Evaluation Of Stress Response In Diabetic Hypertensive Patients

NCT ID: NCT05662930

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-09-04

Brief Summary

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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

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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.

Conditions

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Diabetes Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertension + Diabetes Mellitus (HT+DM)

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

First arithmetic problem solving

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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:

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

First arithmetic problem solving

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Iliriana Alloqi Tahirbegolli

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iliriana Alloqi Tahirbegolli, Prof.Ass.Dr.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Alloqi Tahirbegolli I, Tahirbegolli B, Sen S, Sayin B, Kaskal M, Uresin AY. Evaluation of Stress Response in Middle-Aged Male Diabetic Hypertensive Patients. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2307-2314. doi: 10.1210/clinem/dgad122.

Reference Type DERIVED
PMID: 36880261 (View on PubMed)

Other Identifiers

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22939

Identifier Type: -

Identifier Source: org_study_id

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