Type 2 DiabetesNCT06264661

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

A study testing Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia in people with Type 2 Diabetes, run by Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 60 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia
Type of treatment: Lifestyle or therapy programme
How many people: 23 participants
Where: 1 siteMexico
Study dates: 8 Aug 2022to 30 Nov 2022
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 40 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás
Mexico City, Mexico City, 11360

Other trials in Mexico

About this study

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.

Conditions: Type 2 Diabetes
Being tested: Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomniaBehavioural
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep quality
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.
Measured: 0 and 3 months
Glycosylated hemoglobin
A venous blood sample will be taken and analyzed in the clinical analysis laboratory.
Measured: 0 and 3 months
Quality of life
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)
Measured: 0 and 3 months
Insomnia
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
Measured: 0 and 3 months

Secondary outcomes (4)

Gene expression analysis of CLOCK
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.
Measured: 0 and 3 months
Gene expression analysis of BMAL1
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.
Measured: 0 and 3 months
Gene expression analysis of PER1
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.
Measured: 0 and 3 months
Gene expression analysis of PER2
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.
Measured: 0 and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 202230 Nov 2022

First posted20 Feb 2024
Study start8 Aug 2022
Primary completion30 Sep 2022
Study completion30 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 DiabetesStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: 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 outwith validated instruments for Mexican population and gene expression was evaluated by real-time PCR.
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06264661
Sponsor's protocol ID: HJM 006/22-R
Status last verified: Feb 2024
First submitted: 22 Jan 2024
Last updated: 20 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06264661
Acronym / sponsor ID: HJM 006/22-R
Conditions: Type 2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo TomásUniversity, hospital or other
Study start: 8 Aug 2022 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 30 Nov 2022 (actual)
First posted: 20 Feb 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Model description: 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 outwith validated instruments for Mexican population and gene expression was evaluated by real-time PCR.

Who may qualify

Ages: 40 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (5 listed)

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)

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
Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomniaClinical, 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.	Behavioural	–

Primary outcome

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.
Glycosylated hemoglobin
Time frame: 0 and 3 months
A venous blood sample will be taken and analyzed in the clinical analysis laboratory.
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)
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

4 secondary outcomes

Gene expression analysis of CLOCK
Time frame: 0 and 3 months
Gene expression analysis of BMAL1
Time frame: 0 and 3 months
Gene expression analysis of PER1
Time frame: 0 and 3 months
Gene expression analysis of PER2
Time frame: 0 and 3 months

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 20 Feb 2024.

Related trials for Type 2 Diabetes

RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
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Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruiting
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Type 2 Diabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 20 Feb 2024. 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. 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?

Sleep quality (time frame: 0 and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06264661.

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 20 Feb 2024.