Insomnia´s Impact on DNA Stability, Cardio-metabolic Health and Lifestyle Behaviors

NCT06869486 | Recruiting

• 1 other identifier: CEEIP0004-FDE
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is a highly prevalent sleep disorder worldwide, with an increasing incidence in athletes, older adults, university students, and individuals with metabolic syndrome. This disorder has been associated with metabolic dysfunction, cardiovascular diseases, and genetic instability. Recent evidence suggests that insomnia negatively impacts cardiorespiratory fitness, insulin sensitivity, and overall health through mechanisms involving neuroendocrine dysregulation, oxidative stress, and alterations in energy metabolism. However, the specific biological and environmental factors that contribute to its prevalence and health consequences remain poorly understood, particularly across different populations. Understanding these associations is crucial for developing effective prevention and intervention strategies to mitigate the long-term impact of insomnia. Therefore, this study aims to analyze the impact of insomnia on body composition, cardiorespiratory fitness, metabolic flexibility, and DNA integrity, across populations with high prevalence of insomnia, including athletes, older adults, university students, and individuals with metabolic syndrome. This study will also investigate which biological and lifestyle behaviors contribute to insomnia and its health consequences. By doing so, this work will provide critical insights into the physiological and molecular mechanisms that link insomnia with metabolic and cardiovascular dysfunction, contributing to the development of targeted interventions for at-risk populations

Conditions

Insomnia; Cardiorespiratory Fitness; Metabolic Disease

Keywords

Physical Activity; Physical Fitness; DNA integrity; Endocrinology and Metabolism

Outcome Measures

Primary Outcomes (16)

• Insomnia severity index

  A Spanish version of the insomnia severity index scale will be applied to examine the absence or presence of clinical insomnia. This five-item scale provides a range score between 0-28 that is interpreted as follows: * 0-7= No clinically significant insomnia * 8-14 subthreshold insomnia * 15-21 Clinical insomnia (moderate severity) * 22-28 Clinical insomnia (severe)

  Day 1

• Daytime sleepiness

  A Spanish version of the Epworth Sleepiness Scale will be applied to examine day-time sleepiness. This is an 8-items self-administered questionnaire that provides a range score between 0-24, interpreted as follows: * 0-5 Lower Normal Daytime Sleepiness * 6-10 Higher Normal Daytime Sleepiness * 11-12 Mild Excessive Daytime Sleepiness * 13-15 Moderate Excessive Daytime Sleepiness * 16-24 Severe Excessive Daytime Sleepiness

  Day 1

• Sleep quality Index

  A Spanish version of the Pittsburgh Sleep Quality Index scale will be applied to examine sleep quality. This 9-item scale provides a range score between 0-21 that is interpreted as follows: \*\<5 good sleep quality \*\>5 poor sleep quality

  Day 1

• Body composition

  Bioelectrical impedance analysis (BIA) will be used to measure the components of the body, including fat mass (kg, %), lean mass (kg, %), muscle mass (kg), visceral adipose tissue area (cm2), phase angle (°), and total body water (L), through a mechanism of resistance and reactance. A multi-frequency device (1-1000 kHz), with 8-point Tactile Electrode System will be used for this measurements (InBody 770, KOR). This system also provides a segmental analysis of fat mass (kg, %), and lean mass (kg, %) (right/left arms or legs, and trunk). A body composition score, ranging from 0-100, will be retrieved from a predetermined algorithm provided by the fabricant.

  Day 1

• DNA integrity

  The frequency of micronuclei, nuclear buds, basal cells, binucleated cells, condensed chromatin cells, karyorrhexis, karyolysis, and pyknosis will be determined through microscopic examination of exfoliated oral mucosal cells from each participant.

  Day 1

• OPN4 Single nucleotide polymorphism

  The P10L polymorphism of the OPN4 gene, previously associated with chronic insomnia and severe daytime sleepiness in the Mexican population will be determined using RFLP-PCR assays. DNA will be extracted from previously collected blood samples (4 ml) using the Master Pure DNA purification kit from Epicentre (Illumina Inc., US).

  Day 1

• Cardiorespiratory fitness

  A cardiopulmonary exercise test in a treadmill will be performed after an overnight fasting. Gas exchange, heart rate, and muscle oxygen saturation levels will be assessed continuously during the entire test. Blood pressure and rate of perceived exertion will be recorded prior the end of each stage whereas blood glucose concentration will be assessed before and after the test. All the hemodynamic parameters will be assessed at rest to standardize the cardio-metabolic condition of the participants prior to exercise testing. Maximal exertion will be requested from all participants except elders, in whom a submaximal test will be applied, following the guidelines provided by the American College of Sports Medicine. From this trial, maximal oxygen uptake, ventilatory thresholds/dynamics, chronotropic and inotropic response, and will be examined. A trained exercise physiologist will supervise all the tests and validate the obtained data.

  Day 1

• Metabolic flexibility

  A cardiopulmonary exercise test in a treadmill will be performed after an overnight fasting. Gas exchange will be assessed continuously during the entire test to determine fat and carbohydrate oxidation. The maximal rate of fat oxidation, its shape and area under the curve will be defined in conjunction with the workload at which carbohydrates become the predominant energy source (cross over point). The increase in fat oxidation from rest to exercise will be also relativized to the change in energy expenditure to characterize metabolic flexibility. Resting metabolic rate and respiratory quotient will be also assessed at rest to standardize the metabolic condition of the participants prior to exercise testing. A trained exercise physiologist will supervise all the tests and validate the obtained data.

  Day 1

• Homeostatic Model Assessment of Insulin Resistance

  The serum concentrations of glucose and insulin will be determined under fasting conditions, using a blood chemistry analyzer (Spin120, Spinreact, ESP), and enzyme-linked immunosorbent assays (ELISA) on a microplate reader (iMark, BIORAD, USA) . Serum samples will be obtained by centrifuging peripheral venous blood samples collected in vacutainer tubes under fasting conditions (4-6 mL; 2500 rpm for 10 minutes). The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be then calculated with the following equation: HOMA-IR = glucose (mg/dL) x insulin (uU/mL) / 405

  Day 1

• Cholesterol

  Total cholesterol (mg/dL) will be will be assessed in a blood chemistry analyzer (Spin120, Spinreact, ESP). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes under fasting conditions (4-6 mL; 2500 rpm for 10 minutes).

  Day 1

• Triglycerides

  Triglycerides levels (mg/dL) will be will be assessed with a blood chemistry analyzer (Spin120, Spinreact, ESP). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes under fasting conditions (4-6 mL; 2500 rpm for 10 minutes).

  Day 1

• High-density lipoproteins

  High-density lipoproteins concentration (mg/dL) will be will be assessed with a blood chemistry analyzer (Spin120, Spinreact, ESP). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes under fasting conditions (4-6 mL; 2500 rpm for 10 minutes).

  Day 1

• Insulin-like growth factor 1

  The concentration of Insulin-like growth factor 1 (0.1 - 30 ng/mL) will be will be assessed through an enzyme-linked immunosorbent assays (ELISA) on a microplate reader (iMark, BIORAD, USA). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes (4-6 mL; 2500 rpm for 10 minutes).

  Day 1

• Vascular endothelial growth factor

  The concentration of vascular endothelial growth factor (31.3 - 2,000 pg/mL) will be will be assessed through an enzyme-linked immunosorbent assays (ELISA) on a microplate reader (iMark, BIORAD, USA). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes (4-6 mL; 2500 rpm for 10 minutes).

  Day 1

• Estradiol

  The concentration of Estradiol (10 pg/ml - 4300 pg/mL) in young women will be will be assessed through an enzyme-linked immunosorbent assays (ELISA) on a microplate reader (iMark, BIORAD, USA). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes (4-6 mL; 2500 rpm for 10 minutes). Current stage of the menstrual cycle and contraceptive use will be recorded for a proper interpretation of Estradiol levels.

  Day 1

• Progesterone

  The concentration of Progesterone (0.15 ng/mL - 128 ng/mL) in young women will be will be assessed through an enzyme-linked immunosorbent assays (ELISA) on a microplate reader (iMark, BIORAD, USA). For this, serum samples will be obtained by centrifuging peripheral venous blood samples collected in Vacutainer tubes (4-6 mL; 2500 rpm for 10 minutes). Current stage of the menstrual cycle and contraceptive use will be recorded for a proper interpretation of Estradiol levels.

