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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 25, 2017

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

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

Arms, Groups and Cohorts

  • Experimental: Guilty feelings
    • Write for 20 minutes about a situation that in the participant’s past life has caused feelings of guilt.
  • Placebo Comparator: Neutral feelings
    • Write for 20 minutes about a situation that in the participant’s past life has caused neutral feelings.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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 Measures

  • 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.
  • 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).
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Francisco Carlos López Marquez
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Francisco Carlos López Marquez, Director of Biomedical research center, Faculty of Medicine, Torreón unit. – Universidad Autonoma de Coahuila
  • Overall Official(s)
    • Francisco C. López Marquez, PhD, Principal Investigator, Universidad Autonoma de Coahuila, Centro de investigación Biomédica

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