Clinical trial NCT03248271: Effects of Insulin on Hypotension and Sarcopenia
Official title: Effects of Insulin on Hypotension and Sarcopenia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Sarcopenia
Hypotension, Orthostatic
Keywords: Diabetes
Sarcopenia
Hypotension
Tilt Table Test
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Body composition
timeFrame: Change from months 0, 3 and 6 months post insulin start
measure: Grip strength
timeFrame: Change from months 0, 3 and 6 months post insulin start
measure: Physical functioning Survey
timeFrame: Change from months 0, 3 and 6 months post insulin start
measure: Presence or absence of orthostatic hypotension
timeFrame: Change from months 0, 3 and 6 months post insulin start
measure: Nadir of systolic blood pressure during the Tilt Table Test
timeFrame: Change from months 0, 3 and 6 months post insulin start
measure: Nadir of diastolic blood pressure during the Tilt Table Test
timeFrame: Change from months 0, 3 and 6 months post insulin start
Secondary outcomes:
measure: Nadir of middle cerebral artery velocity as measured by transcranial doppler
timeFrame: Change from months 0, 3 and 6 months post insulin start
measure: Presence or absence of a positive Tilt Table Test (vasovagal syncope)
timeFrame: Change from months 0, 3 and 6 months post insulin start
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia - Gerontology Research Lab
state: British Columbia
Study officials:
affiliation: University of British Columbia/Gerontology Research Lab
name: Madden M Kenneth, MD
role: PRINCIPAL_INVESTIGATOR
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