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

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pre-diabetes; Obesity

Intervention: salsalate (Drug); metformin (Drug); lisinopril (Drug)

Phase: N/A

Status: Completed

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
Kieren J Mather, MD, Principal Investigator, Affiliation: Indiana University

Summary

We intend to pursue the following 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? 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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary endpoints of interest are basal flow and diameter, flow-mediated vasodilation, insulin-stimulated glucose disposal and insulin-mediated vasodilation measured by brachial artery ultrasound

Secondary outcome: Other endpoints of interest include circulating levels of endothelin and nitric oxide, levels of inflammatory markers, circulating endothelial progenitor cell numbers, and steady-state glucose disposal rate for the insulin infusion study.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Indiana Clinical Research Center, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: March 2009
Last updated: May 21, 2012

Page last updated: August 23, 2015

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