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

NCT ID: NCT04387045

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2017-08-25

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Guilty feelings

Write for 20 minutes about a situation that in the participant's past life has caused feelings of guilt.

Group Type: EXPERIMENTAL

Guilty feelings

Intervention Type: BEHAVIORAL

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

Neutral feelings

Write for 20 minutes about a situation that in the participant's past life has caused neutral feelings.

Group Type: PLACEBO_COMPARATOR

Guilty feelings

Intervention Type: BEHAVIORAL

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

Interventions

Guilty feelings

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Francisco Carlos López Marquez

OTHER

Sponsor Role: lead

Responsible Party

Francisco Carlos López Marquez

Director of Biomedical research center, Faculty of Medicine, Torreón unit.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francisco C. López Marquez, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Autonoma de Coahuila, Centro de investigación Biomédica

Locations

Facultad de medicina De la UADEC Unidad Torreón

Torreón, Coahuila, Mexico

Countries

Mexico

Other Identifiers

C.B/02-01-17

Identifier Type: -

Identifier Source: org_study_id