The Effect of Weight Loss on Psoriasis Area Severity Index in Adult Psoriasis Patients

NCT ID: NCT01137448

Last Updated: 2013-12-16

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to evaluate the effect that weight loss has on the severity of psoriasis in obese subjects. Fifty obese (BMI equal to or greater than 30) patients with moderate to severe plaque psoriasis will be enrolled in a weight loss intervention program. The severity of their psoriasis will be reevaluated at month 3 and month 6 of the program to determine what effect weight loss has had on their psoriasis. Serum TNF-alpha will be measured at month 0 and month 6. The hypothesis that will be tested is that weight loss will lead to a significant improvement in the severity of psoriasis and a reduction in TNF-alpha levels.

Detailed Description

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Conditions

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Psoriasis Obesity

Keywords

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Psoriasis Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Weight Loss

Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling.

Group Type EXPERIMENTAL

Weight Loss

Intervention Type BEHAVIORAL

Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.

Interventions

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Weight Loss

Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age
* A Body Mass Index (BMI) \>/= 30
* Subject has plaque psoriasis
* A Psoriasis Area Severity Index (PASI) score \>/= 10 or a total body surface area (BSA) affected by psoriasis \>/= 10%
* Capable of reading, understanding, and signing a consent form
* Females of childbearing potential must have negative urine pregnancy test on Day 0, and agree to a medically effective method of birth control (as determined by the investigator)

Exclusion Criteria

* Already participating in a study for weight loss or a study of other psoriasis treatments
* If they are on systemic therapy for their psoriasis
* Female subjects who are pregnant or planning to become pregnant
* Patients with a history of anorexia nervosa, bulimia, or other diseases that would make a weight loss program a risk to their health
* Subjects unable to comply with study protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Adelaide Hebert

Professor, Director - Pediatric Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adelaide Hebert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical School - Houston

Locations

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University of Texas Dermatology Clinical Research

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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5T35DK007676-18

Identifier Type: NIH

Identifier Source: org_study_id

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