- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227575
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Hampshire
-
Plymouth, New Hampshire, United States, 03264
- Recruiting
- Draper & Maynard
-
Contact:
- Michael S Brian, PhD
- Phone Number: 603-535-3108
- Email: msbrian@plymouth.edu
-
Plymouth, New Hampshire, United States, 03264
- Not yet recruiting
- Plymouth State University
-
Contact:
- Andrew Ines
- Phone Number: 603-535-3233
- Email: agines@plymouth.edu
-
Principal Investigator:
- Michael Brian, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index ≥ 30
- Currently not physically active
- Free of any signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Exclusion Criteria:
- Planning to become pregnant
- Any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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".
|
The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.
|
Experimental: 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".
|
The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.
|
No Intervention: Case Control Group
The participant will be instructed to maintain their current diet and levels of physical activity for four weeks.
Participants in this group will wear an ambulatory blood pressure monitor at baseline and at follow-up.
Any change in diet and physical activity level might significantly affect the study results.
The Control Group will maintain their current lifestyle for four weeks.
Garmin VivoFit activity monitors will measure their physical activity throughout the 4-week intervention.
The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine whether ambulatory blood glucose control responses are improved following 28 days of exercise training (Post Training).
Time Frame: An average of 32 days will separate these two measurements.
|
Examine blood glucose (mg/dL) responses during two oral glucose tolerance test (70g glucose drink).
The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training.
These two tests (Base vs Post Training) will be separated by an average of 32 days.
|
An average of 32 days will separate these two measurements.
|
Determine whether serum insulin (IU/mL) responses are improved following 28 days of exercise training (Post Training).
Time Frame: An average of 32 days will separate these two measurements.
|
Examine serum insulin (IU/mL) responses during two oral glucose tolerance tests (70g glucose drink).
The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training.
These two tests (Base vs Post Training) will be separated by an average of 32 days.
|
An average of 32 days will separate these two measurements.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine whether ambulatory blood pressure profiles are different following an average of 28 day exercise intervention compared to sedentary healthy controls.
Time Frame: An average of 28 days will separate these two measurements.
|
We will exam ambulatory 24-hour blood pressure profiles in healthy sedentary young adults at baseline, and then re-measure ambulatory 24-hour blood pressure profiles during a follow-up visit.
These will be compared to our obese young adults.
|
An average of 28 days will separate these two measurements.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Cancer Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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