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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00837590
First received: February 4, 2009
Last updated: May 21, 2012
Last verified: April 2012
History of Changes

February 4, 2009
May 21, 2012
March 2009
June 2010   (final data collection date for primary outcome measure)
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 [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837590 on ClinicalTrials.gov Archive Site
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. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls
Vascular Function, Endothelin, and Inflammation in Pre-diabetic Obesity Versus Lean Healthy Controls

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pre-diabetes
  • Obesity
  • Drug: salsalate
    Subjects will receive 2 months of treatment with 4 gram/day of oral salsalate divided into 3 doses.
  • Drug: metformin
    metformin po 1000mg bid
  • Drug: lisinopril
    lisinopril po 20mg qd
  • Experimental: 1
    Nondiabetic lean and obese subjects will be studied in this arm. Subjects will be studied at baseline and after 2 months of treatment with salsalate.
    Intervention: Drug: salsalate
  • Experimental: Metformin
    Obese subjects will be pre-treated with metformin 1000mg bid for 4 weeks prior to baseline measurements and will continue metformin in addition to salsalate for an additional 2 months.
    Interventions:
    • Drug: salsalate
    • Drug: metformin
  • Experimental: Lisinopril
    Obese subjects will be pre-treated with lisinopril 20mg qd for 4 weeks prior to baseline measurements and continue lisinopril in addition to salsalate for an additional 2 months.
    Interventions:
    • Drug: salsalate
    • Drug: lisinopril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837590
IU-IRB-0901-03
Yes
Indiana University
Indiana University
Not Provided
Principal Investigator: Kieren J Mather, MD Indiana University
Indiana University
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP