Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Phase

N/A

Condition

Autonomic Nervous System

Orthostatic Hypotension

Neurologic Disorders

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

Development of AD/OI after BS

February 12, 2024

December 31, 2025

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
Site Not Available
Bariatric and Metabolic Specialists
Overland Park 4276873, Kansas 4273857 66211
United States
Active - Recruiting
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park 4276873, Kansas 4273857 66211
United States
Active - Recruiting
Menorah Medical Center
Overland Park 4276873, Kansas 4273857 66209
United States
Active - Recruiting
Overland Park Regional Medical Center
Overland Park 4276873, Kansas 4273857 66215
United States
Active - Recruiting
Centerpoint Medical Center
Independence, Missouri 64057
United States
Active - Recruiting
Centerpoint Medical Center Clinic
Independence, Missouri 64057
United States
Site Not Available
Research Medical Center
Kansas City, Missouri 64032
United States
Site Not Available
Research Medical Center Clinic
Kansas City, Missouri 64032
United States
Active - Recruiting
Centerpoint Medical Center
Independence 4391812, Missouri 4398678 64057
United States
Active - Recruiting
Centerpoint Medical Center Clinic
Independence 4391812, Missouri 4398678 64057
United States
Active - Recruiting
Research Medical Center
Kansas City 4393217, Missouri 4398678 64032
United States
Active - Recruiting
Research Medical Center Clinic
Kansas City 4393217, Missouri 4398678 64032
United States
Active - Recruiting

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