Role of Interleukin-6 in Exercise (Exil-6)

October 31, 2016 updated by: University of Zurich

A Lifestyle Intervention Study Investigating the Role of Interleukin-6 in the Beneficial Effect of Exercise on Beta-cell Function in Obese People and Patients With Type 2 Diabetes

The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

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

  • Switzerland
      • Zurich, Switzerland
        • University Hospital Zurich

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Obesity group: BMI 30-40 kg/m2, fasting plasma glucose <6.4 mmol/l.
  • Diabetes group: Type 2 diabetes according to American Diabetes Association criteria

Exclusion criteria:

  • Anti-diabetic drug other than metformin
  • Diabetes duration of more than 5 years
  • Inflammatory diseases
  • Current infection
  • Liver disease (transaminases >2x upper normal range)
  • kidney disease (creatinine >1.5 mg/dl for men and 1.4 mg/dl for women)
  • pregnancy or breast-feeding, women of child bearing potential not using an acceptable form of contraception
  • immunosuppressive disease
  • corticosteroid use
  • regular non-steroidal antinflammatory drug usage
  • history of carcinoma
  • history of tuberculosis
  • anemia, bleeding disorders
  • obstructive pulmonary disease.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tocilizumab
Infusion of Tocilizumab and sport intervention
Drug: Tocilizumab
Behavioral: Sport
Active Comparator: Sitagliptin
Intake of Sitagliptin and sport intervention
Drug: Sitagliptin
Behavioral: Sport
Placebo Comparator: Placebo
Intake of placebo and sport intervention
Behavioral: Sport

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucagon like peptide- 1 (GLP-1)
Time Frame: Change in GLP-1 secretion compared to baseline
Change in GLP-1 secretion compared to baseline

Collaborators and Investigators

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

Sponsor

University of Zurich

Collaborators

European Foundation for the Study of Diabetes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2010

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Donath-1

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.

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