临床试验/NCT06869486

NCT06869486招募中不适用

Insomnia´s Impact on DNA Stability, Cardio-metabolic Health and Lifestyle Behaviors: a Case-control Study

Universidad Autonoma de Baja California1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2024年10月1日最近更新: 2025年3月11日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 300
试验地点: 1
主要终点: Insomnia severity index

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

Insomnia is a prevalent sleep disorder characterized by difficulty initiating or maintaining sleep despite adequate sleep opportunities and an appropriate sleep environment. It affects 10-50% of the adult population worldwide, with several biological, sociodemographic, and psychological-behavioral factors contributing to its occurrence. Notably, its prevalence is higher in women than in men (risk ratio: 1.58, p<0.01) and increases with age, affecting 30-48% of older adults compared to 12-20% of young adults. Additionally, insomnia is more frequently reported among university students than in the general population (18.5% vs. 7.5%), and 13-70% of elite athletes experience persistent sleep disturbances indicative of insomnia.

Recent research has highlighted the long-term negative impact of insomnia on quality of life, as it induces chronic fatigue and excessive daytime sleepiness, which are strongly associated with reduced work productivity, academic performance, and athletic capabilities. Additionally, insomnia has been linked to an increased risk of cardiovascular and metabolic diseases, with a higher prevalence observed in individuals with obesity, type 2 diabetes, and hypertension.

Some studies have reported an inverse association between multiple indicators of insomnia and cardiorespiratory fitness in individuals without chronic diseases, further reinforcing the connection between insomnia and cardiovascular disease risk. This phenomenon may be driven by dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis and the autonomic nervous system, both of which contribute to increased cardiac contractility and altered neuroendocrine function. Moreover, the observed negative correlation between insomnia and oxygen uptake capacity suggests that insomnia may compromise capillary and mitochondrial density as well as cardiovascular efficiency, which are key determinants of maximal oxygen consumption (VO₂max). Another plausible mechanism underlying this association is reduced heart rate variability (HRV) in individuals with chronic insomnia, likely resulting from elevated norepinephrine and cortisol levels, which are known to heighten sympathetic nervous system activity and impair cardiovascular function.

Beyond its cardiovascular implications, sleep deficiency disrupts metabolic homeostasis, promoting high-calorie food consumption through both hormonal (e.g., increased ghrelin secretion) and neurocognitive mechanisms (e.g., heightened hedonic drive for food intake). Over time, these physiological alterations contribute to body weight gain and insulin resistance, increasing the risk of metabolic disorders such as obesity and type 2 diabetes.

At the molecular level, chronic sleep deprivation has been shown to impair DNA repair cycles, which may contribute to the development of metabolic and cardiovascular diseases. Specifically, fragmentation of DNA strands has been observed following sleep restriction, leading to slower chromosomal dynamics and impaired cellular recovery. Additionally, sleep deprivation has demonstrated genotoxic effects in multiple organs and tissues, increasing oxidative DNA damage.

研究设计

研究类型: Observational
观察模型: Case Control
时间视角: Cross Sectional

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Each population group will meet the following inclusion criteria:
•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)
•Fasting glucose: >110 mg/dL
•Blood pressure: >130/80 mmHg
•Triglycerides: >150 mg/dL
•HDL-C: <40 mg/dL (men), <50 mg/dL (women)
•Physical activity level: <600 MET-min/week

排除标准

•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
•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

研究组 & 干预措施

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.

干预措施: Exercise (Other)

Healthy young adults

干预措施: Bioelectrical Impedance (Other)

Healthy young adults

干预措施: Micronucleus Assay (Genetic)

Healthy young adults

干预措施: Physical activity and sedentary time (Behavioral)

Healthy young adults

干预措施: Sleep (Behavioral)

Healthy young adults

干预措施: blood sampling (Biological)

Healthy young adults

干预措施: psychometrics (Behavioral)

Healthy young adults

干预措施: Nutritional Supplement (Behavioral)

Healthy young adults

干预措施: Genotyping (Genetic)

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.

干预措施: Micronucleus Assay (Genetic)

College Students

干预措施: Exercise (Other)

College Students

干预措施: Bioelectrical Impedance (Other)

College Students

干预措施: Physical activity and sedentary time (Behavioral)

College Students

干预措施: Sleep (Behavioral)

College Students

干预措施: psychometrics (Behavioral)

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.

干预措施: Sleep (Behavioral)

College Students

干预措施: Nutritional Supplement (Behavioral)

College Students

干预措施: Genotyping (Genetic)

Athletes

干预措施: Exercise (Other)

Athletes

干预措施: Bioelectrical Impedance (Other)

Athletes

干预措施: Micronucleus Assay (Genetic)

Athletes

干预措施: Physical activity and sedentary time (Behavioral)

Athletes

干预措施: blood sampling (Biological)

Athletes

干预措施: psychometrics (Behavioral)

Athletes

干预措施: Nutritional Supplement (Behavioral)

Athletes

干预措施: Genotyping (Genetic)

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.

干预措施: Exercise (Other)

Elders

干预措施: Bioelectrical Impedance (Other)

Elders

干预措施: Micronucleus Assay (Genetic)

Elders

干预措施: Physical activity and sedentary time (Behavioral)

Elders

干预措施: Sleep (Behavioral)

Elders

干预措施: blood sampling (Biological)

Elders

干预措施: psychometrics (Behavioral)

Elders

干预措施: Nutritional Supplement (Behavioral)

Elders

干预措施: Genotyping (Genetic)

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.

干预措施: Exercise (Other)

Metabolic syndrome

干预措施: Bioelectrical Impedance (Other)

Metabolic syndrome

干预措施: Micronucleus Assay (Genetic)

Metabolic syndrome

干预措施: Physical activity and sedentary time (Behavioral)

Metabolic syndrome

干预措施: Sleep (Behavioral)

Metabolic syndrome

干预措施: blood sampling (Biological)

Metabolic syndrome

干预措施: psychometrics (Behavioral)

Metabolic syndrome

干预措施: Nutritional Supplement (Behavioral)

Metabolic syndrome

干预措施: Genotyping (Genetic)

结局指标

主要结局

Insomnia severity index

时间窗: Day 1

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)

Daytime sleepiness

时间窗: Day 1

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

Sleep quality Index

时间窗: Day 1

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

Body composition

时间窗: Day 1

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.

Insulin-like growth factor 1

时间窗: Day 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).

Vascular endothelial growth factor

时间窗: Day 1

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).

DNA integrity

时间窗: Day 1

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.

OPN4 Single nucleotide polymorphism

时间窗: Day 1

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).

Cardiorespiratory fitness

时间窗: Day 1

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.

Metabolic flexibility

时间窗: Day 1

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.

Homeostatic Model Assessment of Insulin Resistance

时间窗: Day 1

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

Cholesterol

时间窗: Day 1

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).

Triglycerides

时间窗: Day 1

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).

High-density lipoproteins

时间窗: Day 1

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).

Estradiol

时间窗: Day 1

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.

Progesterone

时间窗: Day 1

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.

次要结局

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)
Substance abuse(Day 1)
Screen time(Day 1)

研究者

发起方

Universidad Autonoma de Baja California

申办方类型

Other

责任方

Principal Investigator

主要研究者

Isaac Armando Chavez Guevara

PhD, Biological Chemistry

Universidad Autonoma de Baja California

研究点 (1)

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