Bell RA, Mayer-Davis EJ, Martin MA, D'Agostino RB Jr, Haffner SM Associations between alcohol consumption and insulin sensitivity and cardiovascular disease risk factors: the Insulin Resistance and Atherosclerosis Study. Diabetes Care. 2000 Nov;23(11):1630-6.
Cooper DE, Goff DC Jr, Bell RA, Zaccaro D, Mayer-Davis EJ, Karter AJ Is insulin sensitivity a causal intermediate in the relationship between alcohol consumption and carotid atherosclerosis?: the insulin resistance and atherosclerosis study. Diabetes Care. 2002 Aug;25(8):1425-31.
Festa A, D'Agostino R Jr, Mykkänen L, Tracy R, Howard BV, Haffner SM Low-density lipoprotein particle size is inversely related to plasminogen activator inhibitor-1 levels. The Insulin Resistance Atherosclerosis Study. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):605-10.
Festa A, D'Agostino R Jr, Mykkänen L, Tracy RP, Zaccaro DJ, Hales CN, Haffner SM Relative contribution of insulin and its precursors to fibrinogen and PAI-1 in a large population with different states of glucose tolerance. The Insulin Resistance Atherosclerosis Study (IRAS). Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):562-8.
Festa A, D'Agostino R Jr, Rich SS, Jenny NS, Tracy RP, Haffner SM Promoter (4G/5G) plasminogen activator inhibitor-1 genotype and plasminogen activator inhibitor-1 levels in blacks, Hispanics, and non-Hispanic whites: the Insulin Resistance Atherosclerosis Study. Circulation. 2003 May 20;107(19):2422-7. Epub 2003 Apr 28.
Festa A, D'Agostino R Jr, Tracy RP, Haffner SM C-reactive protein is more strongly related to post-glucose load glucose than to fasting glucose in non-diabetic subjects; the Insulin Resistance Atherosclerosis Study. Diabet Med. 2002 Nov;19(11):939-43.
Laws A, Hoen HM, Selby JV, Saad MF, Haffner SM, Howard BV Differences in insulin suppression of free fatty acid levels by gender and glucose tolerance status. Relation to plasma triglyceride and apolipoprotein B concentrations. Insulin Resistance Atherosclerosis Study (IRAS) Investigators. Arterioscler Thromb Vasc Biol. 1997 Jan;17(1):64-71.
Liese AD, Schulz M, Moore CG, Mayer-Davis EJ Dietary patterns, insulin sensitivity and adiposity in the multi-ethnic Insulin Resistance Atherosclerosis Study population. Br J Nutr. 2004 Dec;92(6):973-84.
Mayer-Davis EJ, Kirkner GJ, Karter AJ, Zaccaro DJ Metabolic predictors of 5-year change in weight and waist circumference in a triethnic population: the insulin resistance atherosclerosis study. Am J Epidemiol. 2003 Apr 1;157(7):592-601.
Mayer-Davis EJ, Monaco JH, Marshall JA, Rushing J, Juhaeri Vitamin C intake and cardiovascular disease risk factors in persons with non-insulin-dependent diabetes mellitus. From the Insulin Resistance Atherosclerosis Study and the San Luis Valley Diabetes Study. Prev Med. 1997 May-Jun;26(3):277-83.
Mykkänen L, Zaccaro DJ, Hales CN, Festa A, Haffner SM The relation of proinsulin and insulin to insulin sensitivity and acute insulin response in subjects with newly diagnosed type II diabetes: the Insulin Resistance Atherosclerosis Study. Diabetologia. 1999 Sep;42(9):1060-6.
Sattar N, Williams K, Sniderman AD, D'Agostino R Jr, Haffner SM Comparison of the associations of apolipoprotein B and non-high-density lipoprotein cholesterol with other cardiovascular risk factors in patients with the metabolic syndrome in the Insulin Resistance Atherosclerosis Study. Circulation. 2004 Oct 26;110(17):2687-93. Epub 2004 Oct 18.
Williams K, Sniderman AD, Sattar N, D'Agostino R Jr, Wagenknecht LE, Haffner SM Comparison of the associations of apolipoprotein B and low-density lipoprotein cholesterol with other cardiovascular risk factors in the Insulin Resistance Atherosclerosis Study (IRAS). Circulation. 2003 Nov 11;108(19):2312-6. Epub 2003 Oct 27.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.