Effects of Insulin on Hypotension and Sarcopenia

January 10, 2023 updated by: Kenneth Madden
In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • University of British Columbia - Gerontology Research Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • Humalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Change from months 0, 3 and 6 months post insulin start
Measured by DEXA Scan
Change from months 0, 3 and 6 months post insulin start
Grip strength
Time Frame: Change from months 0, 3 and 6 months post insulin start
measured by Hand Dynamometer
Change from months 0, 3 and 6 months post insulin start
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
Change from months 0, 3 and 6 months post insulin start
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
Change from months 0, 3 and 6 months post insulin start
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
Change from months 0, 3 and 6 months post insulin start
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
Change from months 0, 3 and 6 months post insulin start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from months 0, 3 and 6 months post insulin start
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
Change from months 0, 3 and 6 months post insulin start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Madden

Investigators

  • Principal Investigator: Madden M Kenneth, MD, University of British Columbia/Gerontology Research Lab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

January 10, 2023

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-01663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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