RECRUITING

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

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Conditions

Autonomic DysfunctionOrthostatic Intolerance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study

Quick Facts

Study Start:2024-02-12
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06289413

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the age of 18 - 85 years
  2. * Can provide consent
  3. * Negative urine B-hCG
  4. * Continued follow-up with the bariatric surgery team.
  5. * BS includes one of the following: gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.
  6. * Phase I: Underwent BS within the last 3 years
  7. * Phase II: Will undergo BS within the next 3 months or underwent BS in the last 30 days
  1. * Unable to provide consent
  2. * Pregnant or breastfeeding
  3. * BMI \< 35
  4. * Revision surgery of one of the following BS from above
  5. * Prior history of autonomic dysfunction prior to BS
  6. * Developed AD 72 months post-procedure
  7. * No evidence of AD/OI

Contacts and Locations

Study Contact

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

Principal Investigator

Dhanunjaya Lakkireddy
PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute

Study Locations (Sites)

Menorah Medical Center
Overland Park, Kansas, 66209
United States
Bariatric and Metabolic Specialists
Overland Park, Kansas, 66211
United States
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
United States
Centerpoint Medical Center Clinic
Independence, Missouri, 64057
United States
Centerpoint Medical Center
Independence, Missouri, 64057
United States
Research Medical Center Clinic
Kansas City, Missouri, 64032
United States
Research Medical Center
Kansas City, Missouri, 64032
United States

Collaborators and Investigators

Sponsor: Kansas City Heart Rhythm Research Foundation

  • Dhanunjaya Lakkireddy, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Autonomic Dysfunction
  • Orthostatic Intolerance