NCT06289413 Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
| NCT ID | NCT06289413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kansas City Heart Rhythm Research Foundation |
| Condition | Autonomic Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-02-12 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Dhanunjaya Lakkireddy
PRINCIPAL INVESTIGATOR
Kansas City Heart Rhythm Institute
Frequently Asked Questions
Who can join the NCT06289413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Autonomic Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06289413 currently recruiting?
Yes, NCT06289413 is actively recruiting participants. Contact the research team at datkins@kchrf.com for enrollment information.
Where is the NCT06289413 trial being conducted?
This trial is being conducted at Overland Park, United States, Overland Park, United States, Overland Park, United States, Overland Park, United States and 4 additional locations.
Who is sponsoring the NCT06289413 clinical trial?
NCT06289413 is sponsored by Kansas City Heart Rhythm Research Foundation. The principal investigator is Dhanunjaya Lakkireddy at Kansas City Heart Rhythm Institute. The trial plans to enroll 400 participants.