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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860611
• Other study ID #: IstanbulMU
• Status: Completed
• Phase: N/A
• First received: August 4, 2016
• Last updated: August 8, 2016
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes
• Type 2 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	Difference in T helper cytokines between groups		6 months	No