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Evaluation Of Stress Response In Diabetic Hypertensive Patients

Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05662930
Enrollment
62
Registered
2022-12-23
Start date
2016-06-01
Completion date
2018-09-04
Last updated
2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hypertension

Keywords

Diabetes mellitus, Hypertension, Cortisol, Stress, Aldosterone

Brief 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. 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.

Interventions

BEHAVIORALFirst arithmetic problem solving

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.

BEHAVIORALSecond arithmetic problem solving

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.

BEHAVIORALThird arithmetic problem solving

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.

BEHAVIORALFourth arithmetic problem solving

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.

BEHAVIORALFifth arithmetic problem solving

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.

BEHAVIORALSixth arithmetic problem solving

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.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Female gender 2. Patients younger than 40 years old or older than 65 years old 3. Uncontrolled blood pressure (SBP\>140 mmHg, DBP\>90 mmHg) 4. Using antipsychotic medication 5. Using current treatment for less than 3 months 6. Having a previous MI 7. Having a previous stroke 8. Having a lung disease 9. Having organ failure 10. Having Cushing's disease 11. Having aldosteronism 12. Failure to sign the informed consent form

Design outcomes

Primary

MeasureTime frameDescription
CortisolBaselineA saliva sample is collected for cortisol evaluation
Blood pressureBaselineThe patient is rested by sitting before the measurement
AldosteroneBaselineVenous blood sample is collected
Heart RateBeginningThe patient is rested by sitting before the measurement

Secondary

MeasureTime frameDescription
Physical activityBaselineInternational Physical Activity Questionnaire is used to evaluate the level of physical activity
Health related Quality of lifeBaselineSF-36 v2 is used to evaluate the health related quality of life
Mental state examinationBaselineMini Mental State Examination - MMSE is used to evaluate the mental state

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026