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 @ 1:31 PM
Ignite Modification Date:
2025-12-24 @ 1:31 PM
NCT ID:
NCT05717595
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for a RYGB gastric bypass\*
* Men and premenopausal women \> 18 years of age
* Caucasian descent
* Ability to provide written informed consent
\* All subjects on the waiting list meet the criteria for bariatric surgery, that is:
* BMI \> 40 kg/m2 OR \>35 kg/m2 with obesity related co-morbidity
* Reasonable supervised attempts to lose weight
Exclusion Criteria:
* Unstable metabolic condition defined as;
* Diabetes with poor glycemic control (HbA1c \> 8.5%);
* Use of an antidiabetic or anti-obesity drug;
* Malabsorptive or restrictive bariatric (weight loss) surgery in history
* Evidence for a form of liver disease (except for NAFLD without cirrhosis)
* Known genetic basis for insulin resistance or glucose intolerance
* Use of certain drugs known to produce hepatic steatosis in the previous 6 months (such as oral corticosteroids, high-dose estrogens, methotrexate, tetracycline, amiodarone)
* Malabsorptive disease orders (celiac disease, inflammatory bowel disease)
* Use of certain drugs that may injure the lining of the intestine in the previous months (colchicine, cholestyramine)
* Excessive alcohol intake (≥5 IU per day or ≥ 14 IU per week)
* Recent use of antibiotics (≤ 3 months before surgery)
* Hemostasis disorders or current treatment with anticoagulants Any primary lipid disorder
* Unable to maintain diet intervention, or unable to reliably rapport diet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05717595
Study Brief:
Protocol Section:
NCT05717595