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

Not Applicable

Completed

• Conditions: Psoriasis; Type 2 Diabetes
• Interventions: Drug: GLP-1 analog

• Registration Number: NCT01687582
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-19
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLP-1 analog	GLP-1 analog	Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.

Primary Outcome Measures

Name	Time	Method
Improvement of PASI score	4 to 6 months

Secondary Outcome Measures

Name	Time	Method
Evolution of BMI (body mass index)	4 to 6 months	number of patients with weight loss
Evolution of BMI	4 to 6 months	weight
Evolution of immunological data	4 to 6 months	cytokines and T cells
Evolution of histopathological data	4 to 6 months	thickness, dermis infiltrate in skin plaques and in control areas
Evolution of glycaemic control	4 to 6 months	HbA1c
Evolution of routine laboratory measures	4 to 6 months	number of participants with biological adverse effects (pancreatitis enzymes)

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Belgium