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

March 8, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Clinical and Histopathological 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Liraglutide, Victoza or Exenatide, Byetta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of PASI score
Time Frame: 4 to 6 months
4 to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Martin Buysschaert, PhD, Cliniques Universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL-DIAB-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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