Health TrialsbyHealthPanel

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

ConditionsInsomniaCardiorespiratory FitnessMetabolic Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversidad Autonoma de Baja California

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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).

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

This study does not involve chronic dietary or exercise interventions, nor does it require long-term participant follow-up, so no additional exclusion criteria apply

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Exercise

    Other intervention

    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.

  • Bioelectrical Impedance

    Other intervention

    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.

  • 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.

  • 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.

  • 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.

  • blood sampling

    Biological/Vaccine

    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.

  • 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.

  • 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.

  • 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).

Treatment groups

300 Participants
are divided into 5 treatment groups
Group A: Healthy young adults9 interventions
Group B: College Students8 interventions
Group C: Athletes9 interventions
Group D: Elders9 interventions
Group E: Metabolic syndrome9 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 1
2

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

Time frame
Day 1
3

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

Time frame
Day 1
4

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.

Time frame
Day 1

Secondary outcomes

1

Nutrition

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.

Time frame
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.
2

Self-Reported Physical Activity Level

Physical activity and sedentary time will be assessed through the Spanish version of the International Questionnaire of Physical activity, a 7-item tool that allows the estimation of low, moderate, and vigorous physical activity (Mets/min/week), for representing the physical activity level of each participant.

Time frame
Day 1
3

Perceived Stress

Perceived stress will be obtained from the Perceived Stress Scale, previously adapted and validated for Mexican population. This 14-item scale provides a range score between 0-40 that is interpreted as follows: * \<17 low * 13-33 moderate \*\>33 high

Time frame
Day 1
4

Depressive symptoms

Characteristic attitudes and symptoms of depression will be assessed through the Beck Depression Inventory (BDI-II), a 21-item, self-report rating inventory with a range score between 0-63, with the following cut-offs: * 0-13, minimally depressed * 14-19, mildly depressed * 20-28, moderately depressed * 29-63, severely depressed.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Autonoma de Baja California

Lead sponsor

Universidad de Granada

Collaborator

University of Colorado, Denver

Collaborator

Instituto Nacional de Salud Publica, Mexico

Collaborator

Source ClinicalTrials.gov
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