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

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Sport
Tocilizumab
Sitagliptin
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Tocilizumab

Sitagliptin

Placebo

Arm Description

Infusion of Tocilizumab and sport intervention

Intake of Sitagliptin and sport intervention

Intake of placebo and sport intervention

Outcomes

Primary Outcome Measures

Glucagon like peptide- 1 (GLP-1)

Secondary Outcome Measures

Full Information

First Posted
October 19, 2009
Last Updated
October 31, 2016
Sponsor
University of Zurich
Collaborators
European Foundation for the Study of Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT01073826
Brief Title
Role of Interleukin-6 in Exercise
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
European Foundation for the Study of Diabetes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab
Arm Type
Active Comparator
Arm Description
Infusion of Tocilizumab and sport intervention
Arm Title
Sitagliptin
Arm Type
Active Comparator
Arm Description
Intake of Sitagliptin and sport intervention
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intake of placebo and sport intervention
Intervention Type
Behavioral
Intervention Name(s)
Sport
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Primary Outcome Measure Information:
Title
Glucagon like peptide- 1 (GLP-1)
Time Frame
Change in GLP-1 secretion compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31796986
Citation
Ellingsgaard H, Seelig E, Timper K, Coslovsky M, Soederlund L, Lyngbaek MP, Wewer Albrechtsen NJ, Schmidt-Trucksass A, Hanssen H, Frey WO, Karstoft K, Pedersen BK, Boni-Schnetzler M, Donath MY. GLP-1 secretion is regulated by IL-6 signalling: a randomised, placebo-controlled study. Diabetologia. 2020 Feb;63(2):362-373. doi: 10.1007/s00125-019-05045-y. Epub 2019 Dec 3.
Results Reference
derived

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Role of Interleukin-6 in Exercise

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