Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

ConditionsAutonomic Dysfunction Orthostatic Intolerance

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorKansas City Heart Rhythm Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the age of 18 - 85 years

Can provide consent

Negative urine B-hCG

Continued follow-up with the bariatric surgery team.

Disqualifiers

Unable to provide consent

Pregnant or breastfeeding

BMI < 35

Revision surgery of one of the following BS from above

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Development of AD/OI after BS
Other intervention
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.

Treatment groups

400 Participants

are divided into 1 treatment group

Group A: Development of AD/OI after BS.1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kansas City Heart Rhythm Research Foundation

Lead sponsor

Kansas City Heart Rhythm Institute

Collaborator

Bariatric and Metabolic Specialists, Overland Park, KS

Collaborator

Source ClinicalTrials.gov

Apply now