Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-06-30
2011-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
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
Low calorie diet
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
No interventions assigned to this group
Interventions
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Low calorie diet
Low calorie diet containing 800-1000 kcal/day
Eligibility Criteria
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Inclusion Criteria
* BMI \> 27
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Peter Jensen
MD
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
Countries
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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.
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.
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.
Other Identifiers
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H-2-2010-001
Identifier Type: -
Identifier Source: org_study_id
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