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Research

Current Studies Continued...


LEADER

Protocol #EX2211-3748 – “LEADER Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results A long-term, multi-centre, international, randomised double-blind, placebo-controlled trial to determine liraglutide effects on cardiovascular events”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:

The purpose of this research study is determine the effect of liraglutide on heart or blood vessels in subjects with type 2 diabetes.


Study website: www.leadertrial.com


Study Status: Study closed to enrollment



Variation in A1c


“Impact of Biological Variation in A1c on Mortality, Cardiovascular Events, and Hypoglycemia in the ACCORD Study”


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:
The purpose of this research study is to evaluate data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study to determine if biological variation in hemoglobin A1c is associated with clinical outcomes of intensive glycemic control in type 2 diabetes.



DRMS Study

DRMS: Evaluation of a Diabetes Remote Monitoring and Management System


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:
The purpose of this research study is to evaluate how much this new system, together with normal (standard) diabetes care, can help patients better manage their diabetes, including by providing them with improved blood sugar control.


Study Status: Study closed to enrollment



Diabetic Kidney Disease Study

Novel Serum and Urinary Biomarkers of Diabetic Kidney Disease


PI: Vivian A. Fonseca, MD


PROTOCOL SUMMARY:
The overall design of this research is to utilize banked samples from the Action to Control Cardiovascular Disease (ACCORD) trial - a randomized, 2 x 2 factorial design trial of intensive glycemic control (target HbA1C < 6.0%) vs. standard therapy (target HbA1C 7.0 to 7.9%) in 10,251 type 2 diabetics. The intervention lasted for 3.7 years, and total follow-up of patients averaged over 5 years. Predefined secondary microvascular outcomes were measures of kidney function, diabetic eye complications, and peripheral neuropathy. Intensive glycemic control reduced the incidence of microalbuminuria and macroalbuminuria by 21% and 32%, respectively. In addition, the progression of retinopathy, another microvascular outcome, was reduced from 10.4% to 7.3% with intensive glycemic control. However, neither the rate of development of incident CKD (doubling of creatinine and 20 ml/min decrease in eGFR) (5.8% vs. 5.1% in the intensive and standard arms, respectively) nor end-stage renal disease (2.1% vs. 2.2%) differed between the two glycemia-treatment arms. The reasons for these outcomes need to be explored.



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