Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Kansas City Heart Rhythm Research Foundation

Status

Enrolling

Conditions

Orthostatic Intolerance

Autonomic Dysfunction

Treatments

Other: Development of AD/OI after BS

Study type

Observational

Funder types

Other

Identifiers

NCT06289413

KCHRRF_ADiPOSE_0027

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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