RecruitingNCT06289413

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study


Sponsor

Kansas City Heart Rhythm Research Foundation

Enrollment

400 participants

Start Date

Feb 12, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria7

  • Between the age of 18 - 85 years
  • Can provide consent
  • Negative urine B-hCG
  • Continued follow-up with the bariatric surgery team.
  • BS includes one of the following: gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.
  • Phase I: Underwent BS within the last 3 years
  • Phase II: Will undergo BS within the next 3 months or underwent BS in the last 30 days

Exclusion Criteria7

  • Unable to provide consent
  • Pregnant or breastfeeding
  • BMI < 35
  • Revision surgery of one of the following BS from above
  • Prior history of autonomic dysfunction prior to BS
  • Developed AD 72 months post-procedure
  • No evidence of AD/OI

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Interventions

OTHERDevelopment 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.


Locations(8)

Menorah Medical Center

Overland Park, Kansas, United States

Bariatric and Metabolic Specialists

Overland Park, Kansas, United States

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, United States

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Centerpoint Medical Center Clinic

Independence, Missouri, United States

Centerpoint Medical Center

Independence, Missouri, United States

Research Medical Center Clinic

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States

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NCT06289413


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