Evaluation Of Stress Response In Diabetic Hypertensive Patients
- Conditions
- DiabetesHypertension
- Interventions
- Behavioral: First arithmetic problem solvingBehavioral: Second arithmetic problem solvingBehavioral: Third arithmetic problem solvingBehavioral: Fourth arithmetic problem solvingBehavioral: Fifth arithmetic problem solvingBehavioral: Sixth arithmetic problem solving
- Registration Number
- NCT05662930
- Lead Sponsor
- Istanbul University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hypertension + Diabetes Mellitus (HT+DM) First arithmetic problem solving 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 Hypertension + Diabetes Mellitus (HT+DM) Second arithmetic problem solving 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 Hypertension (HT) Fourth arithmetic problem solving 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 Hypertension + Diabetes Mellitus (HT+DM) Fourth arithmetic problem solving 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 Hypertension (HT) Third arithmetic problem solving 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 Hypertension + Diabetes Mellitus (HT+DM) Third arithmetic problem solving 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 Hypertension + Diabetes Mellitus (HT+DM) Fifth arithmetic problem solving 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 Hypertension (HT) Second arithmetic problem solving 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 Hypertension (HT) Sixth arithmetic problem solving 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 Hypertension + Diabetes Mellitus (HT+DM) Sixth arithmetic problem solving 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 Hypertension (HT) First arithmetic problem solving 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 Hypertension (HT) Fifth arithmetic problem solving 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
- Primary Outcome Measures
Name Time Method Cortisol 60 minutes after beginning A saliva sample is collected
Blood pressure 75 minutes after beginning measurement The patient is rested by sitting before the measurement
Aldosterone Baseline Venous blood sample is collected
Heart Rate 75 minutes after beginning The patient is rested by sitting before the measurement
- Secondary Outcome Measures
Name Time Method Physical activity Baseline International Physical Activity Questionnaire is used to evaluate the level of physical activity
Mental state examination Baseline Mini Mental State Examination - MMSE is used to evaluate the mental state
Health related Quality of life Baseline SF-36 v2 is used to evaluate the health related quality of life
Trial Locations
- Locations (1)
Istanbul University
🇹🇷Istanbul, Turkey
Istanbul University🇹🇷Istanbul, Turkey