Insulin Therapy and Falls Due to Orthostatic Hypotension

Diabetes Clinical Trial

Official title:

Insulin Therapy and Falls Due to Orthostatic Hypotension (Pilot Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01914146
• Other study ID #: H13-01375
• Status: Withdrawn
• Phase: N/A
• First received: July 22, 2013
• Last updated: January 8, 2018
• Start date: April 2015
• Est. completion date: January 2, 2018

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Syncope

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Presence or absence of orthostatic hypotension	defined as a drop in systolic blood pressure greater than 20 mmHg after 3 minutes upright standing	1 day
Secondary	1. The nadir of middle cerebral artery (MCA) velocity	lowest middle cerebral artery flow velocity determined by transcranial Doppler	1 day
Secondary	2. The presence or absence of a positive augmented tilt table test	The augmented tilt table test will occur after receiving 300 µg nitroglycerin (GTN), and is a recognized method of testing for risk of vasovagal syncope. The tilt table will be considered positive and aborted prior to the 20 minutes if the subjects have a syncopal spell or demonstrate presyncopal (lightheadedness) symptoms in association with a 30 mm Hg drop in systolic blood pressure.	1 day
Secondary	3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.	lowest systolic blood pressure and diastolic blood pressure during tilt table tests and when they occur.	1 day