Type 2 DiabetesNCT01687582
Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
A study testing GLP-1 analog in people with Type 2 Diabetes and Psoriasis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Psoriasis
- What is being tested?
- GLP-1 analog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Type 1 diabetes
- Secondary diabetes
- Liver, renal or pancreatic disease
- Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Psoriasis
- Being tested
- GLP-1 analog
- Keywords
- type 2 diabetes, psoriasis, exenatide, liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 2, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 analogDrug
Also called Liraglutide, Victoza or Exenatide, Byetta.
GLP-1 analog treatment
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 analog | Experimental | Liraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day. Receives: Drug: GLP-1 analog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of PASI score
Measured: 4 to 6 months
Secondary outcomes (6)
Evolution of BMI (body mass index)
number of patients with weight loss
Measured: 4 to 6 months
Evolution of immunological data
cytokines and T cells
Measured: 4 to 6 months
Evolution of histopathological data
thickness, dermis infiltrate in skin plaques and in control areas
Measured: 4 to 6 months
Evolution of glycaemic control
HbA1c
Measured: 4 to 6 months
Evolution of routine laboratory measures
number of participants with biological adverse effects (pancreatitis enzymes)
Measured: 4 to 6 months
Evolution of BMI
weight
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Buysschaert, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687582
- Sponsor's protocol ID
- UCL-DIAB-02
- Status last verified
- Mar 2019
- First submitted
- 11 Sep 2012
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22227407Hogan 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.
PubMed 21744074
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01687582
- Acronym / sponsor ID
- UCL-DIAB-02
- Conditions
- Type 2 Diabetes, Psoriasis
- Keywords
- type 2 diabetes, psoriasis, exenatide, liraglutide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLP-1 analog | Experimental | Drug: GLP-1 analogLiraglutide, 0.6 to 1.8 mg per day or Exenatide, 5 to 10 µg twice a day. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Type 1 diabetes
- Secondary diabetes
- Liver, renal or pancreatic disease
- Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 analogAlso: Liraglutide, Victoza or Exenatide, Byetta.GLP-1 analog treatment | Drug | GLP-1 analog |
Primary outcome
Improvement of PASI score
Time frame: 4 to 6 months
6 secondary outcomes
Evolution of BMI (body mass index)
Time frame: 4 to 6 months
Evolution of immunological data
Time frame: 4 to 6 months
Evolution of histopathological data
Time frame: 4 to 6 months
Evolution of glycaemic control
Time frame: 4 to 6 months
Evolution of routine laboratory measures
Time frame: 4 to 6 months
Evolution of BMI
Time frame: 4 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Background: PubMed 22227407Buysschaert 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.
- Background: PubMed 21744074Hogan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Buysschaert, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 analog in people with Type 2 Diabetes and Psoriasis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of PASI score (time frame: 4 to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.