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Effect of Weight Loss on Psoriasis

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Peter Jensen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01137188
First received: March 18, 2010
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • PASI [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Psoriasis area and severity index

  • PASI [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Psoriasis area severity index

  • PASI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Psoriasis area severity index

  • PASI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Psoriasis area severity index

  • PASI [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Psoriasis area severity index


Secondary Outcome Measures:
  • Risk factors for comorbidity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Risk factors for comorbidity

  • Risk factors for comorbidity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Peter Jensen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01137188     History of Changes
Other Study ID Numbers: H-2-2010-001
Study First Received: March 18, 2010
Last Updated: April 3, 2012
Health Authority: Denmark: De Videnskabsetiske Komiteer for Region Hovedstaden

Additional relevant MeSH terms:
Psoriasis
Weight Loss
Skin Diseases, Papulosquamous
Skin Diseases
 Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013