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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02201550
Other study ID # H-2-2012-148-KLB
Secondary ID
Status Completed
Phase N/A
First received July 24, 2014
Last updated July 24, 2014
Start date February 2013
Est. completion date April 2014

Study information

Verified date July 2014
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical 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.

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


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital Zealand Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in number of specific immune cells in blood detected by flow cytometry Before and 12 weeks after initiation of liraglutide treatment No
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