NCT00837590

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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?

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 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.

Conditions

• Pre-diabetes
• Obesity

Interventions

Type	Name	Description
DRUG	Chronic salsalate	Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
DRUG	Acute Salsalate	Subjects will receive a single oral dose of 2 gram of oral salsalate

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2009-02-05
• Last updated: 2019-08-01
• Results posted: 2019-08-01

Locations

1 site across 1 country: United States