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OpenTrials
Completed

NCT Number: NCT01137188

Effect of Weight Loss on Psoriasis

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital Gentofte, Department of Dermato-venerology

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Low calorie diet

Dietary Supplement

Low calorie diet containing 800-1000 kcal/day

Primary outcomes

  1. PASI

    Time frame: Baseline

    Psoriasis area and severity index

  2. PASI

    Time frame: 4 weeks

    Psoriasis area severity index

  3. PASI

    Time frame: 8 weeks

    Psoriasis area severity index

  4. PASI

    Time frame: 12 weeks

    Psoriasis area severity index

  5. PASI

    Time frame: 16 weeks

    Psoriasis area severity index

Secondary outcomes

  1. Risk factors for comorbidity

    Time frame: Baseline

    Risk factors for comorbidity

  2. Risk factors for comorbidity

    Time frame: 4 weeks

    Risk factors for comorbidity

  3. Risk factors for comorbidity

    Time frame: 8 weeks

    Risk factors for comorbidity

  4. Risk factors for comorbidity

    Time frame: 12 weeks

    Risk factors for comorbidity

  5. Risk factors for comorbidity

    Time frame: 16 weeks

    Risk factors for comorbidity

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 4, 2010
Registry last updated
Apr 4, 2012

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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