Understanding autonomic dysfunction after bariatric surgery
Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Kansas City Heart Rhythm Research Foundation · NCT06289413
This study looks at how common autonomic dysfunction is in people who have had bariatric surgery and what effects it has on their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Kansas City Heart Rhythm Research Foundation (other) |
| Locations | 8 sites (Overland Park, Kansas and 7 other locations) |
| Trial ID | NCT06289413 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence and outcomes of autonomic dysfunction (AD) in patients who have undergone bariatric surgery (BS). It includes both retrospective and prospective phases to gather comprehensive data on patients who have had gastric bypass, sleeve gastrectomy, or biliopancreatic diversion. The study seeks to clarify the underlying pathophysiology of orthostatic intolerance (OI) following BS, addressing gaps in existing literature regarding its incidence and characteristics. By analyzing patient outcomes, the study hopes to provide valuable insights into this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have undergone or are scheduled to undergo specific types of bariatric surgery.
Not a fit: Patients with a prior history of autonomic dysfunction or those who do not exhibit evidence of autonomic dysfunction after surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of autonomic dysfunction in bariatric surgery patients.
How similar studies have performed: While previous studies have explored related topics, this study addresses significant gaps in the evidence base, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Overland Park, Kansas and 7 other locations
- Menorah Medical Center — Overland Park, Kansas, United States (RECRUITING)
- Bariatric and Metabolic Specialists — Overland Park, Kansas, United States (RECRUITING)
- Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States (RECRUITING)
- Overland Park Regional Medical Center — Overland Park, Kansas, United States (RECRUITING)
- Centerpoint Medical Center Clinic — Independence, Missouri, United States (RECRUITING)
- Centerpoint Medical Center — Independence, Missouri, United States (RECRUITING)
- Research Medical Center Clinic — Kansas City, Missouri, United States (RECRUITING)
- Research Medical Center — Kansas City, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Dhanunjaya Lakkireddy — Kansas City Heart Rhythm Institute
- Study coordinator: Donita Atkins
- Email: datkins@kchrf.com
- Phone: 816-651-1969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autonomic Dysfunction, Orthostatic Intolerance