Clinical trial NCT04387045: Perceived Stress and Negative Thoughts With Biomarkers in People With Type 2 Diabetes Mellitus and Healthy Subjects
Official title: Association of Perceived Stress and Negative Thoughts With Metabolic Biomarkers and Inflammatory Diseases in People With Type 2 Diabetes Mellitus and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Depression
Stress
Negative thoughts
Lead sponsor: Universidad Autonoma de Coahuila
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of measured and induced negative feelings on glucose, tumor necrosis factor alpha, and cortisol levels in healthy participants and participants with type 2 diabetes mellitus.

Detailed description: Depression and Diabetes are two pathologies that are frequently comorbid. Stress and negative thoughts are part of both. The biological correlates of psychological and emotional life are not yet fully clarified, so in this study we wonder about the association between tumor necrosis factor alpha, cortisol, and peripheral glucose levels with depression stress, measured negative thoughts, and induced guilt.This is a randomized intervention study. At baseline, participants complete the Beck Depression Inventory, the Automatic Negative Thoughts Scale (ATQ-N), and the Perceived Stress Scale (PSS-14). The intervention consists of a written task about situations that involved feelings of guilt or neutral situations. Saliva and dextrostix samples are taken before the 20-minute written task, at the end, dextrostix and saliva samples are performed again, finally a blood sample is taken.

Eligibility criteria: Inclusion Criteria:

* Written, informed consent.
* 30 to 65 years of age.
* Current diagnosis of Diabetes mellitus type 2 without diabetic foot.
* Healthy volunteers.
* Ability to read and write.

Exclusion Criteria:

* Other current or past chronic disease diagnoses.
* Current use of antidepressants or other psychiatric medications.
* Steroid medication.
* Consumption of tobacco or alcohol in the last 24 hours.
* Previous diagnosis of autoimmune diseases

Primary outcomes:
measure: Glucose levels
timeFrame: Sample collection is two times during a single day for each participant, with an interval of 20 minutes. Since it will be measured in fasting, it will take place between 8:00 a.m. and 9:00 a.m.
measure: Salivary cortisol
timeFrame: Sample collection is two times during a single day for each participant, with an interval of 20 minutes. Since it will be measured in fasting, it will take place between 8:00 a.m. and 9:00 a.m.
measure: Salivary Tumor Necrosis Factor alpha
timeFrame: Sample collection is two times during a single day for each participant, with an interval of 20 minutes. It will take place between 8:00 a.m. and 9:00 a.m.
Secondary outcomes:
measure: Perceived stress
timeFrame: This variable is measured in a single day and represents the week prior to the study.
measure: Negative thoughts
timeFrame: This variable is measured in a single day and represents the month prior to the study.
measure: Depression
timeFrame: This variable is measured in a single day and represents the week prior to the study.
Other outcomes:
Locations:
city: Torreón
country: Mexico
facility: Facultad de medicina De la UADEC Unidad Torreón
state: Coahuila De Zaragoza
Study officials:
affiliation: Universidad Autonoma de Coahuila, Centro de investigación Biomédica
name: Francisco C. López Marquez, PhD
role: PRINCIPAL_INVESTIGATOR
References: