Clinical trial NCT03531528: Aggressive Weight Loss Program in Chronic Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: San Giuseppe Moscati Hospital
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2018-05-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in Psoriasis Area and Severity Index
timeFrame: 10 weeks
Secondary outcomes:
measure: Reduction in Psoriasis Area and Severity Index
timeFrame: 4 weeks
measure: Reduction in Psoriasis Area and Severity Index >=75%
timeFrame: 10 weeks
measure: Reduction in Psoriasis Area and Severity Index >=75%
timeFrame: 4 weeks
measure: Reduction in Psoriasis Area and Severity Index >=50%
timeFrame: 10 weeks
measure: Reduction in Psoriasis Area and Severity Index >=50%
timeFrame: 4 weeks
measure: Reduction in body surface area
timeFrame: 10 weeks
measure: Reduction in body surface area
timeFrame: 4 weeks
measure: Reduction in Dermatology Life Quality Index (DLQI)
timeFrame: 10 weeks
measure: Reduction in Dermatology Life Quality Index (DLQI)
timeFrame: 4 weeks
measure: Reduction in itch severity
timeFrame: 10 weeks
measure: Reduction in itch severity
timeFrame: 4 weeks
measure: Reduction in body weight
timeFrame: 10 weeks
measure: Reduction in body weight
timeFrame: 4 weeks
measure: Reduction in Visceral fat
timeFrame: 10 weeks
measure: Reduction in Visceral fat
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: A.O.R.N. "San Giuseppe Moscati"
Study officials:
affiliation: A.O.R.N. "San Giuseppe Moscati", Avellino, Italy
name: Giuseppe Castaldo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castaldo G, Galdo G, Rotondi Aufiero F, Cereda E. Very low-calorie ketogenic diet may allow restoring response to systemic therapy in relapsing plaque psoriasis. Obes Res Clin Pract. 2016 May-Jun;10(3):348-52. doi: 10.1016/j.orcp.2015.10.008. Epub 2015 Nov 11.
citation: Castaldo G, Monaco L, Castaldo L, Galdo G, Cereda E. An observational study of sequential protein-sparing, very low-calorie ketogenic diet (Oloproteic diet) and hypocaloric Mediterranean-like diet for the treatment of obesity. Int J Food Sci Nutr. 2016 Sep;67(6):696-706. doi: 10.1080/09637486.2016.1186157. Epub 2016 May 18.
citation: Castaldo G, Palmieri V, Galdo G, Castaldo L, Molettieri P, Vitale A, Monaco L. Aggressive nutritional strategy in morbid obesity in clinical practice: Safety, feasibility, and effects on metabolic and haemodynamic risk factors. Obes Res Clin Pract. 2016 Mar-Apr;10(2):169-77. doi: 10.1016/j.orcp.2015.05.001. Epub 2015 Jun 1.
citation: Monaco L, Monaco M, Di Tommaso L, Stassano P, Castaldo L, Castaldo G. Aortomesenteric fat thickness with ultrasound predicts metabolic diseases in obese patients. Am J Med Sci. 2014 Jan;347(1):8-13. doi: 10.1097/MAJ.0b013e318288f795.