Epidemiology of the surgical management of obesity.
A Lazzati
https://pubmed.ncbi.nlm.nih.gov/36725453Actively Recruiting
Age: 18Years - 85Years
All Genders
ID06289413
Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2025-08-28
400
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kansas City Heart Rhythm Research Foundation
Lead Sponsor
K
Kansas City Heart Rhythm Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating autonomic dysfunction (AD) and orthostatic intolerance (OI) in patients who have undergone bariatric surgery (BS). This observational study aims to assess how common AD is after BS and to better understand the underlying causes and outcomes. Previous research has shown limited and low-quality evidence on this topic, prompting this study to improve knowledge about AD/OI following bariatric procedures. The study includes both retrospective and prospective phases. Patients who have had BS within the last 3 years or will undergo BS soon are observed to characterize the development of AD/OI after surgery. Bariatric surgeries studied include gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch. The study does not involve any experimental treatments but focuses on monitoring and collecting data about AD/OI symptoms and progression. Participants will provide consent and maintain follow-up with their bariatric surgery team. Researchers will evaluate the prevalence and outcomes of autonomic dysfunction at around 3 months after surgery. Data collection includes medical history, symptom tracking, and follow-up evaluations to better define AD/OI characteristics. The study will end in December 2025, allowing for thorough observation and outcome assessment over time.
CONDITIONS
Brief Title
Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Between the age of 18 - 85 years
- Able to provide consent
- Negative urine B-hCG test
- Continued follow-up with the bariatric surgery team
- Underwent bariatric surgery including gastric bypass, sleeve gastrectomy, or biliopancreatic diversion with duodenal switch
- Phase I: Had bariatric surgery within the last 3 years
- Phase II: Will undergo bariatric surgery within the next 3 months or had surgery in the last 30 days
You will not qualify if you...
- Unable to provide consent
- Pregnant or breastfeeding
- Body mass index (BMI) less than 35
- Revision surgery of bariatric procedures listed
- History of autonomic dysfunction prior to bariatric surgery
- Developed autonomic dysfunction more than 72 months after surgery
- No evidence of autonomic dysfunction or orthostatic intolerance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surveillance
Duration - 3 months
Participants who underwent bariatric surgery are observed to assess the prevalence and characteristics of autonomic dysfunction and orthostatic intolerance after surgery.
1 to 2 visits depending on timing relative to surgery
Trial Site Locations
Total: 8 locations
1
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Actively Recruiting
2
Bariatric and Metabolic Specialists
Overland Park, Kansas, United States, 66211
Actively Recruiting
3
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211
Actively Recruiting
4
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66215
Actively Recruiting
5
Centerpoint Medical Center Clinic
Independence, Missouri, United States, 64057
Actively Recruiting
6
Centerpoint Medical Center
Independence, Missouri, United States, 64057
Actively Recruiting
7
Research Medical Center Clinic
Kansas City, Missouri, United States, 64032
Actively Recruiting
8
Research Medical Center
Kansas City, Missouri, United States, 64032
Actively Recruiting
Loading map...
Research Team
D
Donita Atkins
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Benefits and Risks of Bariatric Surgery in Adults: A Review.
David E Arterburn, Dana A Telem, Robert F Kushner...
https://pubmed.ncbi.nlm.nih.gov/32870301The incidence of orthostatic intolerance after bariatric surgery.
James B Zhang, Robyn A Tamboli, Vance L Albaugh...
https://pubmed.ncbi.nlm.nih.gov/32128245Treatment of orthostatic intolerance with inflatable abdominal band.
H Tanaka, H Yamaguchi, H Tamai
https://pubmed.ncbi.nlm.nih.gov/9111544Tilt training: a new treatment for recurrent neurocardiogenic syncope and severe orthostatic intolerance.
H Ector, T Reybrouck, H Heidbüchel...
https://pubmed.ncbi.nlm.nih.gov/9474671Clinical improvement in patients with orthostatic intolerance after treatment with bisoprolol and fludrocortisone.
J Freitas, R Santos, E Azevedo...
https://pubmed.ncbi.nlm.nih.gov/11198485Endurance exercise training in orthostatic intolerance: a randomized, controlled trial.
Robert Winker, Alfred Barth, Daniela Bidmon...
https://pubmed.ncbi.nlm.nih.gov/15699447Successful Treatment of Refractory Orthostatic Intolerance (OI) With Droxidopa.
Christina Kokorelis, Joann Bodurtha, Kelsey Guthrie...
https://pubmed.ncbi.nlm.nih.gov/35678018Orthostatic intolerance after bariatric surgery: A systematic review and meta-analysis.
Jawahar Al Nou'mani, Abdullah M Al Alawi, Henrik Falhammar...
https://pubmed.ncbi.nlm.nih.gov/34409762Orthostatic Intolerance after Bariatric Surgery: a Systematic Review.
Mohammad Kermansaravi, Sonja Chiappetta, Panagiotis Lainas...
https://pubmed.ncbi.nlm.nih.gov/33655427