Orthostatic HypotensionODETNCT00807976
Orthostatic Hypotension and Diabetes Mellitus
An observational study of Orthostatic Hypotension and Diabetes Mellitus Type 2, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Hypotension, Diabetes Mellitus Type 2
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Type 2 diabetic patients aged 70 years and older
Who may be able to join
- diabetes mellitus
- age (70 years and older)
Who cannot join
- Known autonomic dysfunction
- Neurodegenerative diseases
- Current malignancy
- Living in a nursing-home
- Irregular pulse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Orthostatic Hypotension, Diabetes Mellitus Type 2
- Keywords
- Diabetes mellitus, Elderly, Orthostatic hypotension
- Medical subject headings
- Hypotension, Orthostatic, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of orthostatic hypotension
Measured: 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)
Secondary outcomes (1)
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
Measured: 1-12 months (the outcome measures are assessed only once during the running time of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Investigators
- Kornelis JJ van Hateren, MD, Principal investigator, Diabetes centre, Isala Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807976
- Sponsor's protocol ID
- ODET1
- Acronym
- ODET
- Status last verified
- Oct 2010
- First submitted
- 11 Dec 2008
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Orthostatic Hypotension in the Diabetic Elderly Patients Trial (ODET)
- ClinicalTrials.gov ID
- NCT00807976
- Acronym / sponsor ID
- ODET / ODET1
- Conditions
- Orthostatic Hypotension, Diabetes Mellitus Type 2
- Keywords
- Diabetes mellitus, Elderly, Orthostatic hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Type 2 diabetic patients aged 70 years and older
Key inclusion criteria (2 listed)
- diabetes mellitus
- age (70 years and older)
Key exclusion criteria (5 listed)
- Known autonomic dysfunction
- Neurodegenerative diseases
- Current malignancy
- Living in a nursing-home
- Irregular pulse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of orthostatic hypotension
Time frame: 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kornelis JJ van Hateren, MD principal investigator
Diabetes centre, Isala Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Hypotension and Diabetes Mellitus Type 2, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of orthostatic hypotension (time frame: 1-12 months (orthostatic blood pressure is assessed only once during the running time of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2010.