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Effects of Insulin on Hypotension and Sarcopenia

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ClinicalTrials.gov Identifier: NCT03248271
Recruitment Status : Withdrawn (Study design was changed to the study was changed to Insulin, hypotension and sarcopenia.)
First Posted : August 14, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth Madden, University of British Columbia

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

Condition or disease Intervention/treatment
Diabetes Sarcopenia Hypotension, Orthostatic Drug: Insulin Lispro

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Insulin on Hypotension and Sarcopenia
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Insulin
Other Name: Humalog




Primary Outcome Measures :
  1. Body composition [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    Measured by DEXA Scan

  2. Grip strength [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    measured by Hand Dynamometer

  3. Physical functioning Survey [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    measured by the Physical Component Summary from the SF-12 Health

  4. Presence or absence of orthostatic hypotension [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    Drop in systolic blood pressure of greater than 20 mmHg after 3 minutes of standing

  5. Nadir of systolic blood pressure during the Tilt Table Test [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    Lowest systolic blood pressure obtained during the Tilt Table Test

  6. Nadir of diastolic blood pressure during the Tilt Table Test [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    Lowest diastolic blood pressure obtained during the Tilt Table Test


Secondary Outcome Measures :
  1. Nadir of middle cerebral artery velocity as measured by transcranial doppler [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    Lowest middle cerebral artery velocity obtained during the Tilt Table Test

  2. Presence or absence of a positive Tilt Table Test (vasovagal syncope) [ Time Frame: Change from months 0, 3 and 6 months post insulin start ]
    Sudden drop in blood pressure and heart rate that leads to fainting



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248271


Locations
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Canada, British Columbia
University of British Columbia - Gerontology Research Lab
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Kenneth Madden
Investigators
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Principal Investigator: Madden M Kenneth, MD University of British Columbia/Gerontology Research Lab
Publications:

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Responsible Party: Kenneth Madden, Associate Professor, UBC Department of Medicine, University of British Columbia
ClinicalTrials.gov Identifier: NCT03248271    
Other Study ID Numbers: H17-01663
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth Madden, University of British Columbia:
Diabetes
Sarcopenia
Hypotension
Tilt Table Test
Additional relevant MeSH terms:
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Sarcopenia
Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs