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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Guilty feelings

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Depression, Stress, Negative thoughts

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Facultad de medicina De la UADEC Unidad Torreón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Guilty feelings

Neutral feelings

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glucose levels

mg/dL

Salivary cortisol

mg/dL

Salivary Tumor Necrosis Factor alpha

mg/dL

Secondary Outcome Measures

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.

Negative thoughts

Automatic negative thoughts scale (ATQ-N), range 0-90. Higher scores mean a worse outcome (more negative thoughts).

Depression

Beck's Depression Inventory, range 0-63. Higher number indicating more severe depression.

Full Information

NCT ID

NCT04387045

First Posted

May 9, 2020

Last Updated

May 13, 2020

Sponsor

Francisco Carlos López Marquez

1. Study Identification

Unique Protocol Identification Number

NCT04387045

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 2, 2017 (Actual)

Primary Completion Date

August 25, 2017 (Actual)

Study Completion Date

August 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Francisco Carlos López Marquez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Diabetes, Depression, Stress, Negative thoughts

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Guilty feelings

Arm Type

Experimental

Arm Description

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

Arm Title

Neutral feelings

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Guilty feelings

Intervention Description

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

Primary Outcome Measure Information:

Title

Glucose levels

Description

mg/dL

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.

Title

Salivary cortisol

Description

mg/dL

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.

Title

Salivary Tumor Necrosis Factor alpha

Description

mg/dL

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.

Secondary Outcome Measure Information:

Title

Perceived stress

Description

Time Frame

This variable is measured in a single day and represents the week prior to the study.

Title

Negative thoughts

Description

Automatic negative thoughts scale (ATQ-N), range 0-90. Higher scores mean a worse outcome (more negative thoughts).

Time Frame

This variable is measured in a single day and represents the month prior to the study.

Title

Depression

Description

Beck's Depression Inventory, range 0-63. Higher number indicating more severe depression.

Time Frame

This variable is measured in a single day and represents the week prior to the study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco C. López Marquez, PhD

Organizational Affiliation

Universidad Autonoma de Coahuila, Centro de investigación Biomédica

Official's Role

Principal Investigator

Facility Information:

Facility Name

Facultad de medicina De la UADEC Unidad Torreón

City

Torreón

State/Province

Coahuila De Zaragoza

ZIP/Postal Code

27000

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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