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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00837590
• Other study ID #: IU-IRB-0901-03
• Status: Terminated
• Phase: Phase 1
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: May 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 performed exploring the acute actions of salsalate on vascular function, the chronic actions of salasate in obese individuals, and actions of chronic salsalate to prevent vascular dysfunction induced by fatty acids in lean individuals.

2. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with metformin? No studies were performed

3. Are there benefits of anti-inflammatory treatment strategies in pre-diabetic obesity in the context of existing treatment with lisinopril? No studies were performed

The intent of the current project is to efficiently and at low cost generate preliminary data along each of these lines of questioning, studying the minimum number of subjects required to assess the viability of the question using the current measurement approaches.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Inflammation
• Obesity
• Pre-diabetes
• Prediabetic State

Intervention

Drug:
• Chronic salsalate
Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
• Acute Salsalate
Subjects will receive a single oral dose of 2 gram of oral salsalate

Locations

Country	Name	City	State
United States	Indiana Clinical Research Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular Function	The primary endpoints of interest is flow-mediated vasodilation	Measured at baseline and after a single oral dose of salsalate (Acute) or 2 months' treatment with salsalate (Chronic)