Aggressive Weight Loss Program in Chronic Plaque Psoriasis

Not Applicable

Completed

• Conditions: Psoriasis
• Interventions: Other: Diet

• Registration Number: NCT03531528
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-05-08
• Study Start: 2018-05-21
• Study First Posted: 2018-05-21
• Status Verified: 2018-10
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	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

Name	Time	Method
Reduction in Psoriasis Area and Severity Index	10 weeks	Change in score (on continuous scale) at the end of study

Secondary Outcome Measures

Name	Time	Method
Reduction in body surface area	4 weeks	Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase
Reduction in Psoriasis Area and Severity Index	4 weeks	Change in score (on continuous scale) at the end of ketogenic diet-phase
Reduction in Psoriasis Area and Severity Index >=75%	4 weeks	Proportion of patients with change in score \>=75% at the end of ketogenic diet-phase
Reduction in Psoriasis Area and Severity Index >=50%	4 weeks	Proportion of patients with change in score \>=50% at the end of ketogenic diet-phase
Reduction in Dermatology Life Quality Index (DLQI)	4 weeks	Change in DLQI (on continuous scale) at the end of ketogenic diet-phase
Reduction in itch severity	4 weeks	Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase
Reduction in body weight	4 weeks	Change in body weight (on continuous scale) at the end of ketogenic diet-phase
Reduction in Visceral fat	4 weeks	Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase

Trial Locations

Locations (1)

A.O.R.N. "San Giuseppe Moscati"; 🇮🇹 Avellino, Italy