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NCT06289413Recruiting

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Kansas City Heart Rhythm Research Foundation

Start Date

2/12/2024

Completion Date

12/1/2025

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.

Detailed 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 Criteria

Age Range: 18 years to 85 years

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

Interventions

OTHER

Development of AD/OI after BS

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Conditions

Autonomic DysfunctionOrthostatic Intolerance

Locations

Menorah Medical Center

Overland Park, Kansas 66209

United States

Bariatric and Metabolic Specialists

Overland Park, Kansas 66211

United States

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas 66211

United States

Overland Park Regional Medical Center

Overland Park, Kansas 66215

United States

Centerpoint Medical Center Clinic

Independence, Missouri 64057

United States

Centerpoint Medical Center

Independence, Missouri 64057

United States

Research Medical Center Clinic

Kansas City, Missouri 64032

United States

Research Medical Center

Kansas City, Missouri 64032

United States