Orthostatic Hypotension and Diabetes Mellitus (ODET)

October 7, 2010 updated by: Medical Research Foundation, The Netherlands

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 8000 GM
        • Diabetes centre, isala clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 diabetic patients aged 70 years and older

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group
Type 2 diabetic patients aged 70 years and older.
Control group
Patients aged 70 years and older, with no history of type 2 diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Foundation, The Netherlands

Investigators

  • Principal Investigator: Kornelis JJ van Hateren, MD, Diabetes centre, isala clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 11, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODET1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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