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Effect of Weight Loss on Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137188
First Posted: June 4, 2010
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Peter Jensen, University Hospital, Gentofte, Copenhagen
  Purpose

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.


Condition Intervention
Psoriasis Dietary Supplement: Low calorie diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Weight Loss on Skin Manifestations, Inflammatory Markers and Risk Factor for Comorbidity in Obese Patients With Psoriasis - a Randomized Cross-over Study

Resource links provided by NLM:


Further study details as provided by Peter Jensen, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • PASI [ Time Frame: Baseline ]
    Psoriasis area and severity index

  • PASI [ Time Frame: 4 weeks ]
    Psoriasis area severity index

  • PASI [ Time Frame: 8 weeks ]
    Psoriasis area severity index

  • PASI [ Time Frame: 12 weeks ]
    Psoriasis area severity index

  • PASI [ Time Frame: 16 weeks ]
    Psoriasis area severity index


Secondary Outcome Measures:
  • Risk factors for comorbidity [ Time Frame: Baseline ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 4 weeks ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 8 weeks ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 12 weeks ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 16 weeks ]
    Risk factors for comorbidity


Estimated Enrollment: 60
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
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
Low calorie diet containing 800-1000 kcal/day
No Intervention: No intervention
Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137188


Locations
Denmark
Copenhagen University Hospital Gentofte, Department of Dermato-venerology
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
Principal Investigator: Lone Skov, MD, phd Copenhagen University Hospital Gentofte, Department of Dermato-venerology