Status:
TERMINATED
Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
Lead Sponsor:
Indiana University
Conditions:
Pre-diabetes
Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Aims: 1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? 2. Are there benefits of anti-inflammatory treatment strat...
Detailed Description
We set out to pursue the following Aims: 1. Does inflammation contribute importantly to concurrent defects in vascular and metabolic dysfunction in human pre-diabetic obesity? Pilot studies were perf...
Eligibility Criteria
Inclusion
- healthy
- normotensive (BP\<140/95 mmHg)
- lean and obese
- 18 and 55 years
- women must be premenopausal
Exclusion
- use of pharmacologic agents or recreational drugs, with the exception of occasional use of non-narcotic pain medications
- blood pressure (\>140/90 mmHg)
- elevated cholesterol (LDL \>130 mg/dL)
- diabetes mellitus (by ADA criteria)
- evidence of coronary and/or peripheral vascular disease by history and physical exam
- \>5 kg change in weight in the preceding 3 months
- chronic systemic illness with recognized metabolic effects
- hepatitis C and HIV
- recognized systemic inflammatory or autoimmune processes such as rheumatoid arthritis or systemic lupus erythematosis
- Raynaud's phenomenon or other abnormalities of hand or finger perfusion
- regular participation in endurance or high-performance athletic activity
- history of aspirin or salsalate sensitivity including aspirin-induced asthma
- prior treatment with salsalate, pentoxyfilline, or monoclonal anti-TNFalpha antibodies
- pregnancy
- liver transaminase levels \>3 times the upper limit of normal
- creatinine \>1.5 mg/dL
- history of a cellular immunodeficiency-related opportunistic infections, such as an endemic mycosis (eg. histoplasmosis) or mycobacterial infection (eg tuberculosis)
- reactive tuberculin skin test
- history of malignancy except for basal cell carcinoma of the skin
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00837590
Start Date
March 1 2009
End Date
August 1 2010
Last Update
August 1 2019
Active Locations (1)
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1
Indiana Clinical Research Center
Indianapolis, Indiana, United States, 46202