Overview

The Suppression of Toll Like Receptors by Insulin

Status:
Unknown status

Trial end date:
2013-12-01

Target enrollment:
0

Participant gender:
All

Summary

This study will help us understand the possible beneficial effects of insulin in inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart disease.

Phase:

Phase 2

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Kaleida Health

Collaborator:

American Diabetes Association

Treatments:

Insulin
Insulin, Globin Zinc

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