Aggressive Weight Loss Program in Chronic Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT03531528
• Recruitment Status: Completed
• First Posted: May 21, 2018
• Last Update Posted: October 31, 2018
• Sponsor: San Giuseppe Moscati Hospital
• Collaborator: Fondazione IRCCS Policlinico San Matteo di Pavia
• Information provided by (Responsible Party): Giuseppe Castaldo, San Giuseppe Moscati Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Other: Diet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 21, 2018
• Actual Primary Completion Date: October 29, 2018
• Actual Study Completion Date: October 29, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental; A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet	Other: Diet; A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet

Outcome Measures

Primary Outcome Measures :

1. Reduction in Psoriasis Area and Severity Index [ Time Frame: 10 weeks ]
   Change in score (on continuous scale) at the end of study

Secondary Outcome Measures :

1. Reduction in Psoriasis Area and Severity Index [ Time Frame: 4 weeks ]
   Change in score (on continuous scale) at the end of ketogenic diet-phase
2. Reduction in Psoriasis Area and Severity Index >=75% [ Time Frame: 10 weeks ]
   Proportion of patients with change in score >=75% at the end of study
3. Reduction in Psoriasis Area and Severity Index >=75% [ Time Frame: 4 weeks ]
   Proportion of patients with change in score >=75% at the end of ketogenic diet-phase
4. Reduction in Psoriasis Area and Severity Index >=50% [ Time Frame: 10 weeks ]
   Proportion of patients with change in score >=50% at the end of study
5. Reduction in Psoriasis Area and Severity Index >=50% [ Time Frame: 4 weeks ]
   Proportion of patients with change in score >=50% at the end of ketogenic diet-phase
6. Reduction in body surface area [ Time Frame: 10 weeks ]
   Change in body surface area (on continuous scale) involved at the end of study
7. Reduction in body surface area [ Time Frame: 4 weeks ]
   Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase
8. Reduction in Dermatology Life Quality Index (DLQI) [ Time Frame: 10 weeks ]
   Change in DLQI (on continuous scale) at the end of study
9. Reduction in Dermatology Life Quality Index (DLQI) [ Time Frame: 4 weeks ]
   Change in DLQI (on continuous scale) at the end of ketogenic diet-phase
10. Reduction in itch severity [ Time Frame: 10 weeks ]
    Change in itch severity (on continuous visual analogue scale) at the end of study
11. Reduction in itch severity [ Time Frame: 4 weeks ]
    Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase
12. Reduction in body weight [ Time Frame: 10 weeks ]
    Change in body weight (on continuous scale) at the end of study
13. Reduction in body weight [ Time Frame: 4 weeks ]
    Change in body weight (on continuous scale) at the end of ketogenic diet-phase
14. Reduction in Visceral fat [ Time Frame: 10 weeks ]
    Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study
15. Reduction in Visceral fat [ Time Frame: 4 weeks ]
    Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

A.O.R.N. "San Giuseppe Moscati"

Avellino, Italy

Sponsors and Collaborators

San Giuseppe Moscati Hospital

Fondazione IRCCS Policlinico San Matteo di Pavia

Investigators

• Principal Investigator: Giuseppe Castaldo, MD; A.O.R.N. "San Giuseppe Moscati", Avellino, Italy

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Giuseppe Castaldo, Principal Investigator, San Giuseppe Moscati Hospital
• ClinicalTrials.gov Identifier: NCT03531528
• Other Study ID Numbers: CECN/134
• First Posted: May 21, 2018
• Last Update Posted: October 31, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psoriasis; Weight Loss; Skin Diseases, Papulosquamous; Skin Diseases; Body Weight Changes; Body Weight