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Orthostatic Hypotension | Insulin Therapy and Falls Due to Orthostatic Hypotension

Orthostatic Hypotension research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Orthostatic Hypotension

Diabetes

Syncope

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:InsulinInitiation 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.

Other:No InsulinStudy session will occur prior to initiation of insulin therapy.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Before Initiation of Insulin TherapyStudy 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.

After Initiation of Insulin TherapyStudy 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.

Study Status

Recruiting

Start Date: April 2015

Completed Date: July 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 1. Presence or absence of orthostatic hypotension

Secondary Outcome: 1. The nadir of middle cerebral artery (MCA) velocity

Study sponsors, principal investigator, and references

Principal Investigator: Kenneth M Madden, MD

Lead Sponsor: University of British Columbia

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01914146

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