Orthostatic Hypotension and Diabetes Mellitus

The Orthostatic Hypotension in the Diabetic Elderly Patients Trial (ODET)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00807976

Acronym

ODET

Enrollment

500

Registered

2008-12-15

Start date

2009-01-31

Completion date

2010-05-31

Last updated

2010-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Orthostatic Hypotension

Keywords

Diabetes mellitus, Elderly, Orthostatic hypotension

Brief summary

Rationale: Orthostatic hypotension increases with age and is associated with increased vascular and all-cause mortality. The prevalence of orthostatic hypotension is also increased in diabetic subjects. In order to prevent related adverse events and vascular mortality it is of great interest to examine the prevalence of orthostatic hypotension in elderly diabetic subjects. Objective: To examine the prevalence of orthostatic hypotension and associated adverse events in type 2 diabetic elderly subjects. Study design: Cross-sectional observational study. Study population: Elderly type 2 diabetic subjects (70 years and older).

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* diabetes mellitus * age (70 years and older)

Exclusion criteria

* Known autonomic dysfunction * Neurodegenerative diseases * Current malignancy * Living in a nursing-home * Irregular pulse

Design outcomes

Primary

Measure	Time frame
Prevalence of orthostatic hypotension	1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)

Secondary

Measure	Time frame
Adverse events, Score risk profile questionnaire, Heart rate, Gender, Body mass index, Medication, Smoking, History of cardiovascular disease, Family history of cardiovascular disease, Duration of diabetes mellitus, Glycosylated haemoglobin, Insulin use	1-12 months (the outcome measures are assessed only once during the running time of the study)

Countries

Netherlands

Outcome results