DiabetesNCT05662930
Evaluation Of Stress Response In Diabetic Hypertensive Patients
An observational study of Diabetes and Hypertension, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this research, we aimed to examine salivary cortisol changes in the cognitive stress response of patients with Hypertension + Diabetes Mellitus (HT+DM) and Hypertension (HT) and to determine the differences between them. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- First arithmetic problem solving, Second arithmetic problem solving and Third arithmetic problem solving
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2016to 4 Sep 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of patients in the register of the pharmacology clinic of the faculty of medicine who have a diagnosis of hypertension and diabetes mellitus type 2.
Who may be able to join
- Using antihypertensive treatment for the last 3 months
- Diagnosed with Type 2 Diabetes Mellitus and taking medication for at least 3 months
- Being between the ages of 40-65
- Being male
- Having signed the informed consent form
Who cannot join
- Female gender
- Patients younger than 40 years old or older than 65 years old
- Uncontrolled blood pressure (SBP>140 mmHg, DBP>90 mmHg)
- Using antipsychotic medication
- Using current treatment for less than 3 months
- Having a previous MI
Show all 12Show fewer
- Having a previous stroke
- Having a lung disease
- Having organ failure
- Having Cushing's disease
- Having aldosteronism
- Failure to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi
In this research, we aimed to examine salivary cortisol changes in the cognitive stress response of patients with Hypertension + Diabetes Mellitus (HT+DM) and Hypertension (HT) and to determine the differences between them.
The research was conducted by solving an arithmetic task as a stress test in 62 patients with HT+DM and HT that are being treated in the outpatient clinic of Medical Pharmacology and Clinical Pharmacology Department at Istanbul University, Istanbul Medical Faculty Hospital.
Read the detailed description
In this study, saliva samples were taken for cortisol measurement, and patients were instructed to place the cotton piece in the salivette® tubes directly into their mouths without touching it with anything, hold it for 30-60 seconds, and then insert it back into the tubes in the same way, four times total, once before arithmetic stress and three times after stress, on Tuesdays, Wednesdays, and Thursdays between the hours of 12:00-16:00.
Salivary cortisol was measured using the electro-chemiluminescence immunoassay.
- Conditions
- Diabetes, Hypertension
- Being tested
- First arithmetic problem solving, Second arithmetic problem solving, Third arithmetic problem solving, Fourth arithmetic problem solving, Fifth arithmetic problem solving
- Keywords
- Diabetes mellitus, Hypertension, Cortisol, Stress, Aldosterone
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First arithmetic problem solvingBehavioural
In a quiet environment, a white paper in A4 format was placed in front of the patient on the table, and the patients were asked to subtract the number 3 from 2907 for 100 seconds.
The researcher was standing in front of the patient and asks to make corrections by giving a warning whenever the patient made a mistake in the calculation.
Second arithmetic problem solvingBehavioural
In the same A4-sized white paper that was placed in front of each patient on a table, immediately after the first subtraction process, patients were asked to subtract 7 from 6828 for another 100 seconds.
When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning.
Third arithmetic problem solvingBehavioural
In the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 13 from 9561 for another 100 seconds.
When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning.
Fourth arithmetic problem solvingBehavioural
In the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 8 from 5113 for another 100 seconds.
When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning.
Fifth arithmetic problem solvingBehavioural
In the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 14 from 8318 for another 100 seconds.
When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning.
Sixth arithmetic problem solvingBehavioural
In the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 17 from 9994 for another 100 seconds.
