Effect of Weight Loss on Psoriasis

NCT01137188 | Completed

• 1 other identifier: H-2-2010-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (5)

• PASI

  Psoriasis area and severity index

  Baseline

• PASI

  Psoriasis area severity index

  4 weeks

• PASI

  Psoriasis area severity index

  8 weeks

• PASI

  Psoriasis area severity index

  12 weeks

• PASI

  Psoriasis area severity index

  16 weeks

Secondary Outcomes (5)

• Risk factors for comorbidity

  Baseline

• Risk factors for comorbidity

  4 weeks

• Risk factors for comorbidity

  8 weeks

• Risk factors for comorbidity

  12 weeks

• Risk factors for comorbidity

  16 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Dietary Supplement: Low calorie diet

No intervention

NO INTERVENTION

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

Interventions

Low calorie diet DIETARY_SUPPLEMENT

Low calorie diet containing 800-1000 kcal/day

Intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 27

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• University of Copenhagen: collaborator

Study Sites (1)

Copenhagen University Hospital Gentofte, Department of Dermato-venerology

Hellerup, 2900, Denmark

Location

Related Publications (3)

• 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.

  PMID: 27334236 DERIVED

• 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.

  PMID: 24556829 DERIVED

• 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.

  PMID: 23752669 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Lone Skov, MD, phd

  Copenhagen University Hospital Gentofte, Department of Dermato-venerology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: June 4, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

DK (1)