Back to resultsEffect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Primary Purpose
Type 2 Diabetes, Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
GLP-1 analog
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring type 2 diabetes, psoriasis, exenatide, liraglutide
Eligibility 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
Sites / Locations
- Cliniques universitaires Saint-Luc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GLP-1 analog
Arm Description
Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.
Outcomes
Primary Outcome Measures
Improvement of PASI score
Secondary Outcome Measures
Evolution of BMI (body mass index)
number of patients with weight loss
Evolution of immunological data
cytokines and T cells
Evolution of histopathological data
thickness, dermis infiltrate in skin plaques and in control areas
Evolution of glycaemic control
HbA1c
Evolution of routine laboratory measures
number of participants with biological adverse effects (pancreatitis enzymes)
Evolution of BMI
weight
Full Information
NCT ID
NCT01687582
First Posted
September 11, 2012
Last Updated
March 8, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT01687582
Brief Title
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Official Title
Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Psoriasis
Keywords
type 2 diabetes, psoriasis, exenatide, liraglutide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GLP-1 analog
Arm Type
Experimental
Arm Description
Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day.
Intervention Type
Drug
Intervention Name(s)
GLP-1 analog
Other Intervention Name(s)
Liraglutide, Victoza or Exenatide, Byetta.
Intervention Description
GLP-1 analog treatment
Primary Outcome Measure Information:
Title
Improvement of PASI score
Time Frame
4 to 6 months
Secondary Outcome Measure Information:
Title
Evolution of BMI (body mass index)
Description
number of patients with weight loss
Time Frame
4 to 6 months
Title
Evolution of immunological data
Description
cytokines and T cells
Time Frame
4 to 6 months
Title
Evolution of histopathological data
Description
thickness, dermis infiltrate in skin plaques and in control areas
Time Frame
4 to 6 months
Title
Evolution of glycaemic control
Description
HbA1c
Time Frame
4 to 6 months
Title
Evolution of routine laboratory measures
Description
number of participants with biological adverse effects (pancreatitis enzymes)
Time Frame
4 to 6 months
Title
Evolution of BMI
Description
weight
Time Frame
4 to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Buysschaert, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
22227407
Citation
Buysschaert M, Tennstedt D, Preumont V. Improvement of psoriasis during exenatide treatment in a patient with diabetes. Diabetes Metab. 2012 Feb;38(1):86-8. doi: 10.1016/j.diabet.2011.11.004. Epub 2012 Jan 9.
Results Reference
background
PubMed Identifier
21744074
Citation
Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.
Results Reference
background
Learn more about this trial
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
We'll reach out to this number within 24 hrs