Role of Interleukin-6 in Exercise
Exil-6
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
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Feb 2010
Longer than P75 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 1, 2016
October 1, 2016
5.8 years
October 19, 2009
October 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Glucagon like peptide- 1 (GLP-1)
Change in GLP-1 secretion compared to baseline
Study Arms (3)
Tocilizumab
ACTIVE COMPARATORInfusion of Tocilizumab and sport intervention
Sitagliptin
ACTIVE COMPARATORIntake of Sitagliptin and sport intervention
Placebo
PLACEBO COMPARATORIntake of placebo and sport intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich
Zurich, Switzerland
Related Publications (1)
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.
PMID: 31796986DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
01 Studienregister MasterAdmins
UniversitaetsSpital Zuerich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2009
First Posted
February 23, 2010
Study Start
February 1, 2010
Primary Completion
November 1, 2015
Study Completion
June 1, 2016
Last Updated
November 1, 2016
Record last verified: 2016-10