Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide

NCT ID: NCT02201550

Last Updated: 2014-07-28

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

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Liraglutide

Patients with type 2 diabetes undertaking treatment with liraglutide

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* BMI \> 27 kg/m2
* Planed start of treatment with liraglutide
* Age \> 18 years

Exclusion Criteria

* Infection or active inflammatory disorder
* Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids)
* Smoking
* Alcohol consumption \> 14 beverages/week
* Former bariatric surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Zealand Pharma

INDUSTRY

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carsten Dirksen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carsten Dirksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Sten Madsbad, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2012-148-KLB

Identifier Type: -

Identifier Source: org_study_id

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