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Aggressive Weight Loss Program in Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03531528
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Policlinico San Matteo Pavia Fondazione IRCCS
Information provided by (Responsible Party):
Giuseppe Castaldo, San Giuseppe Moscati Hospital

Brief Summary:
Chronic plaque psoriasis is frequently associated with obesity and previous studies have shown that a calorie-controlled diet inducing body weight loss improves symptoms and increases the response to pharmacologic treatment. Besides, clinical improvement has been directly correlated with the amount of weight loss. Short-term very low-calorie ketogenic diets are responsible for substantial weight loss and attenuate systemic inflammation to a higher extent than moderately hypocaloric diets. This intervention has been recently demonstrated to restore, after only 4 week, the response to biological therapy in a patient suffering from relapsing moderate-to-severe plaque psoriasis and obesity-related metabolic syndrome. We investigated the efficacy of an aggressive weight loss program with a ketogenic induction phase in a single-arm trial that could provide the rationale for a large randomized trial.

Condition or disease Intervention/treatment Phase
Psoriasis Other: Diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm Trial to Evaluate the Efficacy of an Aggressive Weight Loss Program With a Ketogenic Induction Phase for the Treatment of Chronic Plaque Psoriasis
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Other: Diet
A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet




Primary Outcome Measures :
  1. Reduction in Psoriasis Area and Severity Index [ Time Frame: 10 weeks ]
    Change in score (on continuous scale) at the end of study


Secondary Outcome Measures :
  1. Reduction in Psoriasis Area and Severity Index [ Time Frame: 4 weeks ]
    Change in score (on continuous scale) at the end of ketogenic diet-phase

  2. Reduction in Psoriasis Area and Severity Index >=75% [ Time Frame: 10 weeks ]
    Proportion of patients with change in score >=75% at the end of study

  3. Reduction in Psoriasis Area and Severity Index >=75% [ Time Frame: 4 weeks ]
    Proportion of patients with change in score >=75% at the end of ketogenic diet-phase

  4. Reduction in Psoriasis Area and Severity Index >=50% [ Time Frame: 10 weeks ]
    Proportion of patients with change in score >=50% at the end of study

  5. Reduction in Psoriasis Area and Severity Index >=50% [ Time Frame: 4 weeks ]
    Proportion of patients with change in score >=50% at the end of ketogenic diet-phase

  6. Reduction in body surface area [ Time Frame: 10 weeks ]
    Change in body surface area (on continuous scale) involved at the end of study

  7. Reduction in body surface area [ Time Frame: 4 weeks ]
    Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase

  8. Reduction in Dermatology Life Quality Index (DLQI) [ Time Frame: 10 weeks ]
    Change in DLQI (on continuous scale) at the end of study

  9. Reduction in Dermatology Life Quality Index (DLQI) [ Time Frame: 4 weeks ]
    Change in DLQI (on continuous scale) at the end of ketogenic diet-phase

  10. Reduction in itch severity [ Time Frame: 10 weeks ]
    Change in itch severity (on continuous visual analogue scale) at the end of study

  11. Reduction in itch severity [ Time Frame: 4 weeks ]
    Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase

  12. Reduction in body weight [ Time Frame: 10 weeks ]
    Change in body weight (on continuous scale) at the end of study

  13. Reduction in body weight [ Time Frame: 4 weeks ]
    Change in body weight (on continuous scale) at the end of ketogenic diet-phase

  14. Reduction in Visceral fat [ Time Frame: 10 weeks ]
    Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study

  15. Reduction in Visceral fat [ Time Frame: 4 weeks ]
    Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable chronic plaque psoriasis
  • Overweight/obese (body mass index >25 kg/m2)

Exclusion Criteria:

  • pregnancy and/or lactation
  • insulin-dependent diabetes mellitus
  • a psychiatric disorder
  • current or previous (<1 year since last chemo- or radiotherapy) neoplastic disease
  • established vascular disease
  • recent (6 months), history of diet-induced or unintentional weight loss
  • moderate-to-severe heart failure
  • arrhythmia or conduction disorder
  • renal failure (creatinine >1.5 mg/dL)
  • liver failure (Child-Pugh ≥ A)
  • any type of gastrointestinal disease
  • moderate-severe hypoalbuminemia (<3.0 g/dL)
  • altered serum electrolytes
  • refusal to give written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531528


Locations
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Italy
A.O.R.N. "San Giuseppe Moscati"
Avellino, Italy
Sponsors and Collaborators
San Giuseppe Moscati Hospital
Policlinico San Matteo Pavia Fondazione IRCCS
Investigators
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Principal Investigator: Giuseppe Castaldo, MD A.O.R.N. "San Giuseppe Moscati", Avellino, Italy

Publications:
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Responsible Party: Giuseppe Castaldo, Principal Investigator, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier: NCT03531528     History of Changes
Other Study ID Numbers: CECN/134
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Weight Loss
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms