Aggressive Weight Loss Program in Chronic Plaque Psoriasis

San Giuseppe Moscati Hospital

Status

Completed

Conditions

Psoriasis

Treatments

Other: Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03531528

CECN/134

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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