Roles of T Helper 1 Cytokines in Type 1 Diabetes

NCT ID: NCT02389335

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-11-30

Brief Summary

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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

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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

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1a

Patients with type 1 diabetes who have undetectable c-peptide ( ≤0.1 ng/mL) levels after mixed meal tolarance test: group 1a

No interventions assigned to this group

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

No interventions assigned to this group

Group 1c

Patients with type 1 diabetes who have c-peptide levels ≥0.8ng/mL after mixed meal tolerance test: group 1c

No interventions assigned to this group

Control

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients giving consent to participate the study
* Patients with type 1 diabetes according to WHO definiton

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Gonca Incemehmet Tamer

Assoc prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medeniyet University Goztepe Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Interleukins in type 1diabetes

Identifier Type: REGISTRY

Identifier Source: secondary_id

MUGEAH-2

Identifier Type: -

Identifier Source: org_study_id

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