Effect of Weight Loss on Psoriasis

NCT ID: NCT01137188

Last Updated: 2012-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Low calorie diet

Intervention Type DIETARY_SUPPLEMENT

Low calorie diet containing 800-1000 kcal/day

No intervention

Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Low calorie diet

Low calorie diet containing 800-1000 kcal/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Peter Jensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lone Skov, MD, phd

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital Gentofte, Department of Dermato-venerology

Locations

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Copenhagen University Hospital Gentofte, Department of Dermato-venerology

Hellerup, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 27334236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24556829 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23752669 (View on PubMed)

Other Identifiers

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H-2-2010-001

Identifier Type: -

Identifier Source: org_study_id

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