Type 2 Diabetes MellitusNCT02201550
Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide
An observational study of Type 2 Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Apr 2014
- Phase
- Observational
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes undertaking treatment with liraglutide
Who may be able to join
- Type 2 diabetes
- BMI > 27 kg/m2
- Planed start of treatment with liraglutide
- Age > 18 years
Who cannot join
- Infection or active inflammatory disorder
- Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)
- Smoking
- Alcohol consumption > 14 beverages/week
- Former bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide (Victoza)
The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes.
The hypotheses are:
- Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in the blood
- Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood
- Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine profile in the blood
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Patients with type 2 diabetes undertaking treatment with liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of specific immune cells in blood detected by flow cytometry
Measured: Before and 12 weeks after initiation of liraglutide treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startFeb 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand Pharma
- Responsible party
- Principal investigator, Carsten Dirksen, Hvidovre University Hospital
- Investigators
- Carsten Dirksen, MD, PhD, Principal investigator, Hvidovre University HospitalSten Madsbad, MD, DMSc, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201550
- Sponsor's protocol ID
- H-2-2012-148-KLB
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide (Victoza)
- ClinicalTrials.gov ID
- NCT02201550
- Acronym / sponsor ID
- H-2-2012-148-KLB
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Zealand Pharma
- Study start
- Feb 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Jul 2014 (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 this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes.
The hypotheses are:
- Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in the blood
- Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood
- Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine profile in the blood
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | – | –Patients with type 2 diabetes undertaking treatment with liraglutide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes undertaking treatment with liraglutide
Key inclusion criteria (4 listed)
- Type 2 diabetes
- BMI > 27 kg/m2
- Planed start of treatment with liraglutide
- Age > 18 years
Key exclusion criteria (5 listed)
- Infection or active inflammatory disorder
- Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)
- Smoking
- Alcohol consumption > 14 beverages/week
- Former bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in number of specific immune cells in blood detected by flow cytometry
Time frame: Before and 12 weeks after initiation of liraglutide treatment
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 28 Jul 2014.
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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.
Carsten Dirksen, MD, PhD principal investigator
Hvidovre University Hospital
Sten Madsbad, MD, DMSc principal investigator
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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 28 Jul 2014. 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 Denmark. 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. 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?
Change in number of specific immune cells in blood detected by flow cytometry (time frame: Before and 12 weeks after initiation of liraglutide treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2014.