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Aggressive Weight Loss Program in Chronic Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diet
Sponsored by
San Giuseppe Moscati Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O.R.N. "San Giuseppe Moscati"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction in Psoriasis Area and Severity Index
Change in score (on continuous scale) at the end of study

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2018
Last Updated
October 29, 2018
Sponsor
San Giuseppe Moscati Hospital
Collaborators
Fondazione IRCCS Policlinico San Matteo di Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT03531528
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Giuseppe Moscati Hospital
Collaborators
Fondazione IRCCS Policlinico San Matteo di Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Diet
Intervention Description
A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
Primary Outcome Measure Information:
Title
Reduction in Psoriasis Area and Severity Index
Description
Change in score (on continuous scale) at the end of study
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Reduction in Psoriasis Area and Severity Index
Description
Change in score (on continuous scale) at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in Psoriasis Area and Severity Index >=75%
Description
Proportion of patients with change in score >=75% at the end of study
Time Frame
10 weeks
Title
Reduction in Psoriasis Area and Severity Index >=75%
Description
Proportion of patients with change in score >=75% at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in Psoriasis Area and Severity Index >=50%
Description
Proportion of patients with change in score >=50% at the end of study
Time Frame
10 weeks
Title
Reduction in Psoriasis Area and Severity Index >=50%
Description
Proportion of patients with change in score >=50% at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in body surface area
Description
Change in body surface area (on continuous scale) involved at the end of study
Time Frame
10 weeks
Title
Reduction in body surface area
Description
Change in body surface area (on continuous scale) involved at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in Dermatology Life Quality Index (DLQI)
Description
Change in DLQI (on continuous scale) at the end of study
Time Frame
10 weeks
Title
Reduction in Dermatology Life Quality Index (DLQI)
Description
Change in DLQI (on continuous scale) at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in itch severity
Description
Change in itch severity (on continuous visual analogue scale) at the end of study
Time Frame
10 weeks
Title
Reduction in itch severity
Description
Change in itch severity (on continuous visual analogue scale) at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in body weight
Description
Change in body weight (on continuous scale) at the end of study
Time Frame
10 weeks
Title
Reduction in body weight
Description
Change in body weight (on continuous scale) at the end of ketogenic diet-phase
Time Frame
4 weeks
Title
Reduction in Visceral fat
Description
Change in aorto-mesenteric fat thickness (on continuous scale) at the end of study
Time Frame
10 weeks
Title
Reduction in Visceral fat
Description
Change in aorto-mesenteric fat thickness (on continuous scale) at the end of ketogenic diet-phase
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Castaldo, MD
Organizational Affiliation
A.O.R.N. "San Giuseppe Moscati", Avellino, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.R.N. "San Giuseppe Moscati"
City
Avellino
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26559897
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.
Results Reference
background
PubMed Identifier
27193396
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.
Results Reference
background
PubMed Identifier
26044613
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.
Results Reference
background
PubMed Identifier
24366220
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.
Results Reference
background

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Aggressive Weight Loss Program in Chronic Plaque Psoriasis

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