Effect of Weight Loss on Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low calorie diet
Sponsored by
About this trial
This is an interventional prevention trial for Psoriasis
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
Sites / Locations
- Copenhagen University Hospital Gentofte, Department of Dermato-venerology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
No intervention
Arm Description
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
Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion
Outcomes
Primary Outcome Measures
PASI
Psoriasis area and severity index
PASI
Psoriasis area severity index
PASI
Psoriasis area severity index
PASI
Psoriasis area severity index
PASI
Psoriasis area severity index
Secondary Outcome Measures
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Risk factors for comorbidity
Full Information
NCT ID
NCT01137188
First Posted
March 18, 2010
Last Updated
April 3, 2012
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01137188
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Study subjects will receive routine dietary counseling for 8 weeks and will cross over to intervention upon completion
Intervention Type
Dietary Supplement
Intervention Name(s)
Low calorie diet
Intervention Description
Low calorie diet containing 800-1000 kcal/day
Primary Outcome Measure Information:
Title
PASI
Description
Psoriasis area and severity index
Time Frame
Baseline
Title
PASI
Description
Psoriasis area severity index
Time Frame
4 weeks
Title
PASI
Description
Psoriasis area severity index
Time Frame
8 weeks
Title
PASI
Description
Psoriasis area severity index
Time Frame
12 weeks
Title
PASI
Description
Psoriasis area severity index
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Risk factors for comorbidity
Description
Risk factors for comorbidity
Time Frame
Baseline
Title
Risk factors for comorbidity
Description
Risk factors for comorbidity
Time Frame
4 weeks
Title
Risk factors for comorbidity
Description
Risk factors for comorbidity
Time Frame
8 weeks
Title
Risk factors for comorbidity
Description
Risk factors for comorbidity
Time Frame
12 weeks
Title
Risk factors for comorbidity
Description
Risk factors for comorbidity
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lone Skov, MD, phd
Organizational Affiliation
Copenhagen University Hospital Gentofte, Department of Dermato-venerology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital Gentofte, Department of Dermato-venerology
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27334236
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.
Results Reference
derived
PubMed Identifier
24556829
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.
Results Reference
derived
PubMed Identifier
23752669
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. Erratum In: JAMA Dermatol. 2013 Aug;149(8):997.
Results Reference
derived
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Effect of Weight Loss on Psoriasis
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