Effect of Weight Loss on Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137188
• Other study ID #: H-2-2010-001
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: April 3, 2012
• Start date: June 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: De Videnskabsetiske Komiteer for Region Hovedstaden
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Psoriasis

Intervention

Dietary Supplement:
• Low calorie diet
Low calorie diet containing 800-1000 kcal/day

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Gentofte, Department of Dermato-venerology	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASI	Psoriasis area and severity index	Baseline	No
Primary	PASI	Psoriasis area severity index	4 weeks	No
Primary	PASI	Psoriasis area severity index	8 weeks	No
Primary	PASI	Psoriasis area severity index	12 weeks	No
Primary	PASI	Psoriasis area severity index	16 weeks	No
Secondary	Risk factors for comorbidity	Risk factors for comorbidity	Baseline	No
Secondary	Risk factors for comorbidity	Risk factors for comorbidity	4 weeks	No
Secondary	Risk factors for comorbidity	Risk factors for comorbidity	8 weeks	No
Secondary	Risk factors for comorbidity	Risk factors for comorbidity	12 weeks	No
Secondary	Risk factors for comorbidity	Risk factors for comorbidity	16 weeks	No