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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT00816218
Eligibility Criteria:
Inclusion Criteria:
1. male or female 18-65 years of age;
2. type 2 diabetes based on the American Diabetes Association criteria;
3. HbA1c = 6.5-9.0% while on diet alone or diet plus sulfonylurea (or meglitinides) therapy;
4. no history of thiazolidinediones, insulin, ACE inhibitor or AII-receptor blockade therapy;
5. taking no medications known to affect glycemic control or endothelial function, unless the medication has been stable for at least 3 months;
6. blood pressure equal or below 140/90 mmHg;
7. not pregnant and willing to take appropriate contraceptive measures if capable of becoming pregnant;
8. serum creatinine below 1.7 mg/dl in female and 1.8 mg/dl in males;
9. ALT (SGTP) or AST (SGOT) less than 2 times the upper limit of normal for the laboratory and absence of clinical signs or symptoms of liver disease;
10. hematocrit \> 34% in females and \>35% in males;
11. normal thyroid function;
12. no evidence of coronary heart disease (by history or EKG) or moderate to severe congestive heart failure (NY Heart Association Cardiac Class III or IV);
13. no history or the presence of any clinically significant or unstable medical condition that makes the subject unlikely to complete the study in the opinion of the PI; and
14. absence of any condition or situations which would preclude adherence and completion of the protocol;
15. the ability to give voluntary informed consent.
Exclusion Criteria:
1. Subjects were excluded from study if they had ever received insulin, metformin, TZDs, exenatide or DPP IV inhibitor.
2. All subjects were free of cardiovascular, renal or major organ disease, as determined by medical history, physical examination, screening blood chemistries, complete blood cell count, and electrocardiogram.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00816218
Study Brief:
Protocol Section:
NCT00816218