Orthostatic HypotensionNCT03732716
Sarcopenia and Orthostatic Hypotension
An observational study of Orthostatic Hypotension and Sarcopenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Hypotension, Sarcopenia
- What is being tested?
- blood pressure measurement
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2018to Dec 2018
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly patients ( 75 or older) with and without sarcopenia
Who may be able to join
- Patients 75 years or older
Who cannot join
- Pace-maker
- End stage renal insufficiency
- End stage malignancy
- Dehydration
- Severe anemia ( Hgb < 8 gr/dl)
- Acute infection
- Marked edema
- Neurodegenerative disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şişli Hamidiye Etfal Education and Research Hospital
Istanbul, 34200
Kudret Keskin, MD, 212 3735000 ext. 5188, keskinkudret@yahoo.com
About this study
Official title: The Relationship Between Sarcopenia and Orthostatic Hypotension
Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.
- Conditions
- Orthostatic Hypotension, Sarcopenia
- Being tested
- blood pressure measurement
- Keywords
- blood pressure, elderly, sarcopenia, fall
- Medical subject headings
- Hypotension, Orthostatic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurementDiagnostic test
Intervention: Each patient's supine and standing blood pressure measurements will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Elderly with sarcopenia | 50 patients aged 75 or older with sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured. Receives: Diagnostic Test: blood pressure measurement | |
| Elderly without sarcopenia | 50 patients aged 75 or older without sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured. Receives: Diagnostic Test: blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
All blood pressure measurements will be performed in the morning after an eight-hour fasting. After 5-minute rest, the first blood pressure measurement will be taken when the patients are supine. Later, three more consecutive measurements will be recorded when the patients stand up each being one-minute apart. All measurements will be performed using a fully automated sphygmomanometer that is attached with the correctly sized cuff matching to the patients' upper arm circumference. OH is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing. The accompanying symptoms such as dizziness, unable to maintain balance, blurred vision will also be recorded.
Measured: 0-3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start10 Sep 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kudret Keskin, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Kadriye Orta Kılıçkesmez, Prof, Study director, Şişli Hamidiye Etfal Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732716
- Sponsor's protocol ID
- 2052
- Status last verified
- Nov 2018
- First submitted
- 6 Sep 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashimoto Y, Kaji A, Sakai R, Hamaguchi M, Okada H, Ushigome E, Asano M, Yamazaki M, Fukui M. Sarcopenia is associated with blood pressure variability in older patients with type 2 diabetes: A cross-sectional study of the KAMOGAWA-DM cohort study. Geriatr Gerontol Int. 2018 Sep;18(9):1345-1349. doi: 10.1111/ggi.13487. Epub 2018 Jul 24.
PubMed 30039599
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sarcopenia and Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT03732716
- Acronym / sponsor ID
- 2052
- Conditions
- Orthostatic Hypotension, Sarcopenia
- Keywords
- blood pressure, elderly, sarcopenia, fall
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 7 Nov 2018 (actual)
- 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.
Elderly patients generally have a tendency for having sarcopenia which refers to muscle loss that may be related to many factors. These patients also have a tendency to falls and injuries. Whether elderly sarcopenic patients have abrupt blood pressure drops upon standing remains unknown. Therefore, in this study, we sought to determine the incidence of orthostatic hypotension in sarcopenic elderly patients and compare it with elderly patients with no sarcopenia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly with sarcopenia | – | Diagnostic Test: blood pressure measurement50 patients aged 75 or older with sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured. |
| Elderly without sarcopenia | – | Diagnostic Test: blood pressure measurement50 patients aged 75 or older without sarcopenia Intervention: Each patient's supine and standing blood pressures will be measured. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly patients ( 75 or older) with and without sarcopenia
Key inclusion criteria (1 listed)
- Patients 75 years or older
Key exclusion criteria (8 listed)
- Pace-maker
- End stage renal insufficiency
- End stage malignancy
- Dehydration
- Severe anemia ( Hgb < 8 gr/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressure measurementIntervention: Each patient's supine and standing blood pressure measurements will be recorded | Diagnostic test | Elderly with sarcopenia, Elderly without sarcopenia |
Primary outcome
Change in blood pressure
Time frame: 0-3 minutes
All blood pressure measurements will be performed in the morning after an eight-hour fasting. After 5-minute rest, the first blood pressure measurement will be taken when the patients are supine. Later, three more consecutive measurements will be recorded when the patients stand up each being one-minute apart. All measurements will be performed using a fully automated sphygmomanometer that is attached with the correctly sized cuff matching to the patients' upper arm circumference. OH is defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing. The accompanying symptoms such as dizziness, unable to maintain balance, blurred vision will also be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 30039599Hashimoto Y, Kaji A, Sakai R, Hamaguchi M, Okada H, Ushigome E, Asano M, Yamazaki M, Fukui M. Sarcopenia is associated with blood pressure variability in older patients with type 2 diabetes: A cross-sectional study of the KAMOGAWA-DM cohort study. Geriatr Gerontol Int. 2018 Sep;18(9):1345-1349. doi: 10.1111/ggi.13487. Epub 2018 Jul 24.
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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.
Kadriye Orta Kılıçkesmez, Prof study director
Şişli Hamidiye Etfal Education and Research Hospital
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 Sarcopenia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Nov 2018. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kudret Keskin, MD (0212 3735000 ext. 5188, keskinkudret@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: 0-3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03732716, which also lists 1 linked publication.
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 7 Nov 2018.