Document Detail


Profibrinolytic, antithrombotic, and antiinflammatory effects of an insulin-sensitizing strategy in patients in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.
MedLine Citation:
PMID:  21768545     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Effects were compared in patients in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial of 2 mechanistically different strategies for treatment of hyperglycemia, insulin-sensitizing and insulin-providing strategies, on biomarker profiles reflecting the balance between fibrinolysis and thrombosis and the intensity of inflammation implicated in diabetic vasculopathy.
METHODS AND RESULTS: A total of 2368 patients with type 2 diabetes mellitus and clinically stable, angiographically documented coronary artery disease were randomized to treatment with 1 of the 2 strategies and followed for an average of 5 years. Plasminogen activator inhibitor type 1 antigen and activity, tissue plasminogen activator antigen, fibrinogen, D-dimer, C-reactive protein, insulin, and hemoglobin A(1c) were assayed in blood samples acquired at baseline and at 12 regular intervals throughout the follow-up interval. Higher baseline D-dimer, fibrinogen, and C-reactive protein portended a poor prognosis in patients in both groups. In contrast to the insulin-providing strategy, the insulin-sensitizing strategy led to (1) lower plasma insulin; (2) lower plasminogen activator inhibitor type 1 antigen and activity and lower tissue plasminogen activator antigen (known to track with plasminogen activator inhibitor type 1); and (3) lower C-reactive protein and fibrinogen at all intervals after baseline (P<0.001 for each).
CONCLUSIONS: The insulin-sensitizing treatment strategy led to changes in biomarker profiles indicative of decreased insulin resistance, an altered balance between thrombosis and fibrinolysis favoring fibrinolysis, and diminished intensity of the systemic inflammatory state, factors that have been associated with cardiovascular risk.
CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.
Authors:
Burton E Sobel; Regina M Hardison; Saul Genuth; Maria M Brooks; Robert D McBane; David J Schneider; Richard E Pratley; Kurt Huber; Robert Wolk; Ashok Krishnaswami; Robert L Frye;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2011-07-18
Journal Detail:
Title:  Circulation     Volume:  124     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-08-09     Completed Date:  2011-10-07     Revised Date:  2014-11-18    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  695-703     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00006305
Export Citation:
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MeSH Terms
Descriptor/Qualifier:
Adult
Biological Markers
C-Reactive Protein / analysis
Coronary Disease / blood*,  mortality,  therapy
Diabetes Mellitus, Type 2 / blood,  complications,  drug therapy*
Drug Therapy, Combination
Female
Fibrin Fibrinogen Degradation Products / analysis
Fibrinogen / analysis
Fibrinolysis / drug effects
Follow-Up Studies
Hemoglobin A, Glycosylated / analysis
Humans
Hypoglycemic Agents / administration & dosage,  pharmacology,  therapeutic use*
Inflammation
Insulin / administration & dosage,  analysis,  therapeutic use
Insulin Resistance
Kaplan-Meier Estimate
Male
Metformin / administration & dosage,  therapeutic use
Middle Aged
Myocardial Revascularization
Plasminogen Activator Inhibitor 1 / analysis
Prognosis
Sulfonylurea Compounds / administration & dosage,  therapeutic use
Thiazolidinediones / administration & dosage,  therapeutic use
Thrombophilia / blood*,  etiology
Tissue Plasminogen Activator / analysis
Grant Support
ID/Acronym/Agency:
R01 HL71306/HL/NHLBI NIH HHS; R21 HL121495/HL/NHLBI NIH HHS; U01 HL061744/HL/NHLBI NIH HHS; U01 HL061744/HL/NHLBI NIH HHS; U01 HL061746/HL/NHLBI NIH HHS; U01 HL061748/HL/NHLBI NIH HHS; U01 HL063804/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Fibrin Fibrinogen Degradation Products; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Insulin; 0/Plasminogen Activator Inhibitor 1; 0/SERPINE1 protein, human; 0/Sulfonylurea Compounds; 0/Thiazolidinediones; 0/fibrin fragment D; 2295-31-0/2,4-thiazolidinedione; 9001-32-5/Fibrinogen; 9007-41-4/C-Reactive Protein; 9100L32L2N/Metformin; EC 3.4.21.68/Tissue Plasminogen Activator
Comments/Corrections
Comment In:
Circulation. 2011 Aug 9;124(6):663-5   [PMID:  21824932 ]

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