Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Kansas City Heart Rhythm Research Foundation400 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Autonomic Dysfunction Orthostatic Intolerance

Interventions

Development of AD/OI after BSOTHER

OI is a type of AD that results in chronic supine-to-standing hypotension and disabling dizziness, lightheadedness, and even syncope. Whether arising from malabsorption, vagus nerve damage, or splanchnic vasodilation, the pathophysiology of OI in bariatric surgery is not clear and requires more investigation. Treatment of OI usually consists of dietary and lifestyle changes, which may include compression stockings and abdominal binders. Medical options include peripheral vasoconstrictors and mineralocorticoids; some patients may be referred to Cardiology for further testing. Management is difficult and endurance and tilt training, inflatable abdominal bands, and beta-blockers have been proposed. One recent study demonstrated the treatment of refractory OI with Droxidopa. Yet, the success of treatment is individualized and necessitates more novel approaches.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (8)

Menorah Medical Center

Overland Park, Kansas, United States

RECRUITING

Bariatric and Metabolic Specialists

Overland Park, Kansas, United States

RECRUITING

Kansas City Heart Rhythm Institute - Roe Clinic

Outcomes

Primary Outcomes

To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS)

Time frame: 3 Months

Central Contacts

Donita Atkins

CONTACT

816-651-1969 datkins@kchrf.com

Data from ClinicalTrials.gov

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