Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 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?

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indiana University
• Treatments: Lisinopril; Metformin; Salicylsalicylic acid; Sodium Salicylate

Criteria

Inclusion Criteria:

• healthy

• normotensive (BP<140/95 mmHg)

• lean and obese

• 18 and 55 years

• women must be premenopausal

Exclusion Criteria:

• 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