  Day 1

Secondary Outcomes (7)

• Nutrition

  Responding the food frequency questionnaire will take around 10 minutes and the questionnaire will be applied at the single visit the subjects will be requested to attend the laboratory.

• Self-Reported Physical Activity Level

  Day 1

• Perceived Stress

  Day 1

• Depressive symptoms

  Day 1

• Ruminative thinking

  Day 1

Study Arms (5)

Healthy young adults

This group consists of individuals aged 18-35 with no prior diagnosis of insomnia, sleep disorders, or chronic metabolic conditions. Body composition, cardiorespiratory fitness, lifestyle behaviors, DNA integrity and metabolic flexibility will be examined in all participants.

Other: Exercise; Other: Bioelectrical Impedance; Genetic: Micronucleus Assay; Behavioral: Physical activity and sedentary time; Behavioral: Sleep; Biological: blood sampling; Behavioral: psychometrics; Behavioral: Nutritional Supplement; Genetic: Genotyping

College Students

University students aged 18-35 years, with current affiliation to the Universidad Autonoma de Baja California. Body composition, cardiorespiratory fitness, lifestyle behaviors, DNA integrity and metabolic flexibility will be examined in all participants.

Other: Exercise; Other: Bioelectrical Impedance; Genetic: Micronucleus Assay; Behavioral: Physical activity and sedentary time; Behavioral: Sleep; Behavioral: psychometrics; Behavioral: Nutritional Supplement; Genetic: Genotyping

Athletes

Amateur and professional athletes with 2 years of training and competitive experience. Body composition, cardiorespiratory fitness, lifestyle behaviors, DNA integrity and metabolic flexibility will be examined in all participants.

Other: Exercise; Other: Bioelectrical Impedance; Genetic: Micronucleus Assay; Behavioral: Physical activity and sedentary time; Behavioral: Sleep; Biological: blood sampling; Behavioral: psychometrics; Behavioral: Nutritional Supplement; Genetic: Genotyping

Elders

Older adults (65-75 years) without a medical history of cognitive disorders or mental health issues. Body composition, cardiorespiratory fitness, lifestyle behaviors, DNA integrity and metabolic flexibility will be examined in all participants.

Other: Exercise; Other: Bioelectrical Impedance; Genetic: Micronucleus Assay; Behavioral: Physical activity and sedentary time; Behavioral: Sleep; Biological: blood sampling; Behavioral: psychometrics; Behavioral: Nutritional Supplement; Genetic: Genotyping

Metabolic syndrome

Individuals aged 18-35 with previous diagnosis of metabolic syndrome. Body composition, cardiorespiratory fitness, lifestyle behaviors, DNA integrity and metabolic flexibility will be examined in all participants.

Other: Exercise; Other: Bioelectrical Impedance; Genetic: Micronucleus Assay; Behavioral: Physical activity and sedentary time; Behavioral: Sleep; Biological: blood sampling; Behavioral: psychometrics; Behavioral: Nutritional Supplement; Genetic: Genotyping

Interventions

Exercise OTHER

A cardiopulmonary exercise test in a treadmill will be performed after an overnight fasting. Gas exchange, heart rate, and muscle oxygen saturation levels will be assessed continuously during the entire test. Blood pressure and rate of perceived exertion will be recorded prior the end of each stage whereas blood glucose concentration will be assessed before and after the test. All the hemodynamic parameters will be assessed at rest to standardize the cardio-metabolic condition of the participants prior to exercise testing. Maximal exertion will be requested from all participants except elders, in whom a submaximal test will be applied, following the guidelines provided by the American College of Sports Medicine. From this trial, maximal oxygen uptake, ventilatory thresholds/dynamics, chronotropic and inotropic response, and metabolic flexibility will be examined. A trained exercise physiologist will supervise all the tests and validate the obtained data.

