Role of Interleukin-6 in Exercise

Obesity Clinical Trial

— Exil-6  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073826
• Other study ID #: Donath-1
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: October 31, 2016
• Start date: February 2010
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Sport

Drug:
• Tocilizumab

• Sitagliptin

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	European Foundation for the Study of Diabetes

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon like peptide- 1 (GLP-1)		Change in GLP-1 secretion compared to baseline	No