Clinical trial NCT01137188: Effect of Weight Loss on Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2010-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: PASI
timeFrame: Baseline
measure: PASI
timeFrame: 4 weeks
measure: PASI
timeFrame: 8 weeks
measure: PASI
timeFrame: 12 weeks
measure: PASI
timeFrame: 16 weeks
Secondary outcomes:
measure: Risk factors for comorbidity
timeFrame: Baseline
measure: Risk factors for comorbidity
timeFrame: 4 weeks
measure: Risk factors for comorbidity
timeFrame: 8 weeks
measure: Risk factors for comorbidity
timeFrame: 12 weeks
measure: Risk factors for comorbidity
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Copenhagen University Hospital Gentofte, Department of Dermato-venerology
Study officials:
affiliation: Copenhagen University Hospital Gentofte, Department of Dermato-venerology
name: Lone Skov, MD, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen P, Christensen R, Zachariae C, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Long-term effects of weight reduction on the severity of psoriasis in a cohort derived from a randomized trial: a prospective observational follow-up study. Am J Clin Nutr. 2016 Aug;104(2):259-65. doi: 10.3945/ajcn.115.125849. Epub 2016 Jun 22.
citation: Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Astrup A, Hansen PR, Skov L. Effect of weight loss on the cardiovascular risk profile of obese patients with psoriasis. Acta Derm Venereol. 2014 Nov;94(6):691-4. doi: 10.2340/00015555-1824.
citation: Jensen P, Zachariae C, Christensen R, Geiker NR, Schaadt BK, Stender S, Hansen PR, Astrup A, Skov L. Effect of weight loss on the severity of psoriasis: a randomized clinical study. JAMA Dermatol. 2013 Jul;149(7):795-801. doi: 10.1001/jamadermatol.2013.722.