Type 1 DiabetesNCT02389335
Roles of T Helper 1 Cytokines in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2013to Nov 2014
- 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 included 98 T1DPs and 30 healthy subjects (CG). All subjects were matched on age and gender. β-cell function of 98 T1DPS was assesseed by measuring C-Peptide levels after mixed-meal tolarence test (MMTT)s. T1DPs were divided into 3 groups according to the C-Peptide levels after MMTTs and the groups were as follows: patients with undetectable ≤0.1 ng/mL(group 1a, n=30) C-Peptide levels; minimal 0.1-0.8 ng/mL(group1b, n=30); and sustained ≥0.8ng/mL(group1c, n=38) C-peptide levels which increased at the 90th minute after the meal ≥150% of fasting C-peptide level.
Who may be able to join
- Patients giving consent to participate the study
- Patients with type 1 diabetes according to WHO definiton
Who cannot join
- Acute and chronic inflammatory diseases,
- significant concomitant diseases which may interfere with glucose metabolism
- cancers,
- hemoglobinopathies,
- recently received antibiotics,
- drugs influencing β-cell function and
- insulin sensitivity or anti-inflammatory drugs
- recent history of trauma
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medeniyet University Goztepe Training and Research Hospital
Istanbul, 34730
About this study
Official title: Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes
The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.
Read the detailed description
T helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (T1D). Significant increase in IFN-γ-producing Th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. This data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. We aimed to investigate the relationship between Th1 cytokines (IFN-γ, IL-2 and TNF-α) and T1D and the effect of those cytokines on β-cell function.
- Conditions
- Type 1 Diabetes
- Keywords
- type 1diabetes, IFN γ, IL-2, TNF α
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1a | Patients with type 1 diabetes who have undetectable c-peptide ( ≤0.1 ng/mL) levels after mixed meal tolarance test: group 1a | |
| Group 1b | Patients with type 1 diabetes who have c-peptide levels between 0.1-0.8 ng/mL after mixed meal tolerance test: group 1b | |
| Group 1c | Patients with type 1 diabetes who have c-peptide levels ≥0.8ng/mL after mixed meal tolerance test: group 1c | |
| Control | Healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionNov 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Incemehmet Tamer, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389335
- Sponsor's protocol ID
- MUGEAH-2
- Other IDs
- Interleukins in type 1diabetes
- Status last verified
- Mar 2015
- First submitted
- 10 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02389335
- Acronym / sponsor ID
- MUGEAH-2
- Conditions
- Type 1 Diabetes
- Keywords
- type 1diabetes, IFN γ, IL-2, TNF α
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Mar 2015 (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 mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.
Detailed description
T helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (T1D). Significant increase in IFN-γ-producing Th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. This data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. We aimed to investigate the relationship between Th1 cytokines (IFN-γ, IL-2 and TNF-α) and T1D and the effect of those cytokines on β-cell function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1a | – | –Patients with type 1 diabetes who have undetectable c-peptide ( ≤0.1 ng/mL) levels after mixed meal tolarance test: group 1a |
| Group 1b | – | –Patients with type 1 diabetes who have c-peptide levels between 0.1-0.8 ng/mL after mixed meal tolerance test: group 1b |
| Group 1c | – | –Patients with type 1 diabetes who have c-peptide levels ≥0.8ng/mL after mixed meal tolerance test: group 1c |
| Control | – | –Healthy subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 98 T1DPs and 30 healthy subjects (CG). All subjects were matched on age and gender. β-cell function of 98 T1DPS was assesseed by measuring C-Peptide levels after mixed-meal tolarence test (MMTT)s. T1DPs were divided into 3 groups according to the C-Peptide levels after MMTTs and the groups were as follows: patients with undetectable ≤0.1 ng/mL(group 1a, n=30) C-Peptide levels; minimal 0.1-0.8 ng/mL(group1b, n=30); and sustained ≥0.8ng/mL(group1c, n=38) C-peptide levels which increased at the 90th minute after the meal ≥150% of fasting C-peptide level.
Key inclusion criteria (2 listed)
- Patients giving consent to participate the study
- Patients with type 1 diabetes according to WHO definiton
Key exclusion criteria (8 listed)
- Acute and chronic inflammatory diseases,
- significant concomitant diseases which may interfere with glucose metabolism
- cancers,
- hemoglobinopathies,
- recently received antibiotics,
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
Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes
Time frame: 3 day
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 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 Mar 2015. 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 Turkey (Türkiye). 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?
Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes (time frame: 3 day). 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 Mar 2015.