Postprandial HypotensionNCT06657287
Postprandial Hypotension and Insulin Levels
An observational study of Postprandial Hypotension and Hypoglycemia, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. The main question it aims to answer is: Is the incidence of postprandial hypotension high in patients who undergo mixed meal test? Is insulin level higher in individuals with… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hypotension, Hypoglycemia
- What is being tested?
- Mixed meal test
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2024to 1 Sep 2024
- How long will I take part?
- 1 Day
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital.
Who may be able to join
- Adults with postprandial symptoms
Who cannot join
- Individuals with prediabetes or diabetes,
- Those aged 65 and above,
- Patients using antihypertensive medications or with known hypertension,
- Those with active infections,
- Congestive heart failure,
- Peripheral artery disease,
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- Advanced-stage dementia,
- Individuals who could not provide a history or were unable to cooperate,
- Patients using medications that could induce hypoglycemia (oral antidiabetics, insulin, beta-blockers, hydroxychloroquine, bromocriptine, etc.)
- Those with conditions that could cause hypoglycemia (uncontrolled hypothyroidism, adrenal insufficiency, growth hormone deficiency, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: Relationship Between Insulin Levels and Postprandial Hypotension in the Standard Mixed Meal Test in Adults
The goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. The main question it aims to answer is:
Is the incidence of postprandial hypotension high in patients who undergo mixed meal test?
Is insulin level higher in individuals with postprandial hypotension compared to those without during a mixed meal test?
Patients with postprandial symptoms were scheduled for a mixed meal test, during which plasma glucose, insulin, C-peptide, blood pressure, and heart rate were measured at specific time points.
- Conditions
- Postprandial Hypotension, Hypoglycemia
- Being tested
- Mixed meal test
- Keywords
- Hypotension, hypoglycemia, insulin, mixed meal, adults, postprandial
- Medical subject headings
- Hypoglycemia, Hypotension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed meal testOther
The biochemical parameters, blood pressure, and heart rates of participants undergoing the mixed meal test will be recorded over a 5-hour period.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Adults with postprandial symptoms Receives: Other: Mixed meal test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
mmHg
Measured: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Blood glucose
mg/dL
Measured: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Blood insulin
uIU/mL
Measured: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Secondary outcomes (3)
Blood C-peptide
ng/mL
Measured: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Diastolic blood pressure
mmHg
Measured: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Heart rate
bpm
Measured: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start3 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Evra KARAKAYA, Ankara Yildirim Beyazıt University
- Investigators
- Rahime E Karakaya, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657287
- Sponsor's protocol ID
- AnkaraYBU-KARAKAYA004
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Insulin Levels and Postprandial Hypotension in the Standard Mixed Meal Test in Adults
- ClinicalTrials.gov ID
- NCT06657287
- Acronym / sponsor ID
- AnkaraYBU-KARAKAYA004
- Conditions
- Postprandial Hypotension, Hypoglycemia
- Keywords
- Hypotension, hypoglycemia, insulin, mixed meal, adults, postprandial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 24 Oct 2024 (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.
The goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. The main question it aims to answer is:
Is the incidence of postprandial hypotension high in patients who undergo mixed meal test?
Is insulin level higher in individuals with postprandial hypotension compared to those without during a mixed meal test?
Patients with postprandial symptoms were scheduled for a mixed meal test, during which plasma glucose, insulin, C-peptide, blood pressure, and heart rate were measured at specific time points.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: Mixed meal testAdults with postprandial symptoms |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital.
Key inclusion criteria (1 listed)
- Adults with postprandial symptoms
Key exclusion criteria (10 listed)
- Individuals with prediabetes or diabetes,
- Those aged 65 and above,
- Patients using antihypertensive medications or with known hypertension,
- Those with active infections,
- Congestive heart failure,
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 |
|---|---|---|
| Mixed meal testThe biochemical parameters, blood pressure, and heart rates of participants undergoing the mixed meal test will be recorded over a 5-hour period. | Other | Healthy adults |
Primary outcome
Systolic blood pressure
Time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
mmHg
Blood glucose
Time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
mg/dL
Blood insulin
Time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
uIU/mL
3 secondary outcomes
Blood C-peptide
Time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Diastolic blood pressure
Time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
Heart rate
Time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)
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 24 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Rahime E Karakaya, PhD principal investigator
Ankara Yildirim Beyazıt University
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 Postprandial Hypotension and Hypoglycemia, run by Ankara Yildirim Beyazıt University 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 10 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 24 Oct 2024. 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?
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?
Systolic blood pressure (time frame: During mixed meal test (baseline, 30., 60., 90., 120., 180., 240., 300. min)). The study lists 3 primary outcomes in all. 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 24 Oct 2024.