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

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Weight Loss
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, obesity, body mass index, disease remission, diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    weight loss

    Arm Description

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 31, 2011
    Last Updated
    September 21, 2011
    Sponsor
    Universita di Verona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01439425
    Brief Title
    Weight Reduction Alone May Not be Sufficient to Maintain Disease Remission in Obese Patients With Psoriasis
    Official Title
    Weight Reduction Alone May Not be Sufficient to Maintain Disease Remission in Obese Patients With Psoriasis: a Randomized, Investigator-blinded Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    November 2012 (Anticipated)
    Study Completion Date
    November 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universita di Verona

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Chronic plaque psoriasis is an inflammatory skin disease associated with obesity in 13-34% of cases. In recent years, the prevalence of overweight and obesity has increased in almost all developed countries.Obesity and a high body mass index have been shown to be risk factors for the development of psoriasis and in large, prospective studies obesity precede the development of psoriasis. More recently, obesity in adulthood has been shown to be a risk factor also for psoriatic arthritis. On the other hand, ones psoriasis has been established it may favor behaviors facilitating overweight and obesity. To investigate patients' opinion about their BW, the possibility of dietary approach to psoriasis, a specific questionnaire was administered to 200 consecutive patients with moderate-to-severe chronic plaque psoriasis. In a second part of the study, a 24-week randomized, controlled, investigator-blinded clinical trial was performed on a limited number of patient to see whether hypo-caloric diet to maintain disease remission in obese patients previously treated with methotrexate. Patients were recruited from those consecutively admitted to the psoriasis outpatient clinic of the University Hospital of Verona. The inclusion criteria were: 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. Exclusion criteria were other types of psoriasis (guttate, erythrodermic and pustular psoriasis) and severe obesity (BMI >35). All patients gave their written informed consent before any study-related procedures were performed. All subjects were visited by two dermatologists who recorded demographic, biometrical, and other relevant patient's data. Visits were scheduled at screening, baseline, and every 4 weeks up to 24. Collected data included age, sex, weight, height, BMI, psoriasis duration and concomitant medications. The dermatologist who performed the PASI scoring was unaware of the randomization assignment. Patients stopped methotrexate therapy and were randomly assigned either of two groups: the first group received a low-calorie diet administered by a dietitian (intervention group) whereas the second group did not receive any dietetic recommendation (control group). Randomization was performed with the use of computer-generated random numbers and block size of 4 subjects. Patients underwent clinical and nutritional follow-up every month. 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). Relapses were considered as loss of 50% of PASI improvement score from baseline pre-methotrexate value.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    psoriasis, obesity, body mass index, disease remission, diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    weight loss
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Weight Loss
    Other Intervention Name(s)
    hypo-caloric diet
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    patients' opinion about their body weight and it's relation with psoriasis
    Time Frame
    baseline (0 week)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: other types of psoriasis (guttate, erythrodermic and pustular psoriasis) and severe obesity (BMI >35). exclusion criteria were other types of psoriasis (guttate, erythrodermic and pustular psoriasis) and severe obesity (BMI >35).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Micol Del Giglio, Researcher
    Phone
    +39 045 8122547
    Email
    micol.delgiglio@univr.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Giampiero Girolomoni, Professor
    Organizational Affiliation
    Universita di Verona
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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