Clinical trial NCT06264661: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sleep quality
timeFrame: 0 and 3 months
measure: Glycosylated hemoglobin
timeFrame: 0 and 3 months
measure: Quality of life
timeFrame: 0 and 3 months
measure: Insomnia
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Gene expression analysis of CLOCK
timeFrame: 0 and 3 months
measure: Gene expression analysis of BMAL1
timeFrame: 0 and 3 months
measure: Gene expression analysis of PER1
timeFrame: 0 and 3 months
measure: Gene expression analysis of PER2
timeFrame: 0 and 3 months
Other outcomes:
Locations:
city: Cdmx
country: Mexico
facility: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás
state: México
Study officials:
References: