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Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

This study is currently recruiting participants.
Verified September 2012 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor:
Information provided by (Responsible Party):
Buysschaert, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01687582
First received: September 11, 2012
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

The aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog treatment on psoriatic skin lesions in patients with type 2 diabetes.


Condition Intervention
Type 2 Diabetes
Psoriasis
 Drug: GLP-1 analog

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Improvement of PASI score [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of BMI (body mass index) [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    number of patients with weight loss

  • Evolution of immunological data [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    cytokines and T cells

  • Evolution of histopathological data [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    thickness, dermis infiltrate in skin plaques and in control areas

  • Evolution of glycaemic control [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    HbA1c

  • Evolution of routine laboratory measures [ Time Frame: 4 to 6 months ] [ Designated as safety issue: Yes ]
    number of participants with biological adverse effects (pancreatitis enzymes)

  • Evolution of BMI [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
    weight


Estimated Enrollment: 10
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1 analog
Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.
 Drug: GLP-1 analog
GLP-1 analog treatment
Other Name: Liraglutide, Victoza or Exenatide, Byetta.

Detailed Description:

The objective of this study is to analyse short and medium-term efficacy on clinical, immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to severe psoriasis plaques in a group of patients with type 2 diabetes.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin and presenting stable psoriasis plaques for at least one year, which failed to respond to previous systemic and/or topical treatments.

Exclusion Criteria:

  • Type 1 diabetes
  • Secondary diabetes
  • Liver, renal or pancreatic disease
  • Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687582

Contacts
Contact: Martin Buysschaert, PhD +3227645475 martin.buysschaert@uclouvain.be

Locations
Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Martin Buysschaert, PhD     +3227645475     martin.buysschaert@uclouvain.be    
Contact: Vanessa Preumont, MD     +3227645475     vanessa.preumont@uclouvain.be    
Principal Investigator: Martin Buysschaert, PhD            
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Martin Buysschaert, PhD Cliniques universitaires Saint-Luc
  More Information

Publications:

Responsible Party: Buysschaert, Head of Department of Endocrinology, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01687582     History of Changes
Other Study ID Numbers: UCL-DIAB-02
Study First Received: September 11, 2012
Last Updated: September 13, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
type 2 diabetes
psoriasis
exenatide
liraglutide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Psoriasis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Skin Diseases, Papulosquamous
Skin Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013