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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT02532335
Eligibility Criteria:
Inclusion Criteria:
Morbid obesity awaiting gastric bypass surgery, ≥35 kg/m2
Male subjects, pre-, and post-menopausal female subjects
Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives
Patients eligible to laparoscopic bariatric surgery
Patients must give their signed and dated written consent to participate in this study based on written information of all pertinent aspects of the trial provided at least 24 hours before undertaking any trial related activity.
Exclusion Criteria:
Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
Previous gastric or small bowel surgery
Inflammatory bowel disease
Uncontrolled diabetes mellitus (fasting blood glucose \>6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease.
Pregnancy. A urine pregnancy test will be performed the day before start of medication. Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives.
Elevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN (upper limit of normal) the day before start of medication.
Other serious disease, including depressive disorders treated by medication
Patients who will not comply with the protocol.
Hypothyroidism, unless the subject is clinically euthyroid, receiving a stable dose thyroid hormone replacement therapy and serum TSH is within the normal range.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02532335
Study Brief:
Protocol Section:
NCT02532335