Study Results
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Basic Information
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WITHDRAWN
OBSERVATIONAL
2017-10-01
2023-01-10
Brief Summary
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Detailed Description
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Insulin is an important anabolic hormone that prevents protein breakdown and to a lesser extent stimulates protein synthesis. There is some evidence that the ability of insulin to stimulate anabolic processes may be reduced in diabetes.
Insulin has cardiovascular properties, resulting in simultaneous adrenergic and vasodilatory responses that have opposing influences on blood pressure. Epidemiological studies have demonstrated that the use of insulin is a risk factor for syncope.
The investigators will study 30 older adults age 65 and older with type 2 diabetes who have never taken insulin to manage their diabetes but now need insulin to manage their diabetes. Data will be compared pre insulin start and 3 and 6 months after starting insulin.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Type 2 Diabetes, Insulin Naive
Study participants will be tested prior to and 3 and 6 months after starting insulin to manage their diabetes
Insulin Lispro
Insulin
Interventions
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Insulin Lispro
Insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes for at least 5 years
* Insulin naive
* now needs insulin to manage diabetes
Exclusion Criteria
* abnormal liver function tests
* elevated serum creatinine
* smoked within last 5 years
* musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals
* aortic stenosis
65 Years
ALL
No
Sponsors
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Kenneth Madden
OTHER
Responsible Party
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Kenneth Madden
Associate Professor, UBC Department of Medicine
Principal Investigators
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Madden M Kenneth, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia/Gerontology Research Lab
Locations
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University of British Columbia - Gerontology Research Lab
Vancouver, British Columbia, Canada
Countries
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References
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Morley JE, Malmstrom TK, Rodriguez-Manas L, Sinclair AJ. Frailty, sarcopenia and diabetes. J Am Med Dir Assoc. 2014 Dec;15(12):853-9. doi: 10.1016/j.jamda.2014.10.001. Epub 2014 Nov 20. No abstract available.
Rizzo MR, Barbieri M, Fava I, Desiderio M, Coppola C, Marfella R, Paolisso G. Sarcopenia in Elderly Diabetic Patients: Role of Dipeptidyl Peptidase 4 Inhibitors. J Am Med Dir Assoc. 2016 Oct 1;17(10):896-901. doi: 10.1016/j.jamda.2016.04.016. Epub 2016 Jun 2.
Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Meneilly GS, Knip A, Tessier D. Diabetes in the elderly. Can J Diabetes. 2013 Apr;37 Suppl 1:S184-90. doi: 10.1016/j.jcjd.2013.01.045. Epub 2013 Mar 26. No abstract available.
Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.
Bassil MS, Gougeon R. Muscle protein anabolism in type 2 diabetes. Curr Opin Clin Nutr Metab Care. 2013 Jan;16(1):83-8. doi: 10.1097/MCO.0b013e32835a88ee.
Salle A, Guilloteau G, Ryan M, Bouhanick B, Ritz P. Effect of insulin treatment on the body composition of Type 2 diabetic patients. Diabet Med. 2004 Dec;21(12):1298-303. doi: 10.1111/j.1464-5491.2004.01335.x.
Gin H, Rigalleau V, Perlemoine C. Insulin therapy and body weight, body composition and muscular strength in patients with type 2 diabetes mellitus. J Nutr Metab. 2010;2010:340570. doi: 10.1155/2010/340570. Epub 2009 Oct 21.
de Kanter M, Lilja B, Elmstahl S, Eriksson KF, Sundkvist G. A prospective study of orthostatic blood pressure in diabetic patients. Clin Auton Res. 1998 Aug;8(4):189-93. doi: 10.1007/BF02267780.
Gupta V, Lipsitz LA. Orthostatic hypotension in the elderly: diagnosis and treatment. Am J Med. 2007 Oct;120(10):841-7. doi: 10.1016/j.amjmed.2007.02.023.
Vinik AI, Erbas T. Cardiovascular autonomic neuropathy: diagnosis and management. Curr Diab Rep. 2006 Dec;6(6):424-30. doi: 10.1007/s11892-006-0074-z.
Tack CJ, Lenders JW, Willemsen JJ, van Druten JA, Thien T, Lutterman JA, Smits P. Insulin stimulates epinephrine release under euglycemic conditions in humans. Metabolism. 1998 Mar;47(3):243-9. doi: 10.1016/s0026-0495(98)90251-7.
Tack CJ, Smits P, Willemsen JJ, Lenders JW, Thien T, Lutterman JA. Effects of insulin on vascular tone and sympathetic nervous system in NIDDM. Diabetes. 1996 Jan;45(1):15-22. doi: 10.2337/diab.45.1.15.
Meneilly GS, Elliott T, Battistini B, Floras JS. N(G)-monomethyl-L-arginine alters insulin-mediated calf blood flow but not glucose disposal in the elderly. Metabolism. 2001 Mar;50(3):306-10. doi: 10.1053/meta.2001.19493.
Lipsitz LA, Pluchino FC, Wei JY, Rowe JW. Syncope in institutionalized elderly: the impact of multiple pathological conditions and situational stress. J Chronic Dis. 1986;39(8):619-30. doi: 10.1016/0021-9681(86)90187-6.
Ruiz GA, Calvar C, Hermes R, Rivadeneira D, Bengolea V, Chirife R, Tentori MC, Gelpi RJ. Insulin sensitivity in young women with vasovagal syncope. Am Heart J. 2003 May;145(5):834-40. doi: 10.1016/S0002-8703(02)94707-1.
Stratton JR, Cerqueira MD, Schwartz RS, Levy WC, Veith RC, Kahn SE, Abrass IB. Differences in cardiovascular responses to isoproterenol in relation to age and exercise training in healthy men. Circulation. 1992 Aug;86(2):504-12. doi: 10.1161/01.cir.86.2.504.
Madden KM, Tedder G, Lockhart C, Meneilly GS. Euglycemic hyperinsulinemia alters the response to orthostatic stress in older adults with type 2 diabetes. Diabetes Care. 2008 Nov;31(11):2203-8. doi: 10.2337/dc08-1058. Epub 2008 Aug 20.
Sergi G, De Rui M, Stubbs B, Veronese N, Manzato E. Measurement of lean body mass using bioelectrical impedance analysis: a consideration of the pros and cons. Aging Clin Exp Res. 2017 Aug;29(4):591-597. doi: 10.1007/s40520-016-0622-6. Epub 2016 Aug 27.
Ziegler D, Laux G, Dannehl K, Spuler M, Muhlen H, Mayer P, Gries FA. Assessment of cardiovascular autonomic function: age-related normal ranges and reproducibility of spectral analysis, vector analysis, and standard tests of heart rate variation and blood pressure responses. Diabet Med. 1992 Mar;9(2):166-75. doi: 10.1111/j.1464-5491.1992.tb01754.x.
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
Del Rosso A, Ungar A, Bartoli P, Cellai T, Mussi C, Marchionni N, Masotti G; Gruppo Italiano di Studio Della Sincope Dell'anziano. Usefulness and safety of shortened head-up tilt testing potentiated with sublingual glyceryl trinitrate in older patients with recurrent unexplained syncope. J Am Geriatr Soc. 2002 Aug;50(8):1324-8. doi: 10.1046/j.1532-5415.2002.50351.x.
Lipsitz LA, Mukai S, Hamner J, Gagnon M, Babikian V. Dynamic regulation of middle cerebral artery blood flow velocity in aging and hypertension. Stroke. 2000 Aug;31(8):1897-903. doi: 10.1161/01.str.31.8.1897.
Other Identifiers
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H17-01663
Identifier Type: -
Identifier Source: org_study_id
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