Evaluation Of Stress Response In Diabetic Hypertensive Patients

Completed

• Conditions: Diabetes; Hypertension

• 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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-11-30
• Study Completion: 2018-09-04
• Study First Submitted: 2022-08-01
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-20
• Last Update Submitted: 2022-12-20
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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