Evaluation Of Stress Response In Diabetic Hypertensive Patients

Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertension + Diabetes Mellitus (HT+DM); 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; 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.; Behavioral: Second 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.; Behavioral: Third 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.; Behavioral: Fourth 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.; Behavioral: Fifth 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.; Behavioral: Sixth 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.
Hypertension (HT); 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; 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.; Behavioral: Second 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.; Behavioral: Third 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.; Behavioral: Fourth 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.; Behavioral: Fifth 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.; Behavioral: Sixth 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Iliriana Alloqi Tahirbegolli, Prof.Ass.Dr., Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): September 4, 2018

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension; Stress; Cortisol; Diabetes mellitus; Aldosterone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 22939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Based on the regulations it is not mandatory for this study to share the individual data of patients. But in the case of a proper request by researchers the data can be shared by the principal researcher of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No