Also known as: Cardiopulmonary Exercise Testing

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Bioelectrical Impedance OTHER

Bioelectrical impedance analysis will be used to estimate body compartments through a mechanism of resistance and reactance (InBody 770, KOR) . The compartments measured include body cell mass, fat mass, extracellular tissue, lean mass, muscle mass, visceral adipose tissue area, phase angle, among others.

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Micronucleus Assay GENETIC

The frequency of micronuclei, nuclear buds, basal cells, binucleated cells, condensed chromatin cells, karyorrhexis, karyolysis, and pyknosis will be determined through microscopic examination of exfoliated oral mucosal cells from each participant.

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Physical activity and sedentary time BEHAVIORAL

Physical activity and sedentary time will be assessed through the Spanish version of the International Questionnaire of Physical activity. In half of the analyzed subjects a wearable device (Fitbit luxe, Fit bit Inc) will be also used to record daily steps, energy expenditure and heart rate patterns.

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Sleep BEHAVIORAL

Insomnia severity index, sleep quality, somnolence and chronotype will be subjectively assessed in all participants, using validated scales such as the Pittsburgh, Epworth and ISI questionnaires. In half of the participants, sleep quality will be tracked by wearing a Fit band luxe device in the wrist.

Also known as: Sleep quality, Sleep disorders

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

blood sampling BIOLOGICAL

The concentrations of glucose, glycated hemoglobin, and lipid profile will be determined through serum analysis using a blood chemistry analyzer (Spin120, Spinreact, ESP). Serum samples will be obtained by centrifuging peripheral venous blood samples (4-6 mL) collected in Vacutainer tubes at 2500 rpm for 10 minutes. From the same serum samples, circulating levels of insulin, ovarian hormones (estradiol and progesterone), insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF) will be assessed using enzyme-linked immunosorbent assays (ELISA) on a microplate reader (iMark, BIORAD, USA), following the specifications provided by each kit manufacturer (Biotechne, USA; AccuBind, GUA). Glucose, insulin and triglyceride values obtained from the blood chemistry analyzer and ELISA assays will be used to calculate the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and the triglyceride-glucose index.

Also known as: Blood chemistry

Athletes; Elders; Healthy young adults; Metabolic syndrome

psychometrics BEHAVIORAL

Perceived stress will be obtained from the Perceived Stress Scale adapted for Mexican population. Additionally, depression and anxiety scores will be obtained from the Becks Depression Inventory, validated in Mexican adults. Ruminative thinking will be assessed through the short version of the Ruminative Responses Scale and substance abuse will be examined through the 10-items Drug Abuse Screening Test. Social media disorder and screen time will be also investigated from the Social Media Disorder Test and a cell-phone screen capture.

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Nutritional Supplement BEHAVIORAL

A semi quantitative food frequency questionnaire will be applied to collect data about macronutrient intake and supplements consumption. Hierarchical consumption of each food groups will be also assessed. Last meal consumed prior to exercise testing will be also recorded in conjunction with fasting time.

Also known as: Macronutrient intake

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Genotyping GENETIC

The P10L polymorphism of the OPN4 gene, previously associated with chronic insomnia and severe daytime sleepiness in the Mexican population will be determined using RFLP-PCR assays. DNA will be extracted from previously collected blood samples (4 ml) using the Master Pure DNA purification kit from Epicentre (Illumina Inc., US).

Athletes; College Students; Elders; Healthy young adults; Metabolic syndrome

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Transgender and intersex people wont be considered for this study given that hormonal therapy could influence many of the metabolic and cardiorespiratory outcomes that will be examined in this study. People identified as heterosexual, bisexual, or gay/lesbian will be considered for participation if they fulfill the criteria settled for each study cohort.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit 60 healthy individuals, 60 athletes, 60 university students, 60 older adults, and 60 individuals with metabolic syndrome, ensuring a 1:1 male-to-female ratio in all groups . Participants will be classified based on the presence or absence of insomnia (cases vs. controls), allowing for comparisons of physiological and molecular indicators related to insomnia.

