Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289413
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-26
Brief Title:
Autonomic Dysfunction in Patients Following Bariatric Surgery The ADiPOSE Study
Sponsor:
Kansas City Heart Rhythm Research Foundation
Organization:
Kansas City Heart Rhythm Research Foundation
Study Overview
Official Title:
Autonomic Dysfunction in Patients Following Bariatric Surgery The ADiPOSE Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Observational two phase retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction AD in patients who undergo bariatric surgery BS and to better define the underlying pathophysiology of AD following BS
Detailed Description:
Previous studies have investigated the incidence of OI orthostatic intolerance with BS One recent meta-analysis only found a 5-year cumulative incidence of 42 challenging reports of increased incidence However this same study recognized the limited and low-quality evidence investigating this phenomenon Other meta-analyses found only four studies each that matched their search criteria highlighting the lack of evidence Thus this study is designed to investigate the prevalence and better understand ADOI after BS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None