Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Depression, Stress, Negative thoughts
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.
Interventions
BEHAVIORALGuilty feelings
Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.
Sponsors
Francisco Carlos López Marquez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose levels | 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. | mg/dL |
| Salivary cortisol | 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. | mg/dL |
| Salivary Tumor Necrosis Factor alpha | 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. | mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived stress | This variable is measured in a single day and represents the week prior to the study. | Perceived stress scale (PSS-14), range 0-40.Higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. |
| Negative thoughts | This variable is measured in a single day and represents the month prior to the study. | Automatic negative thoughts scale (ATQ-N), range 0-90. Higher scores mean a worse outcome (more negative thoughts). |
| Depression | This variable is measured in a single day and represents the week prior to the study. | Beck's Depression Inventory, range 0-63. Higher number indicating more severe depression. |
Countries
Mexico
Outcome results
None listed