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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02043457
Eligibility Criteria:
Inclusion Criteria:
* Obese males and females: age \>20 years; Obese population defined as BMI \> or = 27 kg/m2
* Lean population BMI \< 27 but \> 17 kg/m2
* Able and willing to provide written informed consent for the trial
Exclusion Criteria:
* Evidence of inherited disorders of lipid metabolism.
* History of Cancer within the last 5 years
* Human immunodeficiency virus (HIV) antibody positive.
* Patients with solid organ transplants.
* Participation in any other clinical trial within 90 days of entry into this trial.
* Pregnant or lactating females.
* Uncontrolled thyroid disease
* Unstable angina or NY heart association class II failure or above
* Gastrointestinal disease specifically GI motility disorders
* Unstable neuropsychiatric disease including major depression/anxiety, eating disorder such as binge eating, bulimia or anorexia
* End stage renal or hepatic disease
* Autoimmune disorders (e.g. SLE)
* Body weight fluctuation of more than 5 kg in the previous 3 months
* Prior bariatric surgery
* A history or current alcohol/substance abuse and change in smoking habits or cessation in the past 6 months.
* Women of childbearing age must use a reliable form of contraception.
* Any medical condition, which in the opinion of the investigator would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol.
* Unwilling or unable to consent for the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
75 Years
Study:
NCT02043457
Study Brief:
Protocol Section:
NCT02043457