NCT04387045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

May 9, 2020

Last Update Submit

May 13, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesDepressionStressNegative thoughts

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Perceived stress

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

  • Negative thoughts

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

  • Depression

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

Study Arms (2)

Guilty feelings

EXPERIMENTAL

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

Behavioral: Guilty feelings

Neutral feelings

PLACEBO COMPARATOR

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

Behavioral: Guilty feelings

Interventions

Guilty feelingsBEHAVIORAL

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

Guilty feelingsNeutral feelings

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written, informed consent.
  • to 65 years of age.
  • Current diagnosis of Diabetes mellitus type 2 without diabetic foot.
  • Healthy volunteers.
  • Ability to read and write.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de medicina De la UADEC Unidad Torreón

Torreón, Coahuila, 27000, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusDepression

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Francisco C. López Marquez, PhD

    Universidad Autonoma de Coahuila, Centro de investigación Biomédica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Biomedical research center, Faculty of Medicine, Torreón unit.

Study Record Dates

First Submitted

May 9, 2020

First Posted

May 13, 2020

Study Start

May 2, 2017

Primary Completion

August 25, 2017

Study Completion

August 25, 2017

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)