Insulin Therapy and Falls Due to Orthostatic Hypotension

University of British Columbia

Status: Withdrawn

Conditions: Syncope; Diabetes; Orthostatic Hypotension

Treatments: Other: Insulin; Other: No Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT01914146

H13-01375

Details and patient eligibility

About

In the proposed study, the investigators examine in older adults with Type 2 diabetes the impact of beginning insulin therapy on the orthostatic drop in blood pressure as well as the response of arterial blood pressure and Doppler measures of cerebral blood flow during upright tilt. The investigators hypothesize that in older adults with Type 2 diabetes, the cardiovascular effects of insulin would precipitate or worsen orthostatic intolerance not present at baseline.

Full description

Before and 2 weeks after the start of standard insulin therapy several tests will be done:

• orthostatic hypotension will be tested for with 3 orthostatic maneuvers
• vasovagal syncope will be tested with 2 tilt table tests, one augmented with 400ug of nitroglycerin
• MCA velocity will be measured with a transcranial doppler
• Heart Rate and Blood Pressure will be measured throughout the test with a Finometer and Power Lab on a beat to beat basis

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All subjects must be 65 years of age or older
• All must have been diagnosed with Type 2 diabetes for at least 5 years
• All subjects must be insulin-naïve on recruitment
• All subjects must be eligible to start insulin therapy (long or intermediate acting) as determined by their diabetologist

Exclusion criteria

• Anemia, as determined by serum hematocrit
• Abnormal liver function tests
• Elevated creatinine
• Smoker
• Musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Before Initiation of Insulin Therapy

Other group

Description:

Study sessions will occur before the initiation of insulin therapy (no insulin). Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.

Treatment:

Other: No Insulin

After Initiation of Insulin Therapy

Other group

Description:

Study session will take place 2-4 weeks after the initiation of insulin therapy. Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.

Treatment:

Other: Insulin