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

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ClinicalTrials.gov Identifier: NCT01073826
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
European Foundation for the Study of Diabetes
Information provided by (Responsible Party):
University of Zurich

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Obesity Behavioral: Sport Drug: Tocilizumab Drug: Sitagliptin Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Glucagon like peptide- 1 (GLP-1) [ Time Frame: Change in GLP-1 secretion compared to baseline ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01073826


Locations
Switzerland
University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
European Foundation for the Study of Diabetes
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01073826     History of Changes
Other Study ID Numbers: Donath-1
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

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