Metabolic SyndromeNCT03227575
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
A study testing Exercise Intervention in people with Metabolic Syndrome and Obesity, run by Plymouth State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Sep 2017to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ≥ 30
- Currently not physically active
- Free of any signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Who cannot join
- Planning to become pregnant
- Any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Draper & Maynard
Plymouth, New Hampshire, 03264
Plymouth State University
Plymouth, New Hampshire, 03264
About this study
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.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Exercise Intervention
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Post-Meal Walking Group | Experimental | 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". Receives: Behavioral: Exercise Intervention |
| Traditional Exercise Group | Experimental | 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". Receives: Behavioral: Exercise Intervention |
| Case Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Determine whether ambulatory blood glucose control responses are improved following 28 days of exercise training (Post Training).
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.
Measured: 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).
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.
Measured: An average of 32 days will separate these two measurements.
Secondary outcomes (1)
Determine whether ambulatory blood pressure profiles are different following an average of 28 day exercise intervention compared to sedentary healthy controls.
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.
Measured: An average of 28 days will separate these two measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start7 Sep 2017
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
Why it stopped: Original PI changed institutions and COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plymouth State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227575
- Sponsor's protocol ID
- 0001
- Status last verified
- Nov 2024
- First submitted
- 28 Jun 2017
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
- ClinicalTrials.gov ID
- NCT03227575
- Acronym / sponsor ID
- 0001
- Conditions
- Metabolic Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Original PI changed institutions and COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Plymouth State UniversityUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-Meal Walking Group | Experimental | Behavioral: Exercise InterventionFollowing 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". |
| Traditional Exercise Group | Experimental | Behavioral: Exercise InterventionThe 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". |
| Case Control Group | No intervention | –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". |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index ≥ 30
- Currently not physically active
- Free of any signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Key exclusion criteria (2 listed)
- Planning to become pregnant
- Any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease, and cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionThe use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome. | Behavioural | Post-Meal Walking Group, Traditional Exercise Group |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Metabolic Syndrome and Obesity, run by Plymouth State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.