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

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ClinicalTrials.gov Identifier: NCT01687582
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Psoriasis Drug: GLP-1 analog Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement of PASI score [ Time Frame: 4 to 6 months ]

Secondary Outcome Measures :
  1. Evolution of BMI (body mass index) [ Time Frame: 4 to 6 months ]
    number of patients with weight loss

  2. Evolution of immunological data [ Time Frame: 4 to 6 months ]
    cytokines and T cells

  3. Evolution of histopathological data [ Time Frame: 4 to 6 months ]
    thickness, dermis infiltrate in skin plaques and in control areas

  4. Evolution of glycaemic control [ Time Frame: 4 to 6 months ]
    HbA1c

  5. Evolution of routine laboratory measures [ Time Frame: 4 to 6 months ]
    number of participants with biological adverse effects (pancreatitis enzymes)

  6. Evolution of BMI [ Time Frame: 4 to 6 months ]
    weight


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01687582


Locations
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Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Martin Buysschaert, PhD Cliniques universitaires Saint-Luc
More Information
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Publications:

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01687582    
Other Study ID Numbers: UCL-DIAB-02
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
type 2 diabetes
psoriasis
exenatide
liraglutide
Additional relevant MeSH terms:
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Psoriasis
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
 Liraglutide
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Obesity Agents