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Trial record 4 of 2791 for:    Type 1 Diabetes

Roles of T Helper 1 Cytokines in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02389335
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Type 1 Diabetes

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

Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Roles of Interferon Gamma, Interleukin-2 and Tumor Necrotizan Factor Alpha in the Pathogenesis of Type 1 Diabetes
Study Start Date : April 2013
Primary Completion Date : July 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Roles of interferon gamma, interleukin-2, tumor necrotizan factor alpha in the pathogenesis of type 1 diabetes [ Time Frame: 3 day ]

Biospecimen Retention:   Samples Without DNA
Blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389335


Locations
Turkey
Medeniyet University Goztepe Training and Research Hospital
Istanbul, Turkey, 34730
Sponsors and Collaborators
Istanbul Medeniyet University
More Information

Responsible Party: Gonca Incemehmet Tamer, Assoc prof, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT02389335     History of Changes
Other Study ID Numbers: MUGEAH-2
Interleukins in type 1diabetes ( Registry Identifier: Interleukins )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Gonca Incemehmet Tamer, Istanbul Medeniyet University:
type 1diabetes
IFN γ
IL-2
TNF α

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases