Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Autonomic Dysfunction Clinical Trial

Official title:

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289413
• Other study ID #: KCHRRF_ADiPOSE_0027
• Status: Recruiting
• Start date: March 2024
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Orthostatic Intolerance
• Primary Dysautonomias

Intervention

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.

Locations

Country	Name	City	State
United States	Centerpoint Medical Center	Independence	Missouri
United States	Centerpoint Medical Center Clinic	Independence	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri
United States	Bariatric and Metabolic Specialists	Overland Park	Kansas
United States	Kansas City Heart Rhythm Institute - Roe Clinic	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Bariatric and Metabolic Specialists, Overland Park, KS, Kansas City Heart and Rhythm Institute, Overland Park, KS

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS)		3 Months