Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Last updated: October 25, 2024
Sponsor: Kansas City Heart Rhythm Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autonomic Nervous System

Neurologic Disorders

Orthostatic Hypotension

Treatment

Development of AD/OI after BS

Clinical Study ID

NCT06289413
KCHRRF_ADiPOSE_0027
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

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, andbiliopancreatic 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 30days

Exclusion

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 Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Development of AD/OI after BS
Phase:
Study Start date:
February 12, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Bariatric and Metabolic Specialists

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Menorah Medical Center

    Overland Park, Kansas 66209
    United States

    Active - Recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Active - Recruiting

  • Centerpoint Medical Center

    Independence, Missouri 64057
    United States

    Active - Recruiting

  • Centerpoint Medical Center Clinic

    Independence, Missouri 64057
    United States

    Active - Recruiting

  • Research Medical Center

    Kansas City, Missouri 64032
    United States

    Active - Recruiting

  • Research Medical Center Clinic

    Kansas City, Missouri 64032
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.