Effects of Insulin on Hypotension and Sarcopenia

NCT03248271 | Withdrawn

• 1 other identifier: H17-01663
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia

Conditions

Diabetes; Sarcopenia; Hypotension, Orthostatic

Keywords

Diabetes; Sarcopenia; Hypotension; Tilt Table Test

Outcome Measures

Primary Outcomes (6)

• Body composition

  Measured by DEXA Scan

  Change from months 0, 3 and 6 months post insulin start

• Grip strength

  measured by Hand Dynamometer

  Change from months 0, 3 and 6 months post insulin start

• Physical functioning Survey

  measured by the Physical Component Summary from the SF-12 Health

  Change from months 0, 3 and 6 months post insulin start

• Presence or absence of orthostatic hypotension

  Drop in systolic blood pressure of greater than 20 mmHg after 3 minutes of standing

  Change from months 0, 3 and 6 months post insulin start

• Nadir of systolic blood pressure during the Tilt Table Test

  Lowest systolic blood pressure obtained during the Tilt Table Test

  Change from months 0, 3 and 6 months post insulin start

• Nadir of diastolic blood pressure during the Tilt Table Test

  Lowest diastolic blood pressure obtained during the Tilt Table Test

  Change from months 0, 3 and 6 months post insulin start

Secondary Outcomes (2)

• Nadir of middle cerebral artery velocity as measured by transcranial doppler

  Change from months 0, 3 and 6 months post insulin start

• Presence or absence of a positive Tilt Table Test (vasovagal syncope)

  Change from months 0, 3 and 6 months post insulin start

Study Arms (1)

Type 2 Diabetes, Insulin Naive

Study participants will be tested prior to and 3 and 6 months after starting insulin to manage their diabetes

Drug: Insulin Lispro

Interventions

Insulin Lispro DRUG

Insulin

Also known as: Humalog

Type 2 Diabetes, Insulin Naive

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults age 65 and older with type 2 diabetes who do not use insulin to manage their diabetes.

You may qualify if:

• years of age or older
• Type 2 diabetes for at least 5 years
• Insulin naive
• now needs insulin to manage diabetes

You may not qualify if:

• anemia as defined by serum hematocrit
• 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

Sponsors & Collaborators

• Kenneth Madden: lead

Study Sites (1)

University of British Columbia - Gerontology Research Lab

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (22)

• 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.

  PMID: 25455530 BACKGROUND

• 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.

  PMID: 27262494 BACKGROUND

• 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.

  PMID: 24070944 BACKGROUND

• 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.

  PMID: 23537893 BACKGROUND

• 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.

  PMID: 23196814 BACKGROUND

• 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.

  PMID: 15569132 BACKGROUND

• 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.

  PMID: 20721344 BACKGROUND

• 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.

  PMID: 9791738 BACKGROUND

• 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.

  PMID: 17904451 BACKGROUND

• 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.

  PMID: 17118224 BACKGROUND

• 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.

  PMID: 9500557 BACKGROUND

• 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.

  PMID: 8522054 BACKGROUND

• 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.

  PMID: 11230783 BACKGROUND

• 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.

  PMID: 3090090 BACKGROUND

• 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.

  PMID: 12766740 BACKGROUND

• 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.

  PMID: 1638718 BACKGROUND

• 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.

  PMID: 18716048 BACKGROUND

• 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.

  PMID: 27568020 BACKGROUND

• 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.

  PMID: 1563252 BACKGROUND

• 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.

  PMID: 16129869 BACKGROUND

• 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.

  PMID: 12164986 BACKGROUND

• 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.

  PMID: 10926954 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Sarcopenia; Hypotension, Orthostatic; Hypotension

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Madden M Kenneth, MD

  University of British Columbia/Gerontology Research Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, UBC Department of Medicine

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 14, 2017
• Study Start: October 1, 2017
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)