Obesity, Psoriasis
Conditions
Keywords
Psoriasis, Obesity
Brief summary
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.
Interventions
BEHAVIORALWeight Loss
Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.
Sponsors
National Institutes of Health (NIH)
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of psoriasis | 6 months | The Psoriasis Area Severity Index (PASI) is the most common validated psoriasis severity assessment tool used in clinical trials, and combines redness, thickness, and scaliness of skin lesions with the body surface area that is affected. Most clinical trials define moderate to severe psoriasis as a PASI score of greater than or equal to 10, or a total Body Surface Area (BSA) of greater than or equal to 10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum TNF-alpha levels | 6 months | Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions. |
Countries
United States
Outcome results
None listed