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NCT Number: NCT06289413

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bariatric and Metabolic Specialists, Overland Park, Kansas, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS)

    Time frame: 3 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Donita Atkins

CONTACT

[email protected]

816-651-1969

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Collaborators

  • Bariatric and Metabolic Specialists, Overland Park, KS
  • Kansas City Heart Rhythm Institute

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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