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Completed

NCT Number: NCT05662930

Evaluation Of Stress Response In Diabetic Hypertensive Patients

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Istanbul University

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Female gender
  • Patients younger than 40 years old or older than 65 years old
  • Uncontrolled blood pressure (SBP>140 mmHg, DBP>90 mmHg)
  • Using antipsychotic medication
  • Using current treatment for less than 3 months
  • Having a previous MI
  • Having a previous stroke
  • Having a lung disease
  • Having organ failure
  • Having Cushing's disease
  • Having aldosteronism
  • Failure to sign the informed consent form

Treatment and study plan

First arithmetic problem solving

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

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

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

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

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

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.

Primary outcomes

  1. Cortisol

    Time frame: Baseline

    A saliva sample is collected for cortisol evaluation

  2. Cortisol

    Time frame: 30 minutes after beginning

    A saliva sample is collected

  3. Cortisol

    Time frame: 45 minutes after beginning

    A saliva sample is collected

  4. Cortisol

    Time frame: 60 minutes after beginning

    A saliva sample is collected

  5. Blood pressure

    Time frame: Baseline

    The patient is rested by sitting before the measurement

  6. Blood pressure

    Time frame: 15 minutes after beginning measurement

    The patient is rested by sitting before the measurement

  7. Blood pressure

    Time frame: 35 minutes after beginning measurement

    The patient is rested by sitting before the measurement

  8. Blood pressure

    Time frame: 50 minutes after beginning measurement

    The patient is rested by sitting before the measurement

  9. Blood pressure

    Time frame: 75 minutes after beginning measurement

    The patient is rested by sitting before the measurement

  10. Aldosterone

    Time frame: Baseline

    Venous blood sample is collected

  11. Heart Rate

    Time frame: Beginning

    The patient is rested by sitting before the measurement

  12. Heart Rate

    Time frame: 15 minutes after beginning

    The patient is rested by sitting before the measurement

  13. Heart Rate

    Time frame: 35 minutes after beginning

    The patient is rested by sitting before the measurement

  14. Heart Rate

    Time frame: 50 minutes after beginning

    The patient is rested by sitting before the measurement

  15. Heart Rate

    Time frame: 75 minutes after beginning

    The patient is rested by sitting before the measurement

Secondary outcomes

  1. Mental state examination

    Time frame: Baseline

    Mini Mental State Examination - MMSE is used to evaluate the mental state

  2. Physical activity

    Time frame: Baseline

    International Physical Activity Questionnaire is used to evaluate the level of physical activity

  3. Health related Quality of life

    Time frame: Baseline

    SF-36 v2 is used to evaluate the health related quality of life

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 23, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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