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The site did not have enough funds to complete study arrengments and start to enrolling. The site was not able to enroll subjects.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight Loss | Experimental | Subjects will be enrolled in a weight loss program and will receive weight loss and nutritional counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss | Behavioral | Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of psoriasis | 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%. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum TNF-alpha levels | Changes in TNF-alpha levels will be correlated to weight loss. TNF-alpha levels assess inflammatory conditions. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adelaide Hebert, MD | University of Texas Medical School - Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Dermatology Clinical Research | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050177 | Overweight |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |