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Recruiting NCT06289413

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

— Observational Autonomic Dysfunction Orthostatic Intolerance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Development of AD/OI after BS.
Who it may be relevant to
Registry conditions: Autonomic Dysfunction, Orthostatic Intolerance. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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

  • 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 mi

Primary outcome measures

  • To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) [Time frame: 3 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 8 centers
  • Menorah Medical Center — Overland Park
  • Bariatric and Metabolic Specialists — Overland Park
  • Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park
  • Overland Park Regional Medical Center — Overland Park
  • Centerpoint Medical Center Clinic — Independence
  • Centerpoint Medical Center — Independence
  • Research Medical Center Clinic — Kansas City
  • Research Medical Center — Kansas City

Publications

  • Lazzati A. Epidemiology of the surgical management of obesity. J Visc Surg. 2023 Apr;160(2S):S3-S6. doi: 10.1016/j.jviscsurg.2022.12.004. Epub 2023 Jan 30. PMID 36725453
  • Arterburn DE, Telem DA, Kushner RF, Courcoulas AP. Benefits and Risks of Bariatric Surgery in Adults: A Review. JAMA. 2020 Sep 1;324(9):879-887. doi: 10.1001/jama.2020.12567. PMID 32870301
  • Zhang JB, Tamboli RA, Albaugh VL, Williams DB, Kilkelly DM, Grijalva CG, Shibao CA. The incidence of orthostatic intolerance after bariatric surgery. Obes Sci Pract. 2019 Dec 6;6(1):76-83. doi: 10.1002/osp4.383. eCollection 2020 Feb. PMID 32128245
  • Rodriguez Ruben, J., et al., AUTONOMIC DYSFUNCTION FOLLOWING BARIATRIC SURGERY. Journal of the American College of Cardiology, 2021. 77(18_Supplement_1): p. 327-327
  • Tanaka H, Yamaguchi H, Tamai H. Treatment of orthostatic intolerance with inflatable abdominal band. Lancet. 1997 Jan 18;349(9046):175. doi: 10.1016/S0140-6736(97)24003-1. No abstract available. PMID 9111544
  • Ector H, Reybrouck T, Heidbuchel H, Gewillig M, Van de Werf F. Tilt training: a new treatment for recurrent neurocardiogenic syncope and severe orthostatic intolerance. Pacing Clin Electrophysiol. 1998 Jan;21(1 Pt 2):193-6. doi: 10.1111/j.1540-8159.1998.tb01087.x. PMID 9474671
  • Freitas J, Santos R, Azevedo E, Costa O, Carvalho M, de Freitas AF. Clinical improvement in patients with orthostatic intolerance after treatment with bisoprolol and fludrocortisone. Clin Auton Res. 2000 Oct;10(5):293-9. doi: 10.1007/BF02281112. PMID 11198485
  • Winker R, Barth A, Bidmon D, Ponocny I, Weber M, Mayr O, Robertson D, Diedrich A, Maier R, Pilger A, Haber P, Rudiger HW. Endurance exercise training in orthostatic intolerance: a randomized, controlled trial. Hypertension. 2005 Mar;45(3):391-8. doi: 10.1161/01.HYP.0000156540.25707.af. Epub 2005 Feb 7. PMID 15699447

Identifiers

NCT: NCT06289413 · KCHRRF_ADiPOSE_0027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