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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Zurich
Sponsor:
Collaborator:
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01073826
First received: October 19, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Diabetes Mellitus, Type 2
Obesity
Behavioral: Sport
Drug: Tocilizumab
Drug: Sitagliptin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Glucagon like peptide- 1 (GLP-1) [ Time Frame: Change in GLP-1 secretion compared to baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: February 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tocilizumab
Infusion of Tocilizumab and sport intervention
Behavioral: Sport Drug: Tocilizumab
Active Comparator: Sitagliptin
Intake of Sitagliptin and sport intervention
Behavioral: Sport Drug: Sitagliptin
Placebo Comparator: Placebo
Intake of placebo and sport intervention
Behavioral: Sport

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073826

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland
Contact: Marc Donath, Prof. Dr.    061 265 25 25    donathm@uhbs.ch   
Sponsors and Collaborators
University of Zurich
European Foundation for the Study of Diabetes
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01073826     History of Changes
Other Study ID Numbers: Donath-1
Study First Received: October 19, 2009
Last Updated: February 10, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014