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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT02683902
Eligibility Criteria:
Inclusion Criteria:
1. Women of childbearing potential who are using medically approved birth control methods (eg hormonal contraceptives, intra uterine device (IUDs), barrier contraception) and who agree to use the same methods of contraception throughout the course of the study.
2. BMI 25 ≥ 35 Kg/m2 at screening
3. Stable weight for at least 12 weeks prior to screening
4. Able and willing to provide written informed consent and to comply with the requirements of the study protocol
Exclusion Criteria:
1. Pregnant or intend to become pregnant during the study period or who are currently breastfeeding.
2. Women in perimenopause / menopause, or postmenopausal status, or who have had early menopause (under 40 years) or have had a hysterectomy or oophorectomy.
3. Diagnosis or history of diabetes Mellitus type 1, diabetes resulting from pancreatic injury or secondary forms of diabetes, such as, for example, Cushing's syndrome and acromegaly.
3.1. Metabolic and acute complications of diabetes such as ketoacidosis and hyperosmolar coma within the past six months.
4. Gastrointestinal disease clinically symptomatic including, among others, inflammatory bowel disease and/or malabsorption diseases.
5. Have received nutritional counseling in the last six months by a nutritionist.
6. History of severe depression or other serious psychiatric comorbidities.
7. History of gastric bypass, antrectomy or small bowel resection.
8. History of chronic pancreatitis or idiopathic acute pancreatitis
9. Myocardial infarction (MI), coronary arteries bypass surgery, post-transplant cardiomyopathy or stroke in the last 6 months
10. Any abnormality in clinical laboratory tests which might prevent safe participation in the study
11. Diagnosed and / or treated tumor (except basal cell skin cancer, carcinoma in situ of the cervix or prostate cancer in situ) in the last five years.
12. History of known hemoglobinopathy and chronic anemia.
13. Donation of one unit (500 ml) of blood or more, significant blood loss equivalent to at least one unit of blood within the last 2 weeks or blood transfusion in the past 8 weeks.
14. Treatment with any oral antidiabetic drugs and / or herbal preparations or medications that do not require a prescription and can affect glycemic control within 12 weeks prior to screening.
15. Chronic treatment with oral or parenteral corticosteroids (\> 7 consecutive days of treatment) within 4 weeks prior to screening.
16. Treatment with weight loss agents (e.g., orlistat, sibutramine, topiramate, bupropion) in the last 12 weeks prior to screening.
17. Treatment with mineral oil or fiber supplementation (e.g., Benefiber, Metamucil, among others).
18. Treatment with lipid-lowering drugs which have not been kept on a stable dose for the past 8 weeks before screening.
19. Treatment with thyroid replacement hormones which has not been kept on a stable dose for the past 12 weeks prior to screening.
20. Use of drugs under investigation within 30 days or 5 half-lives (whichever is longer) before screening unless the guidelines of local health authorities require a longer period.
21. Any of the following laboratory abnormalities identified in the screening by history and / or tests brought by the patient or that are part of this protocol, as described in section 4.3.4.6 of this project:
21.1. Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) \> 3 times the upper limit of normal 21.2. Glomerular filtration rate estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation ≤ 30 ml per min per 1,73 m2 21.3. Thyroid stimulating hormone (TSH) outside the normal range 21.4. Fasting triglycerides ≥ 400 mg / dL. 21.5. History of active substance abuse (including alcohol) within the past year
22. Any condition or concomitant medical disorder, not provided for in other items which in the opinion of the investigator, probably:
22.1. Interfere with the patient's ability to complete the entire study period or participate in all activities of the study 22.2. Require during the study, administration of a treatment that may affect the interpretation of efficacy and safety data
23. Patients potentially unreliable and those considered by the investigator as unsuitable for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT02683902
Study Brief:
Protocol Section:
NCT02683902