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

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ClinicalTrials.gov Identifier: NCT02860611
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Gonca Incemehmet Tamer, Istanbul Medeniyet University

Brief Summary:

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.


Condition or disease
Type 1 Diabetes Type 2 Diabetes

Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparison of Th1 Cytokine Levels Between Type 1 and Type 2 Diabetes
Study Start Date : February 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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



Primary Outcome Measures :
  1. Difference in T helper cytokines between groups [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Blood


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

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.)

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): NCT02860611


Locations
Turkey
Medeniyet University Goztepe Training and Research Hospital
Istanbul, Turkey, 34730
Sponsors and Collaborators
Istanbul Medeniyet University
Investigators
Principal Investigator: Gonca Tamer Istanbul Medeniyet University

Responsible Party: Gonca Incemehmet Tamer, Assoc. Professor, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT02860611     History of Changes
Other Study ID Numbers: IstanbulMU
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gonca Incemehmet Tamer, Istanbul Medeniyet University:
Type 1 diabetes
Type 2 diabetes
T helper 1 cytokines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases