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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01146704
Eligibility Criteria:
Inclusion Criteria:
For inclusion in the study, patients must fulfill all of the following criteria:
* Subjects must be able to attend all 7 scheduled study visits at the West LA GI clinic at the VAGLAHS, not including the screening visit.
* Subjects must sign the VA Greater Los Angeles Healthcare System Institutional Review Board approved written informed consent prior to the initiation of any study-related activities or study specific procedures or randomization.
* Subjects must have given written authorization for the release of protected health information in compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.
After the Informed Consent process, these additional Inclusion Criteria will be applied to potential subjects:
* Age 30 years and older at screening.
* BMI of 27 to 40 kg/m2 inclusive.
* Subjects must be in good health as determined by medical history, physical examination performed by the Investigator (Study doctor) at the Screening stage, and screening clinical laboratory tests including chemistry panel and CBC.
* Must have stable smoking habits (or be non-smokers) for at least 6 months prior to screening and agree not to intend to change such habits during the course of the study.
* Subjects requiring the regular use of any prescription medication may be admitted to the study, providing the dose is stable.
* Subjects must be able to communicate and cooperate with the Principal Investigator and the staff and willing to comply with the study instructions.
Exclusion Criteria:
* Weight instability: Subjects reporting weight change of greater than 3.0 kg in the month prior to screening.
* Any subject who has been on a very low calorie diet (less than 800 kcal/day) for a period of 4 months or more in the 12 months prior to screening, or who has lost greater than 10 kg in the 6 months prior to screening.
* Any subject who has a history of diabetic gastroparesis or gastric emptying disorder as indicated in the potential subject's medical history and VA's Computer Patient Record System (CPRS).
* Use of any other investigational drug(s) within 8 weeks prior to screening.
* Subjects should not have received antibiotics within the prior 4 weeks of screening.
* Abnormal laboratory parameters:
* Serum creatinine greater than 1.6 mg/dL;
* Liver function tests, alanine transaminase (ALT), alanine transaminase (AST), Bilirubin results greater than 2.0 times the upper limit of normal;
* Triglycerides greater than 500 mg/dL;
* Total cholesterol greater than 350 mg/dL;
* Thyroid-stimulating hormone (TSH) outside of normal range disorder, as indicated in the potential subject's medical history, the VA's Computer Patient Record System (CPRS) and laboratory tests performed during the screening process.
* Subjects who drink more than 1 alcoholic beverage per day (that is: 1 beer; or 1 glass of wine; or 1 shot of liquor).
* Pregnant women or women likely to become pregnant during the course of the study may not participate in this study. Female subjects must not be able to conceive by reason of surgery, radiation, one year past the onset of menopause, or an approved method of contraception.
* No vulnerable subjects will be included in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01146704
Study Brief:
Protocol Section:
NCT01146704