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Completed

NCT Number: NCT01687582

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1 analog

Drug

GLP-1 analog treatment

Other names: Liraglutide, Victoza or Exenatide, Byetta.

Primary outcomes

  1. Improvement of PASI score

    Time frame: 4 to 6 months

Secondary outcomes

  1. Evolution of BMI (body mass index)

    Time frame: 4 to 6 months

    number of patients with weight loss

  2. Evolution of immunological data

    Time frame: 4 to 6 months

    cytokines and T cells

  3. Evolution of histopathological data

    Time frame: 4 to 6 months

    thickness, dermis infiltrate in skin plaques and in control areas

  4. Evolution of glycaemic control

    Time frame: 4 to 6 months

    HbA1c

  5. Evolution of routine laboratory measures

    Time frame: 4 to 6 months

    number of participants with biological adverse effects (pancreatitis enzymes)

  6. Evolution of BMI

    Time frame: 4 to 6 months

    weight

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 19, 2012
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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