Clinical trial NCT05662930: Evaluation Of Stress Response In Diabetic Hypertensive Patients
Official title: Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypertension
Keywords: Diabetes mellitus
Hypertension
Cortisol
Stress
Aldosterone
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 62
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cortisol
timeFrame: Baseline
measure: Cortisol
timeFrame: 30 minutes after beginning
measure: Cortisol
timeFrame: 45 minutes after beginning
measure: Cortisol
timeFrame: 60 minutes after beginning
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 15 minutes after beginning measurement
measure: Blood pressure
timeFrame: 35 minutes after beginning measurement
measure: Blood pressure
timeFrame: 50 minutes after beginning measurement
measure: Blood pressure
timeFrame: 75 minutes after beginning measurement
measure: Aldosterone
timeFrame: Baseline
measure: Heart Rate
timeFrame: Beginning
measure: Heart Rate
timeFrame: 15 minutes after beginning
measure: Heart Rate
timeFrame: 35 minutes after beginning
measure: Heart Rate
timeFrame: 50 minutes after beginning
measure: Heart Rate
timeFrame: 75 minutes after beginning
Secondary outcomes:
measure: Mental state examination
timeFrame: Baseline
measure: Physical activity
timeFrame: Baseline
measure: Health related Quality of life
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Iliriana Alloqi Tahirbegolli, Prof.Ass.Dr.
role: PRINCIPAL_INVESTIGATOR
References: