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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT02363335
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Age 21-55 (Age restriction is used to remove age as a confounding factor because (beta) cells function and insulin resistance tend to deteriorate with age and may affect GLP-1 and GIP levels.
2. Screening laboratory evaluations with no clinically significant abnormal results (minor deviations from normal lab results will be at the discretion of the principal investigator):
1. fasting comprehensive metabolic panel
2. complete blood count with differential and platelet
3. thyroid function test (TSH)
4. urine drug screen
5. Point of care urine pregnancy test (for women who are not surgically sterile)
3. BMI \< 30 (participants with BMI greater than or equal to 30 are excluded because obesity has been associated with attenuation in GLP-1 secretion.
4. Have had a history of stable weight (maintained weight within +/- 5%) over the past year
5. Have NOT participated in another clinical trial involving any pharmacologic agents within the past 30 days
6. Able to complete an inform consent
7. Agree to not participate in other clinical trials within the study period (at the discretion of the study investigator)
EXCLUSION CRITERIA:
1. FPG greater than or equal to 100 mg/dl or 2-hr OGTT greater than or equal to 140 mg/dL (evidence of glucose intolerance or diabetes)
2. History of anemia, or Hemoglobin \< 12.5 mg/dL for men and \< 11.5 mg/dL for women during screening visit
3. Weight \< 110 pounds (due to blood volume requirement)
4. Evidence of illicit drug use
5. History of substance abuse including marijuana within the past 6 months
6. History of smoking any tobacco products within six months prior to screening
7. Alcohol intake \> 30 grams (drink more than 2 beers per day OR equivalent amount of alcohol)
8. History of Human Immunodeficiency Virus (HIV) infection
9. History of active or chronic Hepatitis B and/or C infection
10. History of psychiatric illnesses including major depressive disorder, schizophrenia, bipolar disorder
11. Any lifetime history of suicide attempt
12. History of any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the last year
13. Any suicidal ideation of type 4 or 5 on the C-SSRS during any follow-up visits.
14. Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 10 during screening visit or any follow-up study visits
15. Generalized Anxiety Disorder-7 (GAD-7) score greater than or equal to 10 during screening visit or any follow-up visits
16. History of pancreatitis
17. History of liver or renal diseases
18. History of gastrointestinal or endocrine disorders
19. History of malignancy (unless P.I. determines that there is no impact of the prior malignancy on study outcomes, i.e. basal cell skin cancer)
20. History of coronary disease or clinically significant abnormalities on electrocardiogram
21. History of seizures or other neurologic diseases
22. History of glucocorticoid use (over one month) or other immunosuppressive agents (any), i.e. Imuran, Neoral, Sandimmune, SangCya, basiliximab (Simulect), daclizumab (Zenapax), muromonab (Orthocolone OKT(3)) prednisone (Deltasone, Orasone) within the past six months
23. Use of proton pump inhibitors (PPI s), i.e. Prilosec, Prevacid, Achiphex, Protonix, Nexium, Zegarid
24. Women who are pregnant or nursing/breast-feeding a child
25. Any medical history that, in the opinion of the investigator(s), may make participation of the subject in the study unsafe
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
55 Years
Study:
NCT02363335
Study Brief:
Protocol Section:
NCT02363335