Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
Stopped early · Phase 1
Conditions studied: Pre-diabetes, Obesity
In brief
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 strategies in pre-diabetic obesity in the context of existing treatment with metformin? 3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril?
Key facts
- Study ID
- NCT00837590
- Run by
- Indiana University
- People needed
- 16
- Starts
- 2009-03-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2019-08-01
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- healthy
- normotensive (BP<140/95 mmHg)
- lean and obese
- 18 and 55 years
- women must be premenopausal
You may not qualify if…
- 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
Where it is running
- Indiana Clinical Research Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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