Effect of Weight Loss on Psoriasis

April 3, 2012 updated by: Peter Jensen, University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Copenhagen University Hospital Gentofte, Department of Dermato-venerology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Lone Skov, MD, phd, Copenhagen University Hospital Gentofte, Department of Dermato-venerology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

June 3, 2010

First Posted (Estimate)

June 4, 2010

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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