Aggressive Weight Loss Program in Chronic Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531528
• Other study ID #: CECN/134
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: October 29, 2018

Study information

• Verified date: October 2018
• Source: San Giuseppe Moscati Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
Italy	A.O.R.N. "San Giuseppe Moscati"	Avellino

Sponsors (2)

Lead Sponsor	Collaborator
San Giuseppe Moscati Hospital	Policlinico San Matteo Pavia Fondazione IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Psoriasis Area and Severity Index	Change in score (on continuous scale) at the end of study	10 weeks
Secondary	Reduction in Psoriasis Area and Severity Index	Change in score (on continuous scale) at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in Psoriasis Area and Severity Index >=75%	Proportion of patients with change in score >=75% at the end of study	10 weeks
Secondary	Reduction in Psoriasis Area and Severity Index >=75%	Proportion of patients with change in score >=75% at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in Psoriasis Area and Severity Index >=50%	Proportion of patients with change in score >=50% at the end of study	10 weeks
Secondary	Reduction in Psoriasis Area and Severity Index >=50%	Proportion of patients with change in score >=50% at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in body surface area	Change in body surface area (on continuous scale) involved at the end of study	10 weeks
Secondary	Reduction in body surface area	Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in Dermatology Life Quality Index (DLQI)	Change in DLQI (on continuous scale) at the end of study	10 weeks
Secondary	Reduction in Dermatology Life Quality Index (DLQI)	Change in DLQI (on continuous scale) at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in itch severity	Change in itch severity (on continuous visual analogue scale) at the end of study	10 weeks
Secondary	Reduction in itch severity	Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in body weight	Change in body weight (on continuous scale) at the end of study	10 weeks
Secondary	Reduction in body weight	Change in body weight (on continuous scale) at the end of ketogenic diet-phase	4 weeks
Secondary	Reduction in Visceral fat	Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study	10 weeks
Secondary	Reduction in Visceral fat	Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase	4 weeks