Sleep, Exercise and Insulin Sensitivity
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 40 |
| Updated: | 10/17/2018 |
| Start Date: | October 2018 |
| End Date: | December 2019 |
| Contact: | Jay Porter, MS |
| Email: | jwpp64@mail.missouri.edu |
| Phone: | 7402857685 |
Insufficient or disrupted sleep, lack of physical activity and poor diet are linked with
obesity and are now potential targets to combat obesity. Sleep related issues have become
more important as people have been able to work, socialize, and use electronic devices
outside of daylight hours. This has also altered how we eat and how we exercise. All of these
factors can cause the body to not handle glucose (sugar) well resulting in insulin
resistance. In time this could lead to type 2 diabetes.
obesity and are now potential targets to combat obesity. Sleep related issues have become
more important as people have been able to work, socialize, and use electronic devices
outside of daylight hours. This has also altered how we eat and how we exercise. All of these
factors can cause the body to not handle glucose (sugar) well resulting in insulin
resistance. In time this could lead to type 2 diabetes.
Experimental Design: Subjects will have preliminary screening tests. Two conditions
(with/without exercise) will be completed in a randomized, crossover design. Subjects will
wear an activity monitor (actigraph) and sleep monitor (actiwatch) for 14 days. For the first
7 days this is the lead in period for us to get baseline sleep day. For the following 5 days
they will be asked to reduce their sleep with a specified bed time (ie. 11 pm - 5 am)
followed by 2 days of ad libitum sleep hours, totaling 14 days for each condition. On one
condition we will let them do their usual physical active and on the other condition during
the shortened sleep they will be asked to exercise for 45 min each day at a moderate
intensity (65% VO2max). Meal tests will be assessed after 7 days of normal habits, after 5
days of sleep deprivation, and after 2 days of ad libitum sleep, totaling 6 meal tolerance
tests throughout the entirety of the study. Testing will be conducted at the MU Physical
Activity and Wellness (MUPAW) center in Gwynn Hall and in McKee Gymnasium. Sleep logs will be
done for 3 days prior to the meal test days and food diaries will be done 4 days prior.
Visit 1: Subjects will be provided a verbal explanation of the study and will sign the
informed consent if interested. They will then complete questionnaires assessing health
history, sleep, and physical activity habits. A DXA scan and anthropometrics will also be
recorded. Participants will also perform a maximal peak oxygen consumption test (VO2max) on a
treadmill for calculations during exercise regimen, 65% VO2max. A resting blood pressure will
be measured three times with a sphygmomanometer. A mask will be securely fitted to the
subject's face, covering the nose and mouth, and connected to the Parvo Medics TrueOne 2400
(Parvo Medics, Sandy, UT) metabolic cart via a flexible hose to monitor carbon dioxide
expulsion and oxygen consumption. Heart rate will be monitored through a polar heart rate
monitor chest strap (Polar Elctro, Kempele, Finland). Subjects will be sent home with a pulse
oximeter to sleep with to ensure the subjects do not have sleep apnea.
Visit 2: Subjects will collect physical activity monitor (actigraph) and sleep monitor
(actiwatch) along with surveys to fill out each day about dietary consumption, sleep habits
and physical activity, lasting for 14 days.
Visit 3-5: Subjects will have their resting energy expenditure (REE) measured and then do a
meal test. Subjects will arrive at MUPAW at ~7 am, following at least a 10 hour fast, abstain
from caffeine for >10 hours and alcohol for 24 hours prior to arriving.
REE: A ParvoMedics TrueOne2400 metabolic measurement system (Sandy Lake, UT) will be used to
measure REE. The REE measurement will occur in the morning after an overnight fast and after
ingestion of the meal during testing. During the REE, participants will lay supine in a
recliner for 30 min while all expired air is collected in a canopy that will be placed over
the participants head and analyzed for O2 and CO2 content. The participants will be able to
breath room air normally during the procedure. Expired air will be collected and the O2 and
CO2 values in the expired air will be converted to a REE estimate using the ParvoMedics
software.
Meal test: An IV catheter will be placed in a forearm vein (usually the antecubital vein). A
mixed meal tolerance test will consist of a commercially available shake (16 ounces) that
will be consumed within 10 minutes. Blood samples (~5 mL) will be collected over a 3 hour
period from the start of the test meal ingestion.
Visit 6: Repeat of Visit 2.
Visit 7-9: Repeat of Visit 3-5. Exercise Sessions will be at McKee Gymnasium which will last
45 minutes for 5 days. A mask will be used to monitor oxygen consumption for 10 minutes at
the start of the session to ensure appropriate work load.
Subjects will be reminded not to do any distance driving during their 5 days of shortened
sleep.
2. Blinding, including justification for blinding or not blinding the trial. Describe
un-blinding procedures.
