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GLP-1 Receptors in Normal Skin and Skin From Patients With Psoriasis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Annesofie Faurschou, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01451905
First Posted: October 14, 2011
Last Update Posted: June 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Annesofie Faurschou, University Hospital, Gentofte, Copenhagen
  Purpose
To examine GLP-1 receptors in skin of psoriasis patients compared with the skin of humans with no skin disease

Condition Intervention
Reduction of Psoriasis Following Liraglutide Therapy in Terms of PASI and DLQI Drug: Liraglutide Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Annesofie Faurschou, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Changes in PASI and DLQI [ Time Frame: 2 months ]

Estimated Enrollment: 12
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psoriasis Drug: Liraglutide
Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylene glycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours.
Placebo Comparator: Placebo Drug: Placebo
The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

4.3 Inclusion Criteria

  • Caucasians above 18 years of age
  • Plaque psoriasis
  • PASI score >10
  • No treatment or stable treatment of psoriasis during at least 3 months before inclusion
  • Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
  • Normal blood pressure
  • Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (~5 times the plasma half-life) 4.4 Exclusion Criteria
  • Psoriasis arthritis
  • Fasting plasma glucose > 7.5 mmol/L or HbA1c > 7.5%
  • Type 1 diabetes
  • Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)
  • Heart failure, NYHA class III-IV
  • Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine >150 µM and/or albuminuria
  • Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) >2 x upper normal serum levels)
  • Anaemia
  • Acute or chronic pancreatitis
  • Struma or thyroid cancer
  • Pregnancy or breast feeding
  • Inability to complete the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451905


Contacts
Contact: Annesofie Faurschou, MD PhD +45 39773977

Locations
Denmark
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Lone Skov, Prof    +45 39773977    losk@geh.regionh.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
  More Information

Responsible Party: Annesofie Faurschou, MD PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01451905     History of Changes
Other Study ID Numbers: GLP1-PSO
First Submitted: October 11, 2011
First Posted: October 14, 2011
Last Update Posted: June 21, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists