NCT06289413

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 28, 2025

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

February 26, 2024

Last Update Submit

August 27, 2025

Conditions

Autonomic DysfunctionOrthostatic Intolerance

Outcome Measures

Primary Outcomes (1)

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

    3 Months

Study Arms (1)

Development of AD/OI after BS.

Other: Development of AD/OI after BS

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.

Development of AD/OI after BS.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Menorah Medical Center

Overland Park, Kansas, 66209, United States

RECRUITING

Bariatric and Metabolic Specialists

Overland Park, Kansas, 66211, United States

RECRUITING

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

RECRUITING

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

RECRUITING

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

RECRUITING

Centerpoint Medical Center

Independence, Missouri, 64057, United States

RECRUITING

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

RECRUITING

Research Medical Center

Kansas City, Missouri, 64032, United States

RECRUITING

Related Publications (18)

  • 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: 36725453BACKGROUND

  • 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: 32870301BACKGROUND

  • 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: 32128245BACKGROUND

  • 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

    BACKGROUND

  • 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: 9111544BACKGROUND

  • 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: 9474671BACKGROUND

  • 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: 11198485BACKGROUND

  • 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: 15699447BACKGROUND

  • Kokorelis C, Bodurtha J, Guthrie K, Rowe PC. Successful Treatment of Refractory Orthostatic Intolerance (OI) With Droxidopa. Clin Pediatr (Phila). 2022 Oct;61(9):593-595. doi: 10.1177/00099228221092645. Epub 2022 Jun 8. No abstract available.

    PMID: 35678018BACKGROUND

  • Al Nou'mani J, Al Alawi AM, Falhammar H, Al Qassabi A. Orthostatic intolerance after bariatric surgery: A systematic review and meta-analysis. Clin Obes. 2021 Dec;11(6):e12483. doi: 10.1111/cob.12483. Epub 2021 Aug 19.

    PMID: 34409762BACKGROUND

  • Kermansaravi M, Chiappetta S, Lainas P, Kassir R. Orthostatic Intolerance after Bariatric Surgery: a Systematic Review. Obes Surg. 2021 May;31(5):2250-2254. doi: 10.1007/s11695-021-05266-4. Epub 2021 Mar 2.

    PMID: 33655427BACKGROUND

  • Addison P, Carsky K, Patti ME, Roslin M. Hypoglycemia and Dysautonomia After Bariatric Surgery: a Systematic Review and Perspective. Obes Surg. 2022 May;32(5):1681-1688. doi: 10.1007/s11695-022-05960-x. Epub 2022 Feb 8.

    PMID: 35133603BACKGROUND

  • Honka H, Koffert J, Kauhanen S, Teuho J, Hurme S, Mari A, Lindqvist A, Wierup N, Groop L, Nuutila P. Bariatric Surgery Enhances Splanchnic Vascular Responses in Patients With Type 2 Diabetes. Diabetes. 2017 Apr;66(4):880-885. doi: 10.2337/db16-0762. Epub 2017 Jan 17.

    PMID: 28096259BACKGROUND

  • Hatipoglu S, Akbulut S, Hatipoglu F, Abdullayev R. Effect of laparoscopic abdominal surgery on splanchnic circulation: historical developments. World J Gastroenterol. 2014 Dec 28;20(48):18165-76. doi: 10.3748/wjg.v20.i48.18165.

    PMID: 25561784BACKGROUND

  • Williams WH 3rd, Browne RC, Bui TP, Holmes AA, Thakar D. Case report on intravenous octreotide for the treatment of intraoperative vasoplegia following thymoma resection. SAGE Open Med Case Rep. 2019 Feb 8;7:2050313X19827744. doi: 10.1177/2050313X19827744. eCollection 2019.

    PMID: 30800305BACKGROUND

  • Chan MM, Chan MM, Mengshol JA, Fish DN, Chan ED. Octreotide: a drug often used in the critical care setting but not well understood. Chest. 2013 Dec;144(6):1937-1945. doi: 10.1378/chest.13-0382.

    PMID: 24297127BACKGROUND

  • Chatila R, Ferayorni L, Gupta T, Groszmann RJ. Local arterial vasoconstriction induced by octreotide in patients with cirrhosis. Hepatology. 2000 Mar;31(3):572-6. doi: 10.1002/hep.510310304.

    PMID: 10706544BACKGROUND

  • Karwa R, Woodis CB. Midodrine and octreotide in treatment of cirrhosis-related hemodynamic complications. Ann Pharmacother. 2009 Apr;43(4):692-9. doi: 10.1345/aph.1L373. Epub 2009 Mar 18.

    PMID: 19299324BACKGROUND

MeSH Terms

Conditions

Primary DysautonomiasOrthostatic Intolerance

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dhanunjaya Lakkireddy

    Kansas City Heart Rhythm Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969datkins@kchrf.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 1, 2024

Study Start

February 12, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 28, 2025

Record last verified: 2024-10

Locations

US(8)