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

July 24, 2014 updated by: Carsten Dirksen, Hvidovre University Hospital

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with type 2 diabetes undertaking treatment with liraglutide

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Liraglutide
Patients with type 2 diabetes undertaking treatment with liraglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in number of specific immune cells in blood detected by flow cytometry
Time Frame: Before and 12 weeks after initiation of liraglutide treatment
Before and 12 weeks after initiation of liraglutide treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Zealand Pharma

Investigators

  • Principal Investigator: Carsten Dirksen, MD, PhD, Hvidovre University Hospital
  • Principal Investigator: Sten Madsbad, MD, DMSc, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 24, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2012-148-KLB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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