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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
Development of AD/OI after BS.
  • Other: Development of AD/OI after BS
    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.

Recruiting Locations

Menorah Medical Center
Overland Park, Kansas 66209
Contact:
Donita Atkins

Bariatric and Metabolic Specialists
Overland Park, Kansas 66211
Contact:
Nicole Fearing, MD

Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas 66211
Contact:
Donita Atkins
816-651-1969
Datkins@kchrf.com

Overland Park Regional Medical Center
Overland Park, Kansas 66215
Contact:
Donita Atkins
816-651-1969
datkins@kchrf.com

Centerpoint Medical Center Clinic
Independence, Missouri 64057
Contact:
Donita Atkins

Centerpoint Medical Center
Independence, Missouri 64057
Contact:
Donita Atkins

Research Medical Center Clinic
Kansas City, Missouri 64032
Contact:
Donita Atkins
816-651-1969
Datkins@kchrf.com

Research Medical Center
Kansas City, Missouri 64032
Contact:
Donita Atkins
816-651-1969
Datkins@kchrf.com

More Details

Status
Recruiting
Sponsor
Kansas City Heart Rhythm Research Foundation

Study Contact

Donita Atkins
816-651-1969
datkins@kchrf.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.