When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension + Diabetes Mellitus (HT+DM) | Patients who fulfilled the following criteria were included in this group:
1. Using antihypertensive treatment for the last 3 months
2. Diagnosed with Type 2 Diabetes Mellitus and taking medication for at least 3 months
3. Being between the ages of 40-65
4. Being male
5. Having signed the informed consent form Receives: Behavioral: First arithmetic problem solving; Behavioral: Second arithmetic problem solving; Behavioral: Third arithmetic problem solving; Behavioral: Fourth arithmetic problem solving; Behavioral: Fifth arithmetic problem solving; Behavioral: Sixth arithmetic problem solving | |
| Hypertension (HT) | Patients who fulfilled the following criteria were included in this group:
1. Using antihypertensive treatment for the last 3 months
2. Being between the ages of 40-65
3. Being male
4. Having signed the informed consent form Receives: Behavioral: First arithmetic problem solving; Behavioral: Second arithmetic problem solving; Behavioral: Third arithmetic problem solving; Behavioral: Fourth arithmetic problem solving; Behavioral: Fifth arithmetic problem solving; Behavioral: Sixth arithmetic problem solving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
A saliva sample is collected for cortisol evaluation
Measured: Baseline
Cortisol
A saliva sample is collected
Measured: 30 minutes after beginning
Cortisol
A saliva sample is collected
Measured: 45 minutes after beginning
Cortisol
A saliva sample is collected
Measured: 60 minutes after beginning
Blood pressure
The patient is rested by sitting before the measurement
Measured: Baseline
Blood pressure
The patient is rested by sitting before the measurement
Measured: 15 minutes after beginning measurement
Blood pressure
The patient is rested by sitting before the measurement
Measured: 35 minutes after beginning measurement
Blood pressure
The patient is rested by sitting before the measurement
Measured: 50 minutes after beginning measurement
Blood pressure
The patient is rested by sitting before the measurement
Measured: 75 minutes after beginning measurement
Aldosterone
Venous blood sample is collected
Measured: Baseline
Heart Rate
The patient is rested by sitting before the measurement
Measured: Beginning
Heart Rate
The patient is rested by sitting before the measurement
Measured: 15 minutes after beginning
Heart Rate
The patient is rested by sitting before the measurement
Measured: 35 minutes after beginning
Heart Rate
The patient is rested by sitting before the measurement
Measured: 50 minutes after beginning
Heart Rate
The patient is rested by sitting before the measurement
Measured: 75 minutes after beginning
Secondary outcomes (3)
Mental state examination
Mini Mental State Examination - MMSE is used to evaluate the mental state
Measured: Baseline
Physical activity
International Physical Activity Questionnaire is used to evaluate the level of physical activity
Measured: Baseline
Health related Quality of life
SF-36 v2 is used to evaluate the health related quality of life
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jun 2016
- Primary completion30 Nov 2017
- Study completion4 Sep 2018
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iliriana Alloqi Tahirbegolli, Istanbul University
- Investigators
- Iliriana Alloqi Tahirbegolli, Prof.Ass.Dr., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662930
- Sponsor's protocol ID
- 22939
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on the regulations it is not mandatory for this study to share the individual data of patients. But in the case of a proper request by researchers the data can be shared by the principal researcher of the study.
Publications
Alloqi Tahirbegolli I, Tahirbegolli B, Sen S, Sayin B, Kaskal M, Uresin AY. Evaluation of Stress Response in Middle-Aged Male Diabetic Hypertensive Patients. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2307-2314. doi: 10.1210/clinem/dgad122.
PubMed 36880261
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi
- ClinicalTrials.gov ID
- NCT05662930
- Acronym / sponsor ID
- 22939
- Conditions
- Diabetes, Hypertension
- Keywords
- Diabetes mellitus, Hypertension, Cortisol, Stress, Aldosterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 23 Dec 2022 (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.
In this research, we aimed to examine salivary cortisol changes in the cognitive stress response of patients with Hypertension + Diabetes Mellitus (HT+DM) and Hypertension (HT) and to determine the differences between them.
The research was conducted by solving an arithmetic task as a stress test in 62 patients with HT+DM and HT that are being treated in the outpatient clinic of Medical Pharmacology and Clinical Pharmacology Department at Istanbul University, Istanbul Medical Faculty Hospital.
Detailed description
In this study, saliva samples were taken for cortisol measurement, and patients were instructed to place the cotton piece in the salivette® tubes directly into their mouths without touching it with anything, hold it for 30-60 seconds, and then insert it back into the tubes in the same way, four times total, once before arithmetic stress and three times after stress, on Tuesdays, Wednesdays, and Thursdays between the hours of 12:00-16:00.
Salivary cortisol was measured using the electro-chemiluminescence immunoassay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension + Diabetes Mellitus (HT+DM) | – | Behavioral: First arithmetic problem solving, Behavioral: Second arithmetic problem solving, Behavioral: Third arithmetic problem solving, Behavioral: Fourth arithmetic problem solving, Behavioral: Fifth arithmetic problem solving, Behavioral: Sixth arithmetic problem solvingPatients who fulfilled the following criteria were included in this group: 1. Using antihypertensive treatment for the last 3 months 2. Diagnosed with Type 2 Diabetes Mellitus and taking medication for at least 3 months 3. Being between the ages of 40-65 4. Being male 5. Having signed the informed consent form |
| Hypertension (HT) | – | Behavioral: First arithmetic problem solving, Behavioral: Second arithmetic problem solving, Behavioral: Third arithmetic problem solving, Behavioral: Fourth arithmetic problem solving, Behavioral: Fifth arithmetic problem solving, Behavioral: Sixth arithmetic problem solvingPatients who fulfilled the following criteria were included in this group: 1. Using antihypertensive treatment for the last 3 months 2. Being between the ages of 40-65 3. Being male 4. Having signed the informed consent form |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients in the register of the pharmacology clinic of the faculty of medicine who have a diagnosis of hypertension and diabetes mellitus type 2.
