Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03227575 |
| Other study ID # |
0001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 7, 2017 |
| Est. completion date |
July 1, 2020 |
Study information
| Verified date |
March 2019 |
| Source |
Plymouth State University |
| Contact |
Michael Brian, PhD |
| Phone |
603-535-3108 |
| Email |
msbrian[@]plymouth.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Physical activity is shown to positively reduce the risk of developing both cardiovascular
disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity
cardiorespiratory exercise five days per week. However, studies report that <40% of young
adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to
40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity
exercise have been shown to improve glycemic control in young and middle-aged sedentary
adults, however, long term implementation of such exercise regimens are difficult. Recent
evidence suggests that short bouts (15 minutes) of moderate intensity walking following a
meal, significantly improves glycemic control in older adults with impaired glucose control.
Due to the low burden of walking on participants, moderate intensity post-meal walking might
be a better alternative exercise intervention to improve overall health in a sedentary
population. Therefore, the purpose of this pilot proposal is to determine if 15 minutes of
post-meal walking is an effective intervention to improve glycemic control in sedentary young
adults at risk for developing MetS. Additionally, the study will investigate whether
ambulatory blood pressure profiles in obese young adults are disrupted.
Description:
Sedentary young adults (18-39 years) will be recruited from the community and surrounding
areas of Plymouth, NH. In order to be included in the study sample, participants must meet
the following criteria: a BMI > 26.9, body fat % >19.9% for men, body fat greater than 31.9
for women, and who do not participate in regular physical activity. Participants will be free
of any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease,
and cancer.
Questionnaires The investigators will utilize two questionnaires for the study. Investigators
will use a Health History Questionnaire to assess baseline health information. Investigators
will also use the International Physical Activity Questionnaire to assess current physical
activity status.
Waist Circumference, Height, Body Composition, and Weight Investigators will measure waist
circumference using a Gulick measuring tape. Investigators will collect height using
Stadiometer scale. Weight and body composition will be collected using a Tanita Scale, which
assesses weight and body composition
Blood Pressure Blood pressure will be measured utilizing manometry (blood pressure cuff),
which is traditionally used by clinicians to measure blood pressure.
Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect
daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and
allows for the accurate measurement of daily physical activity, steps per day, and daily
heart rate. These variables and other measurement variables from daily activity, heart rate,
and daily steps will be tracked with the watch.
IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein
either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option
for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who
has been previously trained in phlebotomy and proper IV catheter insertion at the University
of Delaware. The IV catheter is vital for completing successive blood draws during the
testing visit. Professor Sandra Gamble, of the Nursing Department, will assist during data
collections to ensure safe blood collections.
75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral
glucose tolerance tests, which is a test to assess the body's response to glucose.
Blood Sample Processing A OneTouch portable blood glucose monitor will be used to assess
blood glucose from whole blood samples during the study visit. The remaining whole blood will
be centrifuged and the extracted serum will be stored for future insulin analysis. All serum
samples will be stored in a -80 freezer until analysis.
24-hour Blood Pressure Monitoring The investigators will utilize a 24-hour blood pressure
monitor (Oscar 2-SunTech Blood Pressure Monitor, Morrisville, NC, USA) to measure blood
pressure over a 24-hour period. The cuff will be fitted to the participant's arm and will
take blood pressure every 20 minutes during the daytime and every 30 minutes during the night
time. Throughout the 24-hour period, participants will be asked to maintain their normal
daily routines.
Questionnaires (Appendix B) We will utilize two questionnaires for the study. We will use a
Health History Questionnaire to assess baseline health information. We will also use the
International Physical Activity Questionnaire to assess current physical activity status.
Waist Circumference, Height, Body Composition, and Weight We will measure waist circumference
using a Gulick measuring tape. We will collect height using Stadiometer scale. Weight and
body composition will be collected using a Tanita Scale, which assesses weight and body
composition.
24-hour Blood Pressure Monitoring We will utilize a 24-hour blood pressure monitor (Oscar
2-SunTech Blood Pressure Monitor, Morrisville, NC, USA) to measure blood pressure over a
24-hour period. The cuff will be fitted to the participant's arm and will take blood pressure
every 20 minutes during the daytime and every 30 minutes during the night time. Throughout
the 24-hour period, participants will be asked to maintain their normal daily routines.
Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect
daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and
allows for the accurate measurement of daily physical activity, steps per day, and daily
heart rate. These variables and other measurement variables from daily activity, heart rate,
and daily steps will be tracked with the watch.
IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein
either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option
for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who
has been previously trained in phlebotomy and proper IV catheter insertion at the University
of Delaware. The IV catheter is vital for completing successive blood draws during the
testing visit.
75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral
glucose tolerance tests, which is a test to assess the body's response to glucose.
Blood Sample Processing Whole blood will be spun down to separate serum and red blood cells.
The serum will be extracted and stored for future insulin analysis. All serum samples will be
stored in a -80 freezer until analysis.
