Diabetes Mellitus, Type 2Exil-6NCT01073826
Role of Interleukin-6 in Exercise
A study testing Sport, Tocilizumab and Sitagliptin in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Sport, Tocilizumab and Sitagliptin
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Sport, Tocilizumab, Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SportBehavioural
TocilizumabDrug
SitagliptinDrug
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Active comparator | Infusion of Tocilizumab and sport intervention Receives: Behavioral: Sport; Drug: Tocilizumab |
| Sitagliptin | Active comparator | Intake of Sitagliptin and sport intervention Receives: Behavioral: Sport; Drug: Sitagliptin |
| Placebo | Placebo comparator | Intake of placebo and sport intervention Receives: Behavioral: Sport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon like peptide- 1 (GLP-1)
Measured: Change in GLP-1 secretion compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073826
- Sponsor's protocol ID
- Donath-1
- Acronym
- Exil-6
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2009
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31796986
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01073826
- Acronym / sponsor ID
- Exil-6 / Donath-1
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Study start
- Feb 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the role of interleukin-6 during physical activity in patients with type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Active comparator | Behavioral: Sport, Drug: TocilizumabInfusion of Tocilizumab and sport intervention |
| Sitagliptin | Active comparator | Behavioral: Sport, Drug: SitagliptinIntake of Sitagliptin and sport intervention |
| Placebo | Placebo comparator | Behavioral: SportIntake of placebo and sport intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- Anti-diabetic drug other than metformin
- Diabetes duration of more than 5 years
- Inflammatory diseases
- Current infection
- Liver disease (transaminases >2x upper normal range)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sport | Behavioural | Placebo, Sitagliptin, Tocilizumab |
| Tocilizumab | Drug | Tocilizumab |
| Sitagliptin | Drug | Sitagliptin |
Primary outcome
Glucagon like peptide- 1 (GLP-1)
Time frame: Change in GLP-1 secretion compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 31796986Ellingsgaard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sport, Tocilizumab and Sitagliptin in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucagon like peptide- 1 (GLP-1) (time frame: Change in GLP-1 secretion compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.