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

This study is currently recruiting participants.
Verified January 2013 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: January 18, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

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 2014
Estimated Primary Completion Date: February 2014 (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
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: January 18, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013