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Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Recruiting
18-85 years
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study details
    Autonomic Dysfunction
    Orthostatic Intolerance

NCT06289413

Kansas City Heart Rhythm Research Foundation

7 March 2024

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