Vascular Function, Endothelin, and Inflammation in Pre-Diabetic Obesity Versus Lean Healthy Controls
Information source: Indiana University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pre-Diabetes; Obesity
Intervention: salsalate (Drug); metformin (Drug); lisinopril (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s):
Kieren J Mather, MD, Principal Investigator, Affiliation: Indiana University
Overall contact:
Robin L Chisholm, RN, Phone: 317-274-7679, Email: rlchisho@iupui.edu
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: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
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
Robin L Chisholm, RN, Phone: 317-274-7679, Email: rlchisho@iupui.edu
Indiana Clinical Research Center, Indianapolis, Indiana 46202, United States
Additional Information
Starting date: March 2009
Ending date: January 2011
Last updated: February 4, 2009
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