Skip to main content
OpenTrials
Completed

NCT Number: NCT04387045

Perceived Stress and Negative Thoughts With Biomarkers in People With Type 2 Diabetes Mellitus and Healthy Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Behavioral Symptoms Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de medicina De la UADEC Unidad Torreón

Torreón, Coahuila, 27000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Guilty feelings

Behavioral

Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.

Primary outcomes

  1. Glucose levels

    Time frame: 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

  2. Salivary cortisol

    Time frame: 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

  3. Salivary Tumor Necrosis Factor alpha

    Time frame: 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 outcomes

  1. Perceived stress

    Time frame: 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.

  2. Negative thoughts

    Time frame: 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).

  3. Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Francisco Carlos López Marquez

Other

Registry information

Official study title

Association of Perceived Stress and Negative Thoughts With Metabolic Biomarkers and Inflammatory Diseases in People With Type 2 Diabetes Mellitus and Healthy Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 13, 2020
Registry last updated
May 15, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.