Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes

August 8, 2016 updated by: Gonca Incemehmet Tamer, Istanbul Medeniyet University

Recent reports show increased prevalence of obesity in patients with type 1 diabetes (T1DP)s while some studies stated that patients with type 2 diabetes (T2DPs) have islet cell auto-antibodies. These results raise the question of a common pathway in T1DM and T2DM via an association with T helper cells. In this study investigators aimed to investigate the difference between T helper 1 (Th1) cytokines levels in T1DPs, T2DPs and healthy subjects.

The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG).

Serum interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α) levels were measured using ELISA method. Serum levels of those cytokines in T1DPs were compared with those in T2DPs and controls.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34730
        • Medeniyet University Goztepe Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study included 114 T1DPs on insulin treatment, 35 newly diagnosed T2DPs who had not used oral antidiabetics but insulin before and 31 healthy subjects (CG).

Description

Inclusion Criteria:

  • Being >18 years old
  • Giving consent to participate

Exclusion Criteria:

  • Acute and chronic inflammatory diseases
  • significant concomitant disease likely to interfere with glucose metabolism,
  • malignancies,
  • hemoglobinopathies,
  • In addition, glucose intolerance (fasting glucose level and that after glucose load) and HbA1C ≥ 5.7 % were also used exclusion criteria in the control group, group as American Diabetes Association (ADA) defined prediabetes as HbA1C between 5.7-6.4% (Standards of medical care in diabetes -2012. Diabetes care. 2012:35.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy volunteers
Type 1 Diabetes
Patients with type 1 diabetes
Type 2 Diabetes
Patients with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in T helper cytokines between groups
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Investigators

  • Principal Investigator: Gonca Tamer, Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (ESTIMATE)

August 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe