Diabetes Mellitus, Type 2NCT04387045
Perceived Stress and Negative Thoughts With Biomarkers in People With Type 2 Diabetes Mellitus and Healthy Subjects
A study testing Guilty feelings in people with Diabetes Mellitus, Type 2, run by Francisco Carlos López Marquez at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Guilty feelings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 2 May 2017to 25 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Facultad de medicina De la UADEC Unidad Torreón
Torreón, Coahuila, 27000
About this study
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
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.
Read the 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
- Being tested
- Guilty feelings
- Keywords
- Diabetes, Depression, Stress, Negative thoughts
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guilty feelingsBehavioural
Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.
| Study group | Role | What they receive |
|---|---|---|
| Guilty feelings | Experimental | Write for 20 minutes about a situation that in the participant's past life has caused feelings of guilt. Receives: 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. Receives: Behavioral: Guilty feelings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
mg/dL
Measured: 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
Measured: 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
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: This variable is measured in a single day and represents the week prior to the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start2 May 2017
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Carlos López Marquez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Carlos López Marquez, Universidad Autonoma de Coahuila
- Investigators
- Francisco C. López Marquez, PhD, Principal investigator, Universidad Autonoma de Coahuila, Centro de investigación Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387045
- Sponsor's protocol ID
- C.B/02-01-17
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04387045
- Acronym / sponsor ID
- C.B/02-01-17
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Depression, Stress, Negative thoughts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Francisco Carlos López MarquezUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guilty feelings | Experimental | Behavioral: Guilty feelingsWrite for 20 minutes about a situation that in the participant's past life has caused feelings of guilt. |
| Neutral feelings | Placebo comparator | Behavioral: Guilty feelingsWrite for 20 minutes about a situation that in the participant's past life has caused neutral feelings. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guilty feelingsParticipants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives. | Behavioural | Guilty feelings, Neutral feelings |
Primary outcome
Glucose levels
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.
mg/dL
Salivary cortisol
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.
mg/dL
Salivary Tumor Necrosis Factor alpha
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.
mg/dL
3 secondary outcomes
Perceived stress
Time frame: This variable is measured in a single day and represents the week prior to the study.
Negative thoughts
Time frame: This variable is measured in a single day and represents the month prior to the study.
Depression
Time frame: This variable is measured in a single day and represents the week prior to the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco C. López Marquez, PhD principal investigator
Universidad Autonoma de Coahuila, Centro de investigación Biomédica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guilty feelings in people with Diabetes Mellitus, Type 2, run by Francisco Carlos López Marquez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose levels (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.