Role of Interleukin-6 in Exercise

NCT ID: NCT01073826

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tocilizumab

Infusion of Tocilizumab and sport intervention

Group Type ACTIVE_COMPARATOR

Sport

Intervention Type BEHAVIORAL

Tocilizumab

Intervention Type DRUG

Sitagliptin

Intake of Sitagliptin and sport intervention

Group Type ACTIVE_COMPARATOR

Sport

Intervention Type BEHAVIORAL

Sitagliptin

Intervention Type DRUG

Placebo

Intake of placebo and sport intervention

Group Type PLACEBO_COMPARATOR

Sport

Intervention Type BEHAVIORAL

Interventions

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Sport

Intervention Type BEHAVIORAL

Tocilizumab

Intervention Type DRUG

Sitagliptin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Foundation for the Study of Diabetes

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 31796986 (View on PubMed)

Other Identifiers

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Donath-1

Identifier Type: -

Identifier Source: org_study_id