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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|Eligible Ages||18 Years - 75 Years|
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
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|San Giuseppe Moscati Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Giuseppe Castaldo, MD|
|Principal Investigator Affiliation||A.O.R.N. "San Giuseppe Moscati", Avellino, Italy|
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