Clinical trial NCT04105218: Exercise, Sleep Quality and Nocturnal Fat Oxidation in Metabolic Syndrome
Official title: The Effect of Exercise on Sleep Quality and Nocturnal Fat Oxidation in Individuals With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolic Syndrome
PreDiabetes
Hypertension
Obesity
Hyperlipidemias
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the Exerci-Zzz Study is to learn more about how the time of day that exercise is performed influences sleep quality and fat metabolism overnight in adults with metabolic syndrome. In this study, exercise will be performed in the early evening and the investigators will measure participants' sleep quality and fat metabolism overnight in a metabolic room. The total study will take approximately 2-3 months to complete.

Enrolled participants will complete 2 study conditions (evening exercise and control) in a metabolic room. Each of these visits will last 30 hours and require that the participant stay in the metabolic room. During the evening exercise participants will be asked to perform exercise in the early evening. Finally, during the control condition participants will be asked spend the day in the metabolic room (no exercise performed during this condition). During each of these conditions, the investigators will measure participant sleep quality and fat metabolism overnight. In the morning, the investigators will perform a metabolic test to assess the responses of certain hormones. Findings from this study will identify how exercise influences novel contributors to metabolic syndrome (sleep quality and nocturnal metabolism) and shed light on some potential mechanisms to explain the variability in exercise responses.

Detailed description: Metabolic syndrome (MetS) is a major risk factor for many chronic diseases, including diabetes and cardiovascular disease. Sleep is recognized a risk factor for many of the conditions comprising MetS (e.g. high blood sugars, obesity). Interestingly, fat metabolism during your sleep is important for regulating several key components of health, like risk of obesity and glucose tolerance. While exercise is recognized as a health enhancing behavior to reduce the risk of many chronic diseases, the effect of exercise on sleep quality and nocturnal fat metabolism is largely unknown. This study plans to learn more about how the time of day that you perform exercise influences sleep quality and fat metabolism overnight in adults with metabolic syndrome. In this study, exercise will be performed in the early evening and the investigators will measure your sleep quality and fat metabolism overnight in our metabolic room. Findings from this study will identify how exercise influences novel contributors to metabolic syndrome (sleep quality and nocturnal metabolism) and shed light on some potential mechanisms to explain the variability in exercise responses.

Eligibility criteria: Inclusion Criteria:

* not currently meeting physical activity guidelines (\<150 minutes moderate to vigorous physical activity per week);
* weight stable (\<5% change in weight over the last 6 months);
* habitual sleep duration of 7-8 hours and consistent sleep/wake schedule (\<1 hour variation night-to-night).

Exclusion Criteria:

* body mass index \>35.0 kg/m2; pregnancy;
* post-menopausal status in women, confirmed by absences of menses for \>1 year and elevated follicular stimulating hormone concentrations (\>50 mIU/mL); women on oral contraceptives;
* self-reported diabetes, cardiovascular disease, or sleep disorder;
* untreated hyper/hypothyroidism, cancer;
* inability to perform moderate to vigorous treadmill exercise;
* shiftwork

Primary outcomes:
measure: Nocturnal FFA Concentrations
timeFrame: 8-hours
Secondary outcomes:
measure: Nocturnal Fat Oxidation
timeFrame: 8-hours
measure: Nocturnal Glucose and Insulin Concentrations
timeFrame: 8-hours
measure: Sleep Quality (Percent Time in Slow Wave Sleep [SWS])
timeFrame: 8-hours
measure: Sleep Latency
timeFrame: 8-hours
measure: Sleep Interruptions
timeFrame: 8-hours
Other outcomes:
measure: Dietary Fat Oxidation
timeFrame: 24-hours
measure: Distal/Proximal Temperature Gradient
timeFrame: 24-hours
measure: Melatonin Offset
timeFrame: First 5 hours of waking (after study condition)
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: jennifer.blankenship@cuanschutz.edu
name: Jennifer Blankenship, PhD
role: PRINCIPAL_INVESTIGATOR
References: