Autonomic Dysfunction Clinical Trial
Official title:
Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
NCT number | NCT06289413 |
Other study ID # | KCHRRF_ADiPOSE_0027 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | June 2026 |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | |
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 |
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 |
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 |
United States,
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* Note: There are 18 references in all — Click here to view all references
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 |
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