Evaluation Of Stress Response In Diabetic Hypertensive Patients
Diyabetik Hipertansif Hastalarda Stres Yanıtının Değerlendirilmesi
1 other identifier
observational
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2018
CompletedFirst Submitted
Initial submission to the registry
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedDecember 23, 2022
December 1, 2022
1.5 years
August 1, 2022
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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 Outcomes (3)
Mental state examination
Baseline
Physical activity
Baseline
Health related Quality of life
Baseline
Study Arms (2)
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
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
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University
Istanbul, 34000, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 36880261DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iliriana Alloqi Tahirbegolli, Prof.Ass.Dr.
Istanbul University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 1, 2022
First Posted
December 23, 2022
Study Start
June 1, 2016
Primary Completion
November 30, 2017
Study Completion
September 4, 2018
Last Updated
December 23, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share
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.