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Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

NCT06289413 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

  • Autonomic Dysfunction
  • Orthostatic Intolerance

Interventions

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.

Sponsors & Collaborators

  • Kansas City Heart and Rhythm Institute, Overland Park, KS

    collaborator UNKNOWN

  • Bariatric and Metabolic Specialists, Overland Park, KS

    collaborator UNKNOWN

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy · Kansas City Heart Rhythm Institute

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289413 on ClinicalTrials.gov