
Official title: Ruolo Del Marcatore TMEM219 in Corso di Diabete di Tipo 1
Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. The initial stages of diabetic disease are characterized by the massive and progressive infiltration of T cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. The onset of T1D has been mainly associated to a dysregulation of the immune response. However, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. The investigators have recently shown that the expression of the TMEM219 death factor is an essential factor in controlling the fate of stem cells in diabetes.
The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.
Read the detailed description
METHODS OF RECRUITING THE SUBJECTS Healthy subjects, individuals with type 1 and type 2 diabetes and those who are at risk of developing diabetes will be enrolled. Enrollment was approved by the University of Florida Ethics Committee within the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.
Duration of the study: 5 years.
EXPERIMENTAL PROCEDURE:
The following analyses will be performed on the collected and received samples:
- Study of TMEM219 expression and of other TMEM219-related markers by immunohistochemistry and immunofluorescence and western blot
- Study of TMEM219 expression and of other TMEM219-related markers by molecular biology analysis
- Analysis of the proteomic profile on collected biological liquids The above analyses will be performed at the Pediatric Clinical Research Center Romeo ed Enrica Invernizzi at the Sacco Hospital - University of Milan.
PREVIOUS EXPERIENCES The investigatore expertise in manipulating / studying the signaling involved in the pathogenesis of type 1 diabetes has been widely recognized in several publications in recent years (Diabetes 2013, Diabetes 2014, Diabetes 2015, Science Translational Medicine 2017) as well as the characterization of marker expression including TMEM219 (Cell Stem Cell 2015).
RELEVANCE OF THE STUDY The study offers the possibility to acquire new information on the pathogenesis of diabetes and to identify new target mechanisms for designing innovative therapeutic strategies in the treatment of diabetes.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Beta cell loss, Beta cell apoptosis
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects without diabetes, no recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. | |
| T1D individuals | Type 1 diabetic individuals with at least 3-year of duration of the disease. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. | |
| T2D individuals | Type 2 diabetic individuals with at least 5-year duration of the disease. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. | |
| AutoAb+ individuals | Individuals at risk for type 1 diabetes, with one or more autoantibody detected. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered TMEM219 expression in pancreatic islets/beta cells in diabetes.
Change of TMEM219 expression in pancreatic islets/beta cells of healthy subjects as compared to that of individuals with type 1 diabetes (T1D), with type 2 diabetes (T2D) and of those at risk for developing the disease.
Measured: 1-24 months
Secondary outcomes (2)
Increased beta cell loss due to a dysregulated TMEM219 signaling in diabetes.
Change in TMEM219-related factors and signaling in pancreatic islets/beta cells of healthy subjects as compared to individuals with T1D, with T2D and of individuals at risk for developing the disease.
Measured: 25 months-48 months
Altered TMEM219-peripheral regulating factors in diabetes.
Change of peripheral factors involved in controlling TMEM219 expression/activation detected in the serum of healthy subjects as compared to individuals with T1D, with T2D and at risk for developing the disease.
Measured: 49 months-60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start8 Aug 2020
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Fiorina, MD, University of Milan
- Investigators
- Paolo Fiorina, MD, PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794739
- Sponsor's protocol ID
- 2018/ST/080
- Acronym
- NPOD
- Status last verified
- May 2023
- First submitted
- 31 Dec 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruolo Del Marcatore TMEM219 in Corso di Diabete di Tipo 1
- ClinicalTrials.gov ID
- NCT03794739
- Acronym / sponsor ID
- NPOD / 2018/ST/080
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Beta cell loss, Beta cell apoptosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Jan 2019 (actual)
- 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.
Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. The initial stages of diabetic disease are characterized by the massive and progressive infiltration of T cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. The onset of T1D has been mainly associated to a dysregulation of the immune response. However, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. The investigators have recently shown that the expression of the TMEM219 death factor is an essential factor in controlling the fate of stem cells in diabetes.
The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.
Detailed description
METHODS OF RECRUITING THE SUBJECTS Healthy subjects, individuals with type 1 and type 2 diabetes and those who are at risk of developing diabetes will be enrolled. Enrollment was approved by the University of Florida Ethics Committee within the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.
Duration of the study: 5 years.
EXPERIMENTAL PROCEDURE:
The following analyses will be performed on the collected and received samples:
- Study of TMEM219 expression and of other TMEM219-related markers by immunohistochemistry and immunofluorescence and western blot
- Study of TMEM219 expression and of other TMEM219-related markers by molecular biology analysis
- Analysis of the proteomic profile on collected biological liquids The above analyses will be performed at the Pediatric Clinical Research Center Romeo ed Enrica Invernizzi at the Sacco Hospital - University of Milan.
PREVIOUS EXPERIENCES The investigatore expertise in manipulating / studying the signaling involved in the pathogenesis of type 1 diabetes has been widely recognized in several publications in recent years (Diabetes 2013, Diabetes 2014, Diabetes 2015, Science Translational Medicine 2017) as well as the characterization of marker expression including TMEM219 (Cell Stem Cell 2015).
RELEVANCE OF THE STUDY The study offers the possibility to acquire new information on the pathogenesis of diabetes and to identify new target mechanisms for designing innovative therapeutic strategies in the treatment of diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –Healthy subjects without diabetes, no recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. |
| T1D individuals | – | –Type 1 diabetic individuals with at least 3-year of duration of the disease. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. |
| T2D individuals | – | –Type 2 diabetic individuals with at least 5-year duration of the disease. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. |
| AutoAb+ individuals | – | –Individuals at risk for type 1 diabetes, with one or more autoantibody detected. No recent surgery interventions, no malignancies no pregnancy. No intervention. No age limit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study already approved at the local Ethical Committee provides for the enrollment of the following groups of subjects: * subjects affected by diabetes (type 1, type 2, MODY) * subjects at risk of developing diabetes (positive screening for autoantibodies) * subjects not affected by diabetes Enrollment is coordinated by the University of Florida as part of the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.
Key inclusion criteria (1 listed)
- Reported in the NPOD protocol
Key exclusion criteria (1 listed)
- Reported in the NPOD protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Altered TMEM219 expression in pancreatic islets/beta cells in diabetes.
Time frame: 1-24 months
Change of TMEM219 expression in pancreatic islets/beta cells of healthy subjects as compared to that of individuals with type 1 diabetes (T1D), with type 2 diabetes (T2D) and of those at risk for developing the disease.
2 secondary outcomes
Increased beta cell loss due to a dysregulated TMEM219 signaling in diabetes.
Time frame: 25 months-48 months
Altered TMEM219-peripheral regulating factors in diabetes.
Time frame: 49 months-60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Paolo Fiorina, MD, PhD principal investigator
University of Milan
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 Diabetes Mellitus, run by University of Milan at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca D'Addio, MD,PhD (+390250319820, francesca.daddio@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered TMEM219 expression in pancreatic islets/beta cells in diabetes. (time frame: 1-24 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 10 May 2023.