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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Gene expression analysis of BMAL1 |
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Inclusion Criteria:
Have a medical record in the Endocrinology service at the Hospital Juarez de Mexico
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás | Mexico City | Mexico City | 11360 | Mexico |
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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.
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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 | 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 | 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D006442 | Glycated Hemoglobin |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000093422 | Glycated Serum Proteins |
| D000093844 | Glycated Proteins |
| D017127 | Glycation End Products, Advanced |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D006023 | Glycoproteins |
| D006454 | Hemoglobins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005914 | Globins |
| D006420 | Hemeproteins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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