Orthostatic Hypotension and Diabetes Mellitus

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).

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Key information

Conditions

Orthostatic Hypotension Autonomic Nervous System Diseases Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypotension Hypotension, Orthostatic Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Orthostatic Intolerance Primary Dysautonomias Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes centre, Isala Clinics

Zwolle, 8000 GM, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Prevalence of orthostatic hypotension

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

Secondary outcomes

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

Time frame: 1-12 months (the outcome measures are assessed only once during the running time of the study)

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Registry information

Official study title

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

Acronym: ODET

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Dec 15, 2008
Registry last updated: Oct 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed