Status:
COMPLETED
The Suppression of Toll Like Receptors by Insulin
Lead Sponsor:
University at Buffalo
Collaborating Sponsors:
American Diabetes Association
Conditions:
Insulin Resistance
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief 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.
Detailed Description
Obesity and type 2 diabetes are major health problems in the United States and the world. Both conditions are characterized by increased inflammation and oxidative stress and are associated with incre...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Lean Group:
- Age: 20 to 65 years of age inclusive
- Sex: male or female
- Normal fasting plasma glucose (65-100 mg/dl)
- Normal BMI (20-25)
- Obese Group:
- Age: 20 to 65 years of age inclusive
- Sex: male or female
- Normal fasting plasma glucose (65-100 mg/dl)
- BMI\> 30
- DM Group:
- Type 2 Diabetes Mellitus
- Age: 20 to 65 years of age inclusive
- Sex: male or female
- BMI \>30
- Hba1c \< 8%
- 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
- Pregnancy
- Congestive heart failure
- Heart Rate \<50 beats /minute
- Sick Sinus Syndrome
- Second or third degree heart block
- Blood pressure \<80 mm systolic or \> 160/100 mmHg
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous three months
- Hepatic disease (transaminase \> 3 times normal)
- Renal impairment (serum creatinine \> 1.5)
- History of drug or alcohol abuse within past one year
- Participation in any other concurrent clinical trial
- Potassium (K+) values \<3.5 meq/l to \> 5.5 meq/l)
- Any other life-threatening, non-cardiac disease
- Use of an investigational agent or therapeutic regimen within 30 days of study
- Type 2 diabetics on thiazolidinediones and/ or insulin
- Subjects on steroids, NSAIDS or antioxidants
- Patients taking exenatide or sitaglipin or loop diuretics
- Anemia (Hemoglobin level less than 12gm/dl in females and 13gm/dl in males) 19)Allergy to lidocaine
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01151605
Start Date
September 1 2008
End Date
December 1 2013
Last Update
January 5 2024
Active Locations (1)
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1
Millard Fillmore Gates Hospital
Buffalo, New York, United States, 14209