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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387045
• Other study ID #: C.B/02-01-17
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: August 25, 2017

Study information

• Verified date: May 2020
• Source: Universidad Autonoma de Coahuila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 25, 2017
• Est. primary completion date: August 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Mexico	Facultad de medicina De la UADEC Unidad Torreón	Torreón	Coahuila De Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Francisco Carlos López Marquez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.