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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03414333
Eligibility Criteria:
Inclusion Criteria:(Morbid Obese Subjects Group)
1. Males and females undergoing bariatric surgery as per clinical management
2. Age = 18-60 years
3. BMI\>35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
4. Normal Glucose Tolerance (HbA1c \> 4.5 % and \< 5.7%) or Type 2 diabetes (HbA1c \>5.7 % and \<10.0%)
5. Stable eGFR (\>60 ml/min/1.73 m2 )
6. Drug naive for type 2 diabetes treatment or on stable dose more than 3 months with anti-diabetic agents other than DPP4-inhibitors, GLP1 receptor agonists, and insulin.
7. Subjects are capable of giving informed consent
Inclusion Criteria (Healthy Subjects Group)
1. Males and females
2. Age = 18-60 years
3. BMI 22-35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
4. Stable eGFR (\>60 ml/min/1.73 m 2 )
5. Normal Glucose Tolerance (HbA1c\>4.5 % and\< 5.7%)
6. Subjects are capable of giving informed consent.
Exclusion Criteria:(both groups)
1. Steroids treatment
2. Psychiatric Disorders
3. Mental Retardation
4. Severe cognitive Impairment
5. Neurodegenerative diseases
6. Epilepsy
7. Depression Treatment
8. Traumatic Brain Injury over the preceding six months
9. Liver function enzymes higher more than two times the upper limit
10. Heart Failure (NYHA III-IV)
11. Type 1 Diabetes
12. Diabetic Ketoacidosis
13. GFR\<60 ml/min/1.73 m 2
14. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \> 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
15. Women who are pregnant or breastfeeding
16. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03414333
Study Brief:
Protocol Section:
NCT03414333