Roles of T Helper 1 Cytokines in Type 1 Diabetes

Istanbul Medeniyet University

Status: Completed

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT02389335

Interleukins in type 1diabetes (Registry Identifier)

MUGEAH-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

128 participants in 4 patient groups

Group 1a

Description:

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

Group 1b

Description:

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

Description:

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

Control

Description:

Healthy subjects