NCT06289413

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Kansas City Heart Rhythm Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

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 4.2%, 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 AD/OI after BS.

Conditions

• Autonomic Dysfunction
• Orthostatic Intolerance

Interventions

Type	Name	Description
OTHER	Development of AD/OI after BS	OI is a type of AD that results in chronic supine-to-standing hypotension and disabling dizziness, lightheadedness, and even syncope. Whether arising from malabsorption, vagus nerve damage, or splanchnic vasodilation, the pathophysiology of OI in bariatric surgery is not clear and requires more investigation. Treatment of OI usually consists of dietary and lifestyle changes, which may include compression stockings and abdominal binders. Medical options include peripheral vasoconstrictors and mineralocorticoids; some patients may be referred to Cardiology for further testing. Management is difficult and endurance and tilt training, inflatable abdominal bands, and beta-blockers have been proposed. One recent study demonstrated the treatment of refractory OI with Droxidopa. Yet, the success of treatment is individualized and necessitates more novel approaches.

Timeline

• Start date: 2024-02-12
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-03-01
• Last updated: 2025-08-28

Locations

8 sites across 1 country: United States