Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06059651
Eligibility Criteria:
For an eligible subject, all the following must be answered "yes":
* Biological female sex
* Age \>=35 and \<=60 years (including pre- and postmenopausal)
* Self-reported white or black race
* The study will enroll approximately 50% white and 50% black subjects
* Body mass index \>/=40 kg/m2
* Have a diagnosis of hyperlipidemia (high triglycerides and LDL-cholesterol) or in treatment with any medication for hyperlipidemia at enrollment
* Ability to provide written informed consent
* Allow the collection and storage of biospecimens and data for future use
* Not having yet started the pre-op liquid diet before the bariatric surgery
For an eligible subject, all the following must be answered "no":
* Have type one or type two diabetes
* Use of anti-inflammatory medications, such as glucocorticoids or non-steroidal anti-inflammatory medications, within the past 15 days
* Use of medication approved for obesity management, including, but not limited to, phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), liraglutide (Saxenda), and semaglutide (Wegovy)
* History of cancer of any type
* History of chronic conditions known to cause inflammation, such as tuberculosis, autoimmune disease, and human immunodeficiency virus
* An acute history (within the past 60 days) or confirmed or suspected SARS-CoV-2 (COVID-19) infection
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 52 weeks
* Currently participating in another study with competing outcomes
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT06059651
Study Brief:
Protocol Section:
NCT06059651