Goodarzi MO, Taylor KD, Scheuner MT, Antoine HJ, Guo X, Shah PK, Rotter JI Haplotypes in the lipoprotein lipase gene influence high-density lipoprotein cholesterol response to statin therapy and progression of atherosclerosis in coronary artery bypass grafts. Pharmacogenomics J. 2007 Feb;7(1):66-73. Epub 2006 Jun 6.
Hsueh WA, Orloski L, Wyne K Prediabetes: the importance of early identification and intervention. Postgrad Med. 2010 Jul;122(4):129-43. doi: 10.3810/pgm.2010.07.2180. Review.
Look AHEAD Research Group, Wing RR Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial. Arch Intern Med. 2010 Sep 27;170(17):1566-75. doi: 10.1001/archinternmed.2010.334.
Mari A, Degn K, Brock B, Rungby J, Ferrannini E, Schmitz O Effects of the long-acting human glucagon-like peptide-1 analog liraglutide on beta-cell function in normal living conditions. Diabetes Care. 2007 Aug;30(8):2032-3. Epub 2007 Apr 27.
Matveyenko AV, Butler PC Relationship between beta-cell mass and diabetes onset. Diabetes Obes Metab. 2008 Nov;10 Suppl 4:23-31. doi: 10.1111/j.1463-1326.2008.00939.x.
Villareal DT, Banks MR, Patterson BW, Polonsky KS, Klein S Weight loss therapy improves pancreatic endocrine function in obese older adults. Obesity (Silver Spring). 2008 Jun;16(6):1349-54. doi: 10.1038/oby.2008.226. Epub 2008 Apr 3.
Improving Beta Cell Function in Mexican American Women With Prediabetes
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.