Participants will be told at the beginning of the condition if they are going to be in the
exercise condition or just being monitored for physical activity.
(with/without exercise) will be completed in a randomized, crossover design. Subjects will
wear an activity monitor (actigraph) and sleep monitor (actiwatch) for 14 days. For the first
7 days this is the lead in period for us to get baseline sleep day. For the following 5 days
they will be asked to reduce their sleep with a specified bed time (ie. 11 pm - 5 am)
followed by 2 days of ad libitum sleep hours, totaling 14 days for each condition. On one
condition we will let them do their usual physical active and on the other condition during
the shortened sleep they will be asked to exercise for 45 min each day at a moderate
intensity (65% VO2max). Meal tests will be assessed after 7 days of normal habits, after 5
days of sleep deprivation, and after 2 days of ad libitum sleep, totaling 6 meal tolerance
tests throughout the entirety of the study. Testing will be conducted at the MU Physical
Activity and Wellness (MUPAW) center in Gwynn Hall and in McKee Gymnasium. Sleep logs will be
done for 3 days prior to the meal test days and food diaries will be done 4 days prior.
Visit 1: Subjects will be provided a verbal explanation of the study and will sign the
informed consent if interested. They will then complete questionnaires assessing health
history, sleep, and physical activity habits. A DXA scan and anthropometrics will also be
recorded. Participants will also perform a maximal peak oxygen consumption test (VO2max) on a
treadmill for calculations during exercise regimen, 65% VO2max. A resting blood pressure will
be measured three times with a sphygmomanometer. A mask will be securely fitted to the
subject's face, covering the nose and mouth, and connected to the Parvo Medics TrueOne 2400
(Parvo Medics, Sandy, UT) metabolic cart via a flexible hose to monitor carbon dioxide
expulsion and oxygen consumption. Heart rate will be monitored through a polar heart rate
monitor chest strap (Polar Elctro, Kempele, Finland). Subjects will be sent home with a pulse
oximeter to sleep with to ensure the subjects do not have sleep apnea.
Visit 2: Subjects will collect physical activity monitor (actigraph) and sleep monitor
(actiwatch) along with surveys to fill out each day about dietary consumption, sleep habits
and physical activity, lasting for 14 days.
Visit 3-5: Subjects will have their resting energy expenditure (REE) measured and then do a
meal test. Subjects will arrive at MUPAW at ~7 am, following at least a 10 hour fast, abstain
from caffeine for >10 hours and alcohol for 24 hours prior to arriving.
REE: A ParvoMedics TrueOne2400 metabolic measurement system (Sandy Lake, UT) will be used to
measure REE. The REE measurement will occur in the morning after an overnight fast and after
ingestion of the meal during testing. During the REE, participants will lay supine in a
recliner for 30 min while all expired air is collected in a canopy that will be placed over
the participants head and analyzed for O2 and CO2 content. The participants will be able to
breath room air normally during the procedure. Expired air will be collected and the O2 and
CO2 values in the expired air will be converted to a REE estimate using the ParvoMedics
software.
Meal test: An IV catheter will be placed in a forearm vein (usually the antecubital vein). A
mixed meal tolerance test will consist of a commercially available shake (16 ounces) that
will be consumed within 10 minutes. Blood samples (~5 mL) will be collected over a 3 hour
period from the start of the test meal ingestion.
Visit 6: Repeat of Visit 2.
Visit 7-9: Repeat of Visit 3-5. Exercise Sessions will be at McKee Gymnasium which will last
45 minutes for 5 days. A mask will be used to monitor oxygen consumption for 10 minutes at
the start of the session to ensure appropriate work load.
Subjects will be reminded not to do any distance driving during their 5 days of shortened
sleep.
2. Blinding, including justification for blinding or not blinding the trial. Describe
un-blinding procedures.
Participants will be told at the beginning of the condition if they are going to be in the
exercise condition or just being monitored for physical activity.
Inclusion Criteria:
- Overweight and obese men and women
- BMI of 25-35 kg/m2
- normally active (>5000 steps per day)
- normal sleeping habits of 7-9 hours per night
Exclusion Criteria:
- type 2 diabetics
- diagnosed with cardiovascular disease
- hypertensive
- smokers
- pregnant
- taking lipid-lowering medications
- have any recent changes in hormonal birth control
- night shift workers or take regular daytime naps
- on any medications known to impact metabolism, appetite, or sleep
- have any allergies to milk and soy
- sleep apnea or other sleep disorders
- if the 7 days of sleep monitoring prior to sleep restriction period shows inconsistent
sleep hours outside of 7-9 hours per night.
We found this trial at
1
site
Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Jill kanaley, PhD
Phone: 573-882-2519
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
Click here to add this to my saved trials