Key inclusion criteria (5 listed)
- Using antihypertensive treatment for the last 3 months
- Diagnosed with Type 2 Diabetes Mellitus and taking medication for at least 3 months
- Being between the ages of 40-65
- Being male
- Having signed the informed consent form
Key exclusion criteria (12 listed)
- Female gender
- Patients younger than 40 years old or older than 65 years old
- Uncontrolled blood pressure (SBP>140 mmHg, DBP>90 mmHg)
- Using antipsychotic medication
- Using current treatment for less than 3 months
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 |
|---|---|---|
| First arithmetic problem solvingIn a quiet environment, a white paper in A4 format was placed in front of the patient on the table, and the patients were asked to subtract the number 3 from 2907 for 100 seconds. The researcher was standing in front of the patient and asks to make corrections by giving a warning whenever the patient made a mistake in the calculation. | Behavioural | Hypertension (HT), Hypertension + Diabetes Mellitus (HT+DM) |
| Second arithmetic problem solvingIn the same A4-sized white paper that was placed in front of each patient on a table, immediately after the first subtraction process, patients were asked to subtract 7 from 6828 for another 100 seconds. When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning. | Behavioural | Hypertension (HT), Hypertension + Diabetes Mellitus (HT+DM) |
| Third arithmetic problem solvingIn the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 13 from 9561 for another 100 seconds. When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning. | Behavioural | Hypertension (HT), Hypertension + Diabetes Mellitus (HT+DM) |
| Fourth arithmetic problem solvingIn the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 8 from 5113 for another 100 seconds. When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning. | Behavioural | Hypertension (HT), Hypertension + Diabetes Mellitus (HT+DM) |
| Fifth arithmetic problem solvingIn the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 14 from 8318 for another 100 seconds. When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning. | Behavioural | Hypertension (HT), Hypertension + Diabetes Mellitus (HT+DM) |
| Sixth arithmetic problem solvingIn the same A4-sized white paper that was placed in front of each patient on a table, immediately after the previous subtraction process, patients were asked to subtract 17 from 9994 for another 100 seconds. When the patient made a calculating error, the researcher stood in front of the patient and asked them to make corrections by issuing a warning. | Behavioural | Hypertension (HT), Hypertension + Diabetes Mellitus (HT+DM) |
Primary outcome
Cortisol
Time frame: Baseline
A saliva sample is collected for cortisol evaluation
Cortisol
Time frame: 30 minutes after beginning
A saliva sample is collected
Cortisol
Time frame: 45 minutes after beginning
A saliva sample is collected
Cortisol
Time frame: 60 minutes after beginning
A saliva sample is collected
Blood pressure
Time frame: Baseline
The patient is rested by sitting before the measurement
Blood pressure
Time frame: 15 minutes after beginning measurement
The patient is rested by sitting before the measurement
Blood pressure
Time frame: 35 minutes after beginning measurement
The patient is rested by sitting before the measurement
Blood pressure
Time frame: 50 minutes after beginning measurement
The patient is rested by sitting before the measurement
Blood pressure
Time frame: 75 minutes after beginning measurement
The patient is rested by sitting before the measurement
Aldosterone
Time frame: Baseline
Venous blood sample is collected
Heart Rate
Time frame: Beginning
The patient is rested by sitting before the measurement
Heart Rate
Time frame: 15 minutes after beginning
The patient is rested by sitting before the measurement
Heart Rate
Time frame: 35 minutes after beginning
The patient is rested by sitting before the measurement
Heart Rate
Time frame: 50 minutes after beginning
The patient is rested by sitting before the measurement
Heart Rate
Time frame: 75 minutes after beginning
The patient is rested by sitting before the measurement
3 secondary outcomes
Mental state examination
Time frame: Baseline
Physical activity
Time frame: Baseline
Health related Quality of life
Time frame: Baseline
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 23 Dec 2022.
- Derived from this study: PubMed 36880261Alloqi Tahirbegolli I, Tahirbegolli B, Sen S, Sayin B, Kaskal M, Uresin AY. Evaluation of Stress Response in Middle-Aged Male Diabetic Hypertensive Patients. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2307-2314. doi: 10.1210/clinem/dgad122.
- Individual participant dataSharing planned: No. Based on the regulations it is not mandatory for this study to share the individual data of patients. But in the case of a proper request by researchers the data can be shared by the principal researcher of the study.
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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.
Iliriana Alloqi Tahirbegolli, Prof.Ass.Dr. principal investigator
Istanbul 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 Diabetes and Hypertension, run by Istanbul 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 5 inclusion and 12 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 23 Dec 2022. 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?
Cortisol (time frame: Baseline). The study lists 15 primary outcomes in all. 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 NCT05662930, 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 23 Dec 2022.