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Aggressive Weight Loss Program in Chronic Plaque Psoriasis

NCT ID: NCT03531528

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2018-10-29

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Diet

Intervention Type OTHER

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

Interventions

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Diet

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

San Giuseppe Moscati Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Castaldo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Castaldo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Avellino, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 26559897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27193396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26044613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24366220 (View on PubMed)

Other Identifiers

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CECN/134

Identifier Type: -

Identifier Source: org_study_id