Autonomic Dysfunction, Orthostatic Intolerance
Conditions
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.
Interventions
OTHERDevelopment 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.
Sponsors
Kansas City Heart and Rhythm Institute, Overland Park, KS
Bariatric and Metabolic Specialists, Overland Park, KS
Kansas City Heart Rhythm Research Foundation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) | 3 Months |
Countries
United States
Contacts
Primary ContactDonita Atkins
Outcome results
None listed