Effect of Weight Loss on Psoriasis

Study Overview
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Brief Summary
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Controlled data show that obesity is a risk factor for psoriasis and that psoriasis severity is correlated with the degree of overweight. No controlled interventional studies reporting on the effect of weight loss on psoriatic skin manifestations have been published and data from case reports are conflicting. Patients with psoriasis demonstrate an increased susceptibility to atherosclerotic comorbidities such as arterial hypertension, coronary vascular disease, stroke, hyperlipidemia and type II diabetes and in severe psoriasis there is an increased risk of early death. Lately the role of inflammation in the atherosclerotic process has been highlighted and the link between psoriasis and atherosclerosis may be explained by the concomitant systemic inflammation in psoriasis. Similarly a state of low level inflammation is seen in obesity where macrophages and adipocytes begin to show overlap in function and gene expression. This leads to an increased migration of macrophages into the adipose tissue and an increased secretion of pro-inflammatory cytokines. In summary, these data and theoretical considerations suggest that weight loss in obese patients with psoriasis may improve skin manifestations and reduce the risk of atherosclerotic comorbidity.

Official Title
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Effect of Weight Loss on Skin Manifestations, Inflammatory Markers and Risk Factor for Comorbidity in Obese Patients With Psoriasis - a Randomized Cross-over Study

Conditions
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Psoriasis

Intervention / Treatment
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* Dietary Supplement: Low calorie diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate/severe psoriasis at inclusion or previous to systemic immunosuppressive therapy BMI > 27 Exclusion Criteria: pregnancy/breast feeding diabetes requiring insulin treatment severe heart/kidney/liver disease gout high potassium intake obesity due to medical conditions/medications use of medical treatment for obesity previous bariatric surgery intentional/unintentional weight loss up to 3 months prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intensive weight loss program and regular group sessions with clinical dietician. Complete dietary substitution with a low calorie diet containing 800-1000 kcal/day for 8 weeks | Dietary Supplement: Low calorie diet<br>* Low calorie diet containing 800-1000 kcal/day<br>|
| No Intervention: No intervention<br>Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI | Psoriasis area and severity index | Baseline | 
| PASI | Psoriasis area severity index | 4 weeks | 
| PASI | Psoriasis area severity index | 8 weeks | 
| PASI | Psoriasis area severity index | 12 weeks | 
| PASI | Psoriasis area severity index | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for comorbidity | Risk factors for comorbidity | Baseline | 
| Risk factors for comorbidity | Risk factors for comorbidity | 4 weeks | 
| Risk factors for comorbidity | Risk factors for comorbidity | 8 weeks | 
| Risk factors for comorbidity | Risk factors for comorbidity | 12 weeks | 
| Risk factors for comorbidity | Risk factors for comorbidity | 16 weeks |