Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160407
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2005-09-08
Brief Title:
Orlistat Xenical in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis NASH
Sponsor:
St Louis University
Organization:
St Louis University
Study Overview
Official Title:
Orlistat Xenical in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis NASH
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if orlistat Xenical therapy in overweight patients with NASH leads to enhanced weight loss over time with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH
Detailed Description:
Previous studies have suggested that steady weight loss over time will result in improvement in aminotransferases and more importantly underlying histopathology in patients with NASH A total of 50 biopsy-proven NASH patients will be enrolled in a prospective randomized fashion Twenty-five patients have been enrolled at the primary study site at Saint Louis University Recruitment of the next 25 patients is taking place at a study subsite at Brooke Army Medical Center in San Antonio Texas
This will be an open-label study comparing an established weight loss program 1400-calorie diet with 30 fat plus daily vitamin E 800 IU and a daily multivitamin to the same weight loss program daily vitamin E 800 IU and multivitamin plus orlistat 120 mg three times daily for 36 weeks
Data to be collected from prospective patients includes demographic information such as age sex past medical history medications height and weight Biochemical data to be collected from prospective patients includes liver enzymes measures of insulin resistance to include insulin levels lipid panel hemoglobin A1C free fatty acids complete blood count coagulation studies and vitamin E levels Blood will also be collected and stored for markers of inflammation and fibrosis such as C reactive protein and TNF-alpha A liver biopsy will be obtained at the completion of the study for both histopathologic analysis and RNA analysis
This will be an open-label study comparing an established weight loss program 1400-calorie diet with 30 fat plus daily vitamin E 800 IU and a daily multivitamin to the same weight loss program daily vitamin E 800 IU and multivitamin plus orlistat 120 mg three times daily for 36 weeks
Data to be collected from prospective patients includes demographic information such as age sex past medical history medications height and weight Biochemical data to be collected from prospective patients includes liver enzymes measures of insulin resistance to include insulin levels lipid panel hemoglobin A1C free fatty acids complete blood count coagulation studies and vitamin E levels Blood will also be collected and stored for markers of inflammation and fibrosis such as C reactive protein and TNF-alpha A liver biopsy will be obtained at the completion of the study for both histopathologic analysis and RNA analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| XEN185 | None | None | None |