Evaluation Of Stress Response In Diabetic Hypertensive Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi

Conditions
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Diabetes, Hypertension

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Having a previous stroke Having a lung disease Having organ failure Having Cushing's disease Having aldosteronism Failure to sign the informed consent form

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertension + Diabetes Mellitus (HT+DM)<br>Patients who fulfilled the following criteria were included in this group: 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 | Behavioral: First arithmetic problem solving<br>* 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.<br>Behavioral: Second arithmetic problem solving<br>* 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.<br>Behavioral: Third arithmetic problem solving<br>* 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.<br>Behavioral: Fourth arithmetic problem solving<br>* 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.<br>Behavioral: Fifth arithmetic problem solving<br>* 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.<br>Behavioral: Sixth arithmetic problem solving<br>* 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.<br>|
| Hypertension (HT)<br>Patients who fulfilled the following criteria were included in this group: Using antihypertensive treatment for the last 3 months Being between the ages of 40-65 Being male Having signed the informed consent form | Behavioral: First arithmetic problem solving<br>* 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.<br>Behavioral: Second arithmetic problem solving<br>* 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.<br>Behavioral: Third arithmetic problem solving<br>* 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.<br>Behavioral: Fourth arithmetic problem solving<br>* 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.<br>Behavioral: Fifth arithmetic problem solving<br>* 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.<br>Behavioral: Sixth arithmetic problem solving<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol | A saliva sample is collected for cortisol evaluation | Baseline | 
| Cortisol | A saliva sample is collected | 30 minutes after beginning | 
| Cortisol | A saliva sample is collected | 45 minutes after beginning | 
| Cortisol | A saliva sample is collected | 60 minutes after beginning | 
| Blood pressure | The patient is rested by sitting before the measurement | Baseline | 
| Blood pressure | The patient is rested by sitting before the measurement | 15 minutes after beginning measurement | 
| Blood pressure | The patient is rested by sitting before the measurement | 35 minutes after beginning measurement | 
| Blood pressure | The patient is rested by sitting before the measurement | 50 minutes after beginning measurement | 
| Blood pressure | The patient is rested by sitting before the measurement | 75 minutes after beginning measurement | 
| Aldosterone | Venous blood sample is collected | Baseline | 
| Heart Rate | The patient is rested by sitting before the measurement | Beginning | 
| Heart Rate | The patient is rested by sitting before the measurement | 15 minutes after beginning | 
| Heart Rate | The patient is rested by sitting before the measurement | 35 minutes after beginning | 
| Heart Rate | The patient is rested by sitting before the measurement | 50 minutes after beginning | 
| Heart Rate | The patient is rested by sitting before the measurement | 75 minutes after beginning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental state examination | Mini Mental State Examination - MMSE is used to evaluate the mental state | Baseline | 
| Physical activity | International Physical Activity Questionnaire is used to evaluate the level of physical activity | Baseline | 
| Health related Quality of life | SF-36 v2 is used to evaluate the health related quality of life | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Hypertension, Cortisol, Stress, Aldosterone