Insulin Analysis In collaboration with Dr. Heather Doherty, insulin analysis will be
performed on stored serum blood samples using a Human Insulin ELISA kit. Dr. Doherty has
offered to assist and guide Dr. Brian in the proper analysis insulin levels measured from our
study population. The analysis will be completed following the completion of the study.
24-hour Continuous Glucose Monitor (CGM) A subcutaneous (just below the skin) Dexcom G5
Sensor (Dexcom; San Diego, California) will be placed on the abdomen by Dr. Michael Brian.
The sensor measures glucose levels in the body every 5 minutes over a 24-hour period for 7
days. Participants will be trained how use the equipment, which requires a participant to
calibrate the sensor two times daily by measuring their blood glucose through a finger prick.
Protocol All participants will complete an informed consent, and then screened prior to being
enrolled into the study. As part of the initial screening visit, participants will complete a
health history questionnaire, International Physical Activity Questionnaire (to assess
current sedentary status), waist circumference measurement, height & weight measures, body
composition, and resting blood pressure. Participants will then be randomized into two study
groups (Post-Meal Walking Group, Traditional Exercise Group).
Continuous Glucose Monitoring Visit
Prior to the "Baseline Study Visit," participants will come to the Exercise and Sports
Physiology Research Laboratory (Draper & Maynard Building, room 417) for CGM training and
subcutaneous sensor insertion. Participants will receive training on proper care of the CGM
unit, calibration techniques, and proper lancet disposal in a Sharps container. Following CGM
sensor insertion and training, participants will be allowed to leave for 1.5 hours while the
sensor warm-ups and then return to the laboratory for sensor calibration. After sensor
calibration, participants will wear the CGM unit for the next 6 days. The total visit will
take approximately 2.5 hours (including the warm-up period).
Baseline Study Visit
Six days after the CGM insertion, participants will arrive 8 hours fasted to the Exercise and
Sports Physiology Research Laboratory (D&M 417) on the morning of the study visit.
Participants will be asked to complete a three-day diet record. Baseline measurements of
height, weight, waist circumference, blood pressure, heart rate, and body composition will be
made. Following the baseline measurements, Michael Brian (PhD) will insert a catheter into
the arm of the participant, leaving a small flexible tubing in the arm to collect blood
samples throughout the protocol. A baseline blood collection will be performed to assess
fasting insulin levels in the body.
Participants will then complete an oral glucose tolerance test. Participants will consume a
75g glucose drink to measure the participant's glycemic response. The glucose drink simulates
an individual consuming a high sugar load, like a soda. Blood samples will be collected at
30, 60, and 120-minute time points following glucose consumption. Following the completion of
the oral glucose tolerance test, the catheter and CGM will be removed and vitals checked
(blood pressure & heart rate). Participants will then be provided with a 24-hour blood
pressure monitor to wear. The participants will return the blood pressure monitor the
following day.
4-Week Exercise Intervention
Following the "Initial Study Visit," participants will be provided with detailed instructions
for their intervention. Participants will be randomly divided into two groups: Post-Meal
Walking Group and Traditional Exercise Control Group.
Throughout the 4-weeks, participants will be asked to continue their regular diet and daily
levels of physical activity. They will be instructed that changing their diet or physical
activity levels outside of the study can significantly impact the study results.
Post-Meal Walking Group
Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to
walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of
moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as
demonstrated in a previous study (5). A Garmin VivoFit activity monitor will measure their
physical activity across the four-week intervention. The Garmin VivoFit activity monitor must
be returned during the "Follow-up Study Visit".
Traditional Exercise Group
The Traditional Exercise Group will perform aerobic and light resistance training exercise
over the 4-week intervention. A group of trained Exercise and Sports Physiology students will
conduct the aerobic exercise and light resistance training program three times per week (180
minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will
measure their physical activity across the four-week intervention. The Garmin VivoFit
activity monitor must be returned during the "Follow-up Study Visit".
A general exercise prescription will be used to standardized all Traditional Exercise
sessions.
Follow-up Study Visit
Participants will complete all of the measurements performed during the "Initial Study Visit"
and all activity monitors will be collected.
Case Control Study
A case control study will be used to measure ambulatory 24-hour blood pressure monitoring in
healthy sedentary controls. This will help in our attempt to determine whether 24-hour blood
pressure control is disrupted in sedentary obese individuals.
After an initial screening visit, participants will wear an ambulatory blood pressure monitor
for 24 hours, and return it the next day. The participants will be instructed to maintain
their current diet and levels of physical activity for four weeks. Any change in diet and
physical activity level might affect the study results. A Garmin VivoFit activity monitor
will be provided to measure their physical activity over four weeks. At the end of the 4-week
period, participants will have their 24-hour blood pressure measured again. The Garmin
VivoFit activity monitor and 24-hour blood pressure cuff must be returned the day after the
24-hour blood pressure monitoring period.
