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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in number of specific immune cells in blood detected by flow cytometry

Time frame: Before and 12 weeks after initiation of liraglutide treatment

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

Zealand Pharma

Registry information

Official study title

Regulation of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide (Victoza)

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 28, 2014
Registry last updated: Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed