Orthostatic Hypotension and Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

— ODET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807976
• Other study ID #: ODET1
• Status: Completed
• Phase: N/A
• First received: December 11, 2008
• Last updated: October 7, 2010
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2010
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Locations

Country	Name	City	State
Netherlands	Diabetes centre, Isala Clinics	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of orthostatic hypotension		1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)	No
Secondary	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)	No