Roles of T Helper 1 Cytokines in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389335
• Other study ID #: MUGEAH-2
• Secondary ID: Interleukins in
• Status: Completed
• Phase: N/A
• First received: March 10, 2015
• Last updated: March 16, 2015
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 ß-cell function and

• insulin sensitivity or anti-inflammatory drugs

• recent history of trauma

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Turkey	Medeniyet University Goztepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes		3 day	No