Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia

February 9, 2024 updated by: Nadia Mabel Pérez Vielma, Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás
Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • México
      • Cdmx, México, Mexico, 11360
        • Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Have a medical record in the Endocrinology service at the Hospital Juarez de Mexico

  • Patients with type 2 diabetes mellitus
  • Age between 40 and 60 years
  • Present Insomnia based on the criteria of The Diagnostic and Diagnostic Manual Statistics of Mental Disorders (DSM-V) which defines insomnia such as predominant dissatisfaction with the quantity or quality of sleep, associated with one (or more) of the following symptoms: a) Difficulty starting the dream,or b) Difficulty maintaining sleep, characterized by awakenings frequent and c) Waking up early in the morning with inability to return to sleep; with clinically significant distress or social impairment, work, educational, academic, behavioral or other important areas of operation, at least three nights a week, for a minimum of three months even with favorable sleeping conditions.
  • Sign an informed consent letter and agree to participate in the study.
  • Accept taking a blood sample pre and post intervention
  • HbA1c level above 6.1% (120 mg/dL;7 mmol/L) or BMI less than 34.9 units

Exclusion Criteria:

  • Do not agree to sign the informed consent
  • Have a previous psychiatric diagnosis
  • Have neurological disorders
  • Be diagnosed with type 1 diabetes mellitus or BMI greater than 35 units
  • Missing more than 20% of the sessions (2 sessions)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: 0 and 3 months
Pittsburg sleep quality questionnaire,It provides a global rating in 7 components, in no problem, good quality, poor quality and very poor quality of sleep, it consists of 19 multiple option items.
0 and 3 months
Glycosylated hemoglobin
Time Frame: 0 and 3 months
A venous blood sample will be taken and analyzed in the clinical analysis laboratory.
0 and 3 months
Quality of life
Time Frame: 0 and 3 months
Quality of life questionnaire D39, contains 39 closed items that are grouped into five sections: Energy-Mobility (15 items: 3, 7, 9, 10, 11, 12, 13, 16, 25, 29, 32, 33, 34, 35 and 36), Diabetes control (12 items: 1, 4, 5, 14, 15, 17, 18, 24, 27, 28, 31 and 39); Anxiety-worry (four items: 2, 6, 8 and 22), Social burden (five items: 19, 20, 26, 37 and 38) and Sexual functioning (three items: 21, 23 and 30)
0 and 3 months
Insomnia
Time Frame: 0 and 3 months
The Insomnia Scale Athens is made up of eight items, with a scale of Likert type with four response options that ranges of 0 (no sleep-related problem) to 3 (high presence of sleep problems). The first five items identify insomnia and the last three are aimed at identifying consequences of insomnia to the next day
0 and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gene expression analysis of CLOCK
Time Frame: 0 and 3 months
The determination of gene expression is carried out through the Trizol technique and real-time Polymerase Chain Reaction (PCR-RT) in a 4 ml blood sample taken in tubes with EDTA.
0 and 3 months
Gene expression analysis of BMAL1
Time Frame: 0 and 3 months
The determination of gene expression is carried out through the Trizol technique and real-time Polymerase Chain Reaction (PCR-RT) in a 4 ml blood sample taken in tubes with EDTA.
0 and 3 months
Gene expression analysis of PER1
Time Frame: 0 and 3 months
The determination of gene expression is carried out through the Trizol technique and real-time Polymerase Chain Reaction (PCR-RT) in a 4 ml blood sample taken in tubes with EDTA.
0 and 3 months
Gene expression analysis of PER2
Time Frame: 0 and 3 months
The determination of gene expression is carried out through the Trizol technique and real-time Polymerase Chain Reaction (PCR-RT) in a 4 ml blood sample taken in tubes with EDTA.
0 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HJM 006/22-R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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