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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT01151605
Eligibility Criteria:
INCLUSION CRITERIA
Lean Group:
1. Age: 20 to 65 years of age inclusive
2. Sex: male or female
3. Normal fasting plasma glucose (65-100 mg/dl)
4. Normal BMI (20-25)
Obese Group:
1. Age: 20 to 65 years of age inclusive
2. Sex: male or female
3. Normal fasting plasma glucose (65-100 mg/dl)
4. BMI\> 30
DM Group:
1. Type 2 Diabetes Mellitus
2. Age: 20 to 65 years of age inclusive
3. Sex: male or female
4. BMI \>30
5. Hba1c \< 8%
6. If on statins, angiotensin converting enzyme inhibitor, angiotensin receptor blocker or low dose aspirin, should be on a stable dose for one month.
EXCLUSION CRITERIA
1. Pregnancy
2. Congestive heart failure
3. Heart Rate \<50 beats /minute
4. Sick Sinus Syndrome
5. Second or third degree heart block
6. Blood pressure \<80 mm systolic or \> 160/100 mmHg
7. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous three months
8. Hepatic disease (transaminase \> 3 times normal)
9. Renal impairment (serum creatinine \> 1.5)
10. History of drug or alcohol abuse within past one year
11. Participation in any other concurrent clinical trial
12. Potassium (K+) values \<3.5 meq/l to \> 5.5 meq/l)
13. Any other life-threatening, non-cardiac disease
14. Use of an investigational agent or therapeutic regimen within 30 days of study
15. Type 2 diabetics on thiazolidinediones and/ or insulin
16. Subjects on steroids, NSAIDS or antioxidants
17. Patients taking exenatide or sitaglipin or loop diuretics
18. Anemia (Hemoglobin level less than 12gm/dl in females and 13gm/dl in males) 19)Allergy to lidocaine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01151605
Study Brief:
Protocol Section:
NCT01151605