Type 2 Diabetes — Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Citation(s)
Andreassen CS, Jakobsen J, Andersen H Muscle weakness: a progressive late complication in diabetic distal symmetric polyneuropathy. Diabetes. 2006 Mar;55(3):806-12. doi: 10.2337/diabetes.55.03.06.db05-1237.
Andreassen CS, Jakobsen J, Ringgaard S, Ejskjaer N, Andersen H Accelerated atrophy of lower leg and foot muscles--a follow-up study of long-term diabetic polyneuropathy using magnetic resonance imaging (MRI). Diabetologia. 2009 Jun;52(6):1182-91. doi: 10.1007/s00125-009-1320-0. Epub 2009 Mar 12. Erratum In: Diabetologia. 2009 Jul;52(7):1454.
IJzerman TH, Schaper NC, Melai T, Meijer K, Willems PJ, Savelberg HH Lower extremity muscle strength is reduced in people with type 2 diabetes, with and without polyneuropathy, and is associated with impaired mobility and reduced quality of life. Diabetes Res Clin Pract. 2012 Mar;95(3):345-51. doi: 10.1016/j.diabres.2011.10.026. Epub 2011 Nov 21.
Merlotti D, Gennari L, Dotta F, Lauro D, Nuti R Mechanisms of impaired bone strength in type 1 and 2 diabetes. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):683-90. doi: 10.1016/j.numecd.2010.07.008.
Stenholm S, Harkanen T, Sainio P, Heliovaara M, Koskinen S Long-term changes in handgrip strength in men and women--accounting the effect of right censoring due to death. J Gerontol A Biol Sci Med Sci. 2012 Oct;67(10):1068-74. doi: 10.1093/gerona/gls064. Epub 2012 Mar 15.
Vestergaard P Discrepancies in bone mineral density and fracture risk in patients with type 1 and type 2 diabetes--a meta-analysis. Osteoporos Int. 2007 Apr;18(4):427-44. doi: 10.1007/s00198-006-0253-4. Epub 2006 Oct 27.
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
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.