CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 400 target
Drug / intervention
Development of AD/OI after BSother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06289413
NCT06289413N/ARecruitingUpdate OverdueUpdated 10mo ago · Completion was 6mo ago
Enrollment Stalled
Update Overdue

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Kansas City Heart Rhythm Research Foundation·observational·Posted Mar 1, 2024·Updated Aug 28, 2025

In Brief

An observational study evaluating Development of AD/OI after BS for Autonomic Dysfunction and Orthostatic Intolerance. Currently recruiting, targeting 400 participants across 8 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ARecruitingOverdue
20252026
First PostedMar 1, 2024
Enrollment StartFeb 12, 2024
Primary CompletionDec 1, 2025
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 2.3 years ago

Interventions

Development of AD/OI after BSother

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.