You may qualify if:

• Healthy Individuals (18-35 years old, men and women)
• Waist circumference: \<90 cm (men), \<80 cm (women)
• Fasting glucose: 70-110 mg/dL
• Blood pressure: \<120/80 mmHg
• Triglycerides: \<150 mg/dL
• HDL-C: \>40 mg/dL (men), \>50 mg/dL (women)
• Physical activity level: 600-1500 MET-min/week
• Athletes (18-35 years old, men and women)
• \*Engaged in structured sports training with a physical activity level \>1500 MET-min/week
• Older Adults (65-75 years old, men and women)
• \*Free of cognitive or mental health disorders. No specific cardiometabolic or body composition criteria due to the study's exploratory nature.
• University Students (18-35 years old, men and women)
• \*No specific cardiometabolic or body composition criteria due to the study's exploratory nature.
• Individuals with Metabolic Syndrome (18-35 years old, men and women)
• Waist circumference: \>90 cm (men), \>80 cm (women)

You may not qualify if:

• Individuals with respiratory diseases or musculoskeletal injuries that prevent exercise, as determined by a clinical history review, a physical activity readiness questionnaire (PART-Q+), and pulmonary function tests (spirometry).
• Individuals with rotating or night-shift work schedules (e.g., emergency personnel, security guards), as circadian rhythm disruptions significantly impact sleep quality
• Women diagnosed with polycystic ovary syndrome (PCOS) or showing high testosterone levels with a history of oligomenorrhea, as these conditions may influence metabolic and hormonal markers. However, women with menstrual irregularities related to premenstrual syndrome (PMS) or dysmenorrhea will not be excluded, given the established link between sleep disorders and menstrual cycle variations

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead
• Universidad de Granada: collaborator
• University of Colorado, Denver: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator

Study Sites (1)

Laboratorio de Fisiologia Aplicada al Ejercicio

Ensenada, Estado de Baja California, 22890, Mexico

RECRUITING

Related Publications (14)

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• Serra Laborde, P. L., Torterolo Pizzuti, C., & Calvo Pesce, M. S. (2023). Calidad y cronotipo del sueño y su relación con la obesidad en población adulta. Revisión bibliográfica narrativa. Enfermería: Cuidados Humanizados, 12(2), e3213. https://doi.org/10.22235/ech.v12i2.3213

  BACKGROUND

• Zada D, Bronshtein I, Lerer-Goldshtein T, Garini Y, Appelbaum L. Sleep increases chromosome dynamics to enable reduction of accumulating DNA damage in single neurons. Nat Commun. 2019 Mar 5;10(1):895. doi: 10.1038/s41467-019-08806-w.

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• Carrillo-Mora, P., Barajas-Martinez, K.G., Sanchez-Vazquez, I., Rangel-Caballero, M.F. (2017). Trastornos del sueño: ¿qué son y cuáles son sus consecuencias? Revista de la Facultad de Medicina de la UNAM, 61(1), 6-20.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Buccal epithelial cells and blood samples

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Metabolic Diseases; Motor Activity

Interventions

Exercise; Exercise Test; Electric Impedance; Micronucleus Tests; Sleep; Blood Specimen Collection; Blood Chemical Analysis; Psychometrics; Dietary Supplements; Eating; Genotype

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Electric Conductivity; Electricity; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Mutagenicity Tests; Genetic Techniques; Nervous System Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Clinical Chemistry Tests; Psychological Tests; Behavioral Disciplines and Activities; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Nutritional Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Genetic Phenomena

Study Officials

• Isaac A Chavez-Guevara, PhD

  Universidad Autonoma de Baja California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Renteria, PhD

CONTACT

+52 646 152 823; irenteria@uabc.edu.mx

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Biological Chemistry

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 11, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: All individual records will be kept for five years following the Official Mexican Standard for the management of clinical records in human research. After this period, physical documents will be shredded and disposed of properly.
• Access Criteria: All participant records will be securely stored in the Laboratory of Applied Exercise Physiology, with physical documents kept under restricted access and digital records stored in a private Google Drive folder. To further protect participant confidentiality, once individual analyses are completed, all identifying information will be removed, and data will be anonymized in an Excel database. Only aces to final datasets will be available to researchers associated to this study after appropiate request via Google Drive. Only verified institutional emails will be accepted.

Locations

ME (1)