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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00807976
Other study ID # ODET1
Secondary ID
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


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
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