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NCT Number: NCT03531528

Aggressive Weight Loss Program in Chronic Plaque Psoriasis

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.O.R.N. "San Giuseppe Moscati"

Avellino, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet

Primary outcomes

  1. Reduction in Psoriasis Area and Severity Index

    Time frame: 10 weeks

    Change in score (on continuous scale) at the end of study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

San Giuseppe Moscati Hospital

Other

Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 21, 2018
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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