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Aggressive Weight Loss Program in Chronic Plaque Psoriasis

Study Purpose

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 Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03531528

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
San Giuseppe Moscati Hospital

The person who is responsible for the scientific and technical direction of the entire clinical study.

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

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Psoriasis

Contact a Trial Team

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International Sites

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

Status

Recruiting

Address

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

Avellino, ,

Site Contact

Giuseppe Castaldo, MD

lavoronep@yahoo.it

00390825203358

Nearest Location

Site Contact

Giuseppe Castaldo, MD

lavoronep@yahoo.it

00390825203358

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