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DiabetesNCT03248271

Effects of Insulin on Hypotension and Sarcopenia

An observational study of Diabetes and Sarcopenia, run by Kenneth Madden at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 65 years and older
Conditions the study is for
Diabetes, Sarcopenia, Hypotension, Orthostatic
What is being tested?
Insulin Lispro
How many people
0 participants
Where
1 siteCanada
Study dates
1 Oct 2017to 10 Jan 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of British Columbia - Gerontology Research Lab

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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

Read the detailed description

Diabetes is common in the elderly. By the age of 70, approximately 25% of the population has diabetes and another 25% is at risk for diabetes. Elderly patients with diabetes are at increased risk for disability and reduction in their instrumental and basic activities of daily living. The prevalence of frailty is higher in people with diabetes that with age matched controls without diabetes. One of the major contributing factors to frailty is sarcopenia.

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.

Being tested
Insulin Lispro
Keywords
Diabetes, Sarcopenia, Hypotension, Tilt Table Test
Medical subject headings
Diabetes Mellitus, Sarcopenia, Hypotension, Orthostatic, Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin LisproDrug

    Also called Humalog

    Insulin

Study groups in NCT03248271
Study groupRoleWhat they receive
Type 2 Diabetes, Insulin NaiveStudy participants will be tested prior to and 3 and 6 months after starting insulin to manage their diabetes
Receives: Drug: Insulin Lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body composition

    Measured by DEXA Scan

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

  2. Grip strength

    measured by Hand Dynamometer

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

  3. Physical functioning Survey

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

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

  4. Presence or absence of orthostatic hypotension

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

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

  5. Nadir of systolic blood pressure during the Tilt Table Test

    Lowest systolic blood pressure obtained during the Tilt Table Test

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

  6. Nadir of diastolic blood pressure during the Tilt Table Test

    Lowest diastolic blood pressure obtained during the Tilt Table Test

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

Secondary outcomes (2)

  1. Nadir of middle cerebral artery velocity as measured by transcranial doppler

    Lowest middle cerebral artery velocity obtained during the Tilt Table Test

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

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

    Sudden drop in blood pressure and heart rate that leads to fainting

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study start1 Oct 2017
  3. Primary completion10 Jan 2023
  4. Study completion10 Jan 2023

Why it stopped: Study design was changed to the study was changed to Insulin, hypotension and sarcopenia.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248271
Sponsor's protocol ID
H17-01663
Status last verified
Jan 2023
First submitted
7 Aug 2017
Last updated
12 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25455530

  • 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.

    PubMed 27262494

  • 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.

    PubMed 24070944

  • 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.

    PubMed 23537893

  • 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.

    PubMed 23196814

  • 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.

    PubMed 15569132

  • 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.

    PubMed 20721344

  • 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.

    PubMed 9791738

  • 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.

    PubMed 17904451

  • 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.

    PubMed 17118224

  • 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.

    PubMed 9500557

  • 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.

    PubMed 8522054

  • 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.

    PubMed 11230783

  • 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.

    PubMed 3090090

  • 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.

    PubMed 12766740

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Sarcopenia, run by Kenneth Madden at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition (time frame: Change from months 0, 3 and 6 months post insulin start). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03248271, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.

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