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:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT01063127
Eligibility Criteria:
Inclusion Criteria:
* Morbidly obese subjects of both sexes with a BMI \>40 kg/m2 who, for their obesity disease, are eligible for bariatric surgery and have accepted to undergo RYGB or LAGB
* Confirmed insulin resistance as assessed by Matsuda index
* Age 25-55 years
* Weight stable for at least 6 months before the study (+/- 5 kg within the previous 6 months)
* Stable medication
* Provision of informed consent, statistical analysis, and publications of obtained results
Exclusion Criteria:
* Patients not eligible for laparoscopic RYGB or LAGB
* Incapacity to give a valid informed consent or unwilling to give the consent
* Pregnancy or lactating
* Patients eligible for RYGB/LAGB, but with:
* Type 2-diabetes mellitus
* Significant illness within the two weeks preceding surgery, as judged by the physician.
* Obvious infection (bacteria, virus etc)
* Major cardiovascular disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT01063127
Study Brief:
Protocol Section:
NCT01063127