Evaluation Of Stress Response In Diabetic Hypertensive Patients

Hypertension Clinical Trial

Official title:

Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05662930
• Other study ID #: 22939
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: September 4, 2018

Study information

• Verified date: December 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 4, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol	A saliva sample is collected for cortisol evaluation	Baseline
Primary	Cortisol	A saliva sample is collected	30 minutes after beginning
Primary	Cortisol	A saliva sample is collected	45 minutes after beginning
Primary	Cortisol	A saliva sample is collected	60 minutes after beginning
Primary	Blood pressure	The patient is rested by sitting before the measurement	Baseline
Primary	Blood pressure	The patient is rested by sitting before the measurement	15 minutes after beginning measurement
Primary	Blood pressure	The patient is rested by sitting before the measurement	35 minutes after beginning measurement
Primary	Blood pressure	The patient is rested by sitting before the measurement	50 minutes after beginning measurement
Primary	Blood pressure	The patient is rested by sitting before the measurement	75 minutes after beginning measurement
Primary	Aldosterone	Venous blood sample is collected	Baseline
Primary	Heart Rate	The patient is rested by sitting before the measurement	Beginning
Primary	Heart Rate	The patient is rested by sitting before the measurement	15 minutes after beginning
Primary	Heart Rate	The patient is rested by sitting before the measurement	35 minutes after beginning
Primary	Heart Rate	The patient is rested by sitting before the measurement	50 minutes after beginning
Primary	Heart Rate	The patient is rested by sitting before the measurement	75 minutes after beginning
Secondary	Mental state examination	Mini Mental State Examination - MMSE is used to evaluate the mental state	Baseline
Secondary	Physical activity	International Physical Activity Questionnaire is used to evaluate the level of physical activity	Baseline
Secondary	Health related Quality of life	SF-36 v2 is used to evaluate the health related quality of life	Baseline