NCT01914146

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2018

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

July 22, 2013

Last Update Submit

January 8, 2018

Conditions

Orthostatic HypotensionDiabetesSyncope

Keywords

DiabetesInsulinOrthostatic HypotensionFallsSyncope

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 1. The nadir of middle cerebral artery (MCA) velocity

    1 day

  • 2. The presence or absence of a positive augmented tilt table test

    1 day

  • 3. The nadir of systolic blood pressure (SBP) and diastolic blood pressure (DBP) during tilt table test.

    1 day

Study Arms (2)

Before Initiation of Insulin Therapy

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.

Other: No Insulin

After 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.

Other: Insulin

Interventions

InsulinOTHER

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.

Also known as: Lantus
After Initiation of Insulin Therapy
No InsulinOTHER

Study session will occur prior to initiation of insulin therapy.

Before Initiation of Insulin Therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerontology Research Lab, Dept. of Medicine, Vancouver Coastal Health Research Institute, VGH Research Pavilion, Room 186-828 West 10th Avenue

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Hypotension, OrthostaticDiabetes MellitusSyncopeInsulin Resistance

Interventions

InsulinInsulin Glargine

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

  • Kenneth M Madden, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2013

First Posted

August 1, 2013

Study Start

April 1, 2015

Primary Completion

January 2, 2018

Study Completion

January 2, 2018

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)