Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
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.
|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|
- Improvement of PASI score [ Time Frame: 4 to 6 months ] [ Designated as safety issue: No ]
- 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
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687582
|Contact: Martin Buysschaert, PhDfirstname.lastname@example.org|
|Cliniques universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Martin Buysschaert, PhD +3227645475 email@example.com|
|Contact: Vanessa Preumont, MD +3227645475 firstname.lastname@example.org|
|Principal Investigator: Martin Buysschaert, PhD|
|Principal Investigator:||Martin Buysschaert, PhD||Cliniques universitaires Saint-Luc|