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

NCT06264661 | Completed DMC

• 1 other identifier: HJM 006/22-R
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• 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

• Glycosylated hemoglobin

  A venous blood sample will be taken and analyzed in the clinical analysis laboratory.

  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)

  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

  0 and 3 months

Secondary Outcomes (4)

• Gene expression analysis of CLOCK

  0 and 3 months

• Gene expression analysis of BMAL1

  0 and 3 months

• Gene expression analysis of PER1

  0 and 3 months

• Gene expression analysis of PER2

  0 and 3 months

Interventions

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 BEHAVIORAL

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

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás: lead

Study Sites (1)

Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás

Mexico City, Mexico City, 11360, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Phototherapy; Glycated Hemoglobin; Quality of Life

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Glycated Serum Proteins; Glycated Proteins; Glycation End Products, Advanced; Glycoconjugates; Carbohydrates; Glycoproteins; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins; Toxins, Biological; Biological Factors; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and researcher

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 20, 2024
• Study Start: August 8, 2022
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

ME (1)