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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687582
• Other study ID #: UCL-DIAB-02
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Psoriasis
• Type 2 Diabetes

Intervention

Drug:
• GLP-1 analog
GLP-1 analog treatment

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of PASI score		4 to 6 months
Secondary	Evolution of BMI (body mass index)	number of patients with weight loss	4 to 6 months
Secondary	Evolution of immunological data	cytokines and T cells	4 to 6 months
Secondary	Evolution of histopathological data	thickness, dermis infiltrate in skin plaques and in control areas	4 to 6 months
Secondary	Evolution of glycaemic control	HbA1c	4 to 6 months
Secondary	Evolution of routine laboratory measures	number of participants with biological adverse effects (pancreatitis enzymes)	4 to 6 months
Secondary	Evolution of BMI	weight	4 to 6 months