Clinical trial NCT06289413: Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Official title: Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autonomic Dysfunction
Orthostatic Intolerance
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
Collaborators: name: Kansas City Heart and Rhythm Institute, Overland Park, KS
name: Bariatric and Metabolic Specialists, Overland Park, KS
First posted: 2024-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase I: who have undergone bariatric surgery in the last 3 years. Phase II: who will undergo bariatric surgery within the next 3 months.

Brief 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: 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

Primary outcomes:
measure: To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS)
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Bariatric and Metabolic Specialists
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute - Roe Clinic
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Independence
country: United States
facility: Centerpoint Medical Center Clinic
state: Missouri
city: Independence
country: United States
facility: Centerpoint Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center Clinic
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy
role: PRINCIPAL_INVESTIGATOR
References:
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