Orthostatic Hypotension and Diabetes Mellitus (ODET)
|ClinicalTrials.gov Identifier: NCT00807976|
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : October 8, 2010
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).
|Condition or disease|
|Orthostatic Hypotension Diabetes Mellitus Type 2|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||The Orthostatic Hypotension in the Diabetic Elderly Patients Trial (ODET)|
|Study Start Date :||January 2009|
|Primary Completion Date :||May 2010|
|Study Completion Date :||May 2010|
Type 2 diabetic patients aged 70 years and older.
Patients aged 70 years and older, with no history of type 2 diabetes mellitus.
- Prevalence of orthostatic hypotension [ Time Frame: 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study) ]
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807976
|Diabetes centre, Isala Clinics|
|Zwolle, Netherlands, 8000 GM|
|Principal Investigator:||Kornelis JJ van Hateren, MD||Diabetes centre, Isala Clinics|