Overview

Conditions orthostatic hypotension, diabetes, syncope
Treatments insulin, no insulin
Sponsor University of British Columbia
Start date April 2015
End date September 2017
Trial size 45 participants
Trial identifier NCT01914146, H13-01375

Summary

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries Canada

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
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.
no insulin
Study session will occur prior to initiation of insulin therapy.
(Other)
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.
insulin Lantus
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.

Primary Outcomes

Measure
1. Presence or absence of orthostatic hypotension
time frame: 1 day

Secondary Outcomes

Measure
1. The nadir of middle cerebral artery (MCA) velocity
time frame: 1 day
2. The presence or absence of a positive augmented tilt table test
time frame: 1 day
3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.
time frame: 1 day

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)
Principal investigator Kenneth M Madden, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.