Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Kansas City Heart Rhythm Research Foundation
Study ID
NCT06289413
Status
Recruiting
Apply to this trial

Conditions

  • Autonomic Dysfunction
  • Orthostatic Intolerance

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Development of AD/OI after BS — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Development of AD/OI after BS.

Primary Outcome Measure

To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) [ Time Frame: 3 Months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Bariatric and Metabolic SpecialistsOverland ParkKansas66211
Nicole Fearing, MD
Kansas City Heart Rhythm Institute - Roe ClinicOverland ParkKansas66211
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)
Menorah Medical CenterOverland ParkKansas66209
Donita Atkins
Overland Park Regional Medical CenterOverland ParkKansas66215
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni (PRINCIPAL_INVESTIGATOR)
Centerpoint Medical CenterIndependenceMissouri64057
Donita Atkins
Centerpoint Medical Center ClinicIndependenceMissouri64057
Donita Atkins
Research Medical CenterKansas CityMissouri64032
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)
Research Medical Center ClinicKansas CityMissouri64032
Donita Atkins
[email protected]
816-651-1969
Naga Venkata K. Pothineni, MD (PRINCIPAL_INVESTIGATOR)

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Bariatric and Metabolic Specialists· Overland Park, KSKansas City Heart Rhythm Institute - Roe Clinic· Overland Park, KSMenorah Medical Center· Overland Park, KSOverland Park Regional Medical Center· Overland Park, KSCenterpoint Medical Center· Independence, MOCenterpoint Medical Center Clinic· Independence, MO

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