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Autonomic DysfunctionNCT06289413

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

An observational study of Autonomic Dysfunction and Orthostatic Intolerance, run by Kansas City Heart Rhythm Research Foundation at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Development of AD/OI after BS
How many people
400 participants
Where
8 sitesUnited States
Study dates
12 Feb 2024to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

Donita Atkins contact

816-651-1969

datkins@kchrf.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • Centerpoint Medical Center Clinic

    Independence, Missouri, 64057

    Donita Atkins

    Recruiting

  • Centerpoint Medical Center

    Independence, Missouri, 64057

    Donita Atkins

    Recruiting

  • Research Medical Center Clinic

    Kansas City, Missouri, 64032

    Donita Atkins, 816-651-1969, Datkins@kchrf.com

    Naga Venkata K. Pothineni, MD

    Recruiting

  • Research Medical Center

    Kansas City, Missouri, 64032

    Donita Atkins, 816-651-1969, Datkins@kchrf.com

    Naga Venkata K. Pothineni, MD

    Recruiting

  • Menorah Medical Center

    Overland Park, Kansas, 66209

    Donita Atkins

    Recruiting

  • Bariatric and Metabolic Specialists

    Overland Park, Kansas, 66211

    Nicole Fearing, MD

    Recruiting

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas, 66211

    Donita Atkins, 816-651-1969, Datkins@kchrf.com

    Naga Venkata K. Pothineni, MD

    Recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66215

    Donita Atkins, 816-651-1969, datkins@kchrf.com

    Naga Venkata K. Pothineni

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Development of AD/OI after BS
Medical subject headings
Primary Dysautonomias, Orthostatic Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06289413
Study groupRoleWhat they receive
Development of AD/OI after BS.Not described
Receives: Other: Development of AD/OI after BS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start12 Feb 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06289413
Sponsor's protocol ID
KCHRRF_ADiPOSE_0027
Status last verified
Oct 2024
First submitted
26 Feb 2024
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 15699447

  • 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.

    PubMed 35678018

  • 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.

    PubMed 34409762

  • 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.

    PubMed 33655427

  • 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.

    PubMed 35133603

  • 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.

    PubMed 28096259

  • 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.

    PubMed 25561784

  • 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.

    PubMed 30800305

Questions about this trial

What is this clinical trial studying?

An observational study of Autonomic Dysfunction and Orthostatic Intolerance, run by Kansas City Heart Rhythm Research Foundation at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06289413, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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