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

Association of Perceived Stress and Negative Thoughts With Metabolic Biomarkers and Inflammatory Diseases 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Guilty feelings

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Coahuila De Zaragoza
    • Torreón, Coahuila De Zaragoza, Mexico, 27000
      • Facultad de medicina De la UADEC Unidad Torreón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guilty feelings; Write for 20 minutes about a situation that in the participant's past life has caused feelings of guilt.	Behavioral: Guilty feelings; Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.
Placebo Comparator: Neutral feelings; Write for 20 minutes about a situation that in the participant's past life has caused neutral feelings.	Behavioral: Guilty feelings; Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels	mg/dL	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.
Salivary cortisol	mg/dL	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.
Salivary Tumor Necrosis Factor alpha	mg/dL	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress	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.	This variable is measured in a single day and represents the week prior to the study.
Negative thoughts	Automatic negative thoughts scale (ATQ-N), range 0-90. Higher scores mean a worse outcome (more negative thoughts).	This variable is measured in a single day and represents the month prior to the study.
Depression	Beck's Depression Inventory, range 0-63. Higher number indicating more severe depression.	This variable is measured in a single day and represents the week prior to the study.

Collaborators and Investigators

• Sponsor: Francisco Carlos López Marquez
• Investigators: Principal Investigator: Francisco C. López Marquez, PhD, Universidad Autonoma de Coahuila, Centro de investigación Biomédica

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): August 25, 2017
• Study Completion (Actual): August 25, 2017

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Diabetes; Stress; Negative thoughts
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: C.B/02-01-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No