Weight Reduction Alone May Not be Sufficient to Maintain Disease Remission in Obese Patients With Psoriasis

NCT01439425 | Unknown Phase 4

• 1 other identifier: WRP
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The relative risk of psoriasis and its severity are directly related to the body mass index (BMI).Patients with psoriasis likely undergo a vicious circle where obesity and skin disease reinforce each other. To investigate patients' opinion about their body weight (BW), the possibility of dietary approach to psoriasis, and to examine the adherence and the effects of hypo-energetic diet to maintain disease remission in obese patients a dedicated questionnaire was administered to 200 consecutive patients (125 men and 75 women) with moderate-to-severe chronic plaque psoriasis investigating whether diet factors could influence psoriasis severity and course. In second part of study, obese patients with psoriasis in remission (PASI improvement ≥ 75%) for at least 12 weeks after methotrexate therapy were randomly assigned to receive a hypo-caloric diet or free diet for 24 weeks, and then followed up for additional 12 weeks.

Conditions

Psoriasis

Keywords

psoriasis; obesity; body mass index; disease remission; diet

Outcome Measures

Primary Outcomes (1)

• difference in PASI at week 24 between obese psoriatic patients who underwent hypocaloric diet compared to those in free diet after obtaining a PASI reduction >75 following methotrexate.

  24 weeks

Secondary Outcomes (1)

• patients' opinion about their body weight and it's relation with psoriasis

  baseline (0 week)

Study Arms (1)

weight loss

EXPERIMENTAL

balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range: 1200-1500 kcal/d for women, 1300-1600 kcal/d for men).

Behavioral: Weight Loss

Interventions

Weight Loss BEHAVIORAL

The low-calorie diet was designed to achieve a loss of 5-10% of initial body weight. The caloric restriction was 500 kcal below the resting energy expenditure, as evaluated by the Harris-Benedict equation. Intervention group patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range: 1200-1500 kcal/d for women, 1300-1600 kcal/d for men).

Also known as: hypo-caloric diet

weight loss

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients ≥ 18 year of age with moderate to severe psoriasis and a BMI ≥ 30 and without psoriasis arthritis, who were treated with methotrexate and had obtained a reduction in psoriasis severity of at least 75% (PASI 75) for the 12 weeks before enrolling into the study.
• all patients gave their written informed consent before any study-related procedures were performed.

You may not qualify if:

• other types of psoriasis (guttate, erythrodermic and pustular psoriasis) and severe obesity (BMI \>35).

Sponsors & Collaborators

• Universita di Verona: lead

MeSH Terms

Conditions

Psoriasis; Obesity

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giampiero Girolomoni, Professor

  Universita di Verona

  STUDY CHAIR

Central Study Contacts

Micol Del Giglio, Researcher

CONTACT

+39 045 8122547; micol.delgiglio@univr.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resercher

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 23, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 23, 2011

Record last verified: 2011-09