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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06264661
• Other study ID #: HJM 006/22-R
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2024
• Source: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
Mexico	Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás	Cdmx	México

Sponsors (1)

Lead Sponsor	Collaborator
Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 and 3 months
Primary	Glycosylated hemoglobin	A venous blood sample will be taken and analyzed in the clinical analysis laboratory.	0 and 3 months
Primary	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)	0 and 3 months
Primary	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	0 and 3 months
Secondary	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.	0 and 3 months
Secondary	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.	0 and 3 months
Secondary	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.	0 and 3 months
Secondary	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.	0 and 3 months