Hyperglycemia, PostprandialNCT04298710
Effects of Arm Cycling and Leg Cycling on Postprandial Blood Glucose Levels in Healthy Persons
A study testing Arm Cycling, Leg Cycling and Sitting in people with Hyperglycemia, Postprandial, run by Franklin Pierce University at 1 site in United States.
Trial summary
The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Postprandial
- What is being tested?
- Arm Cycling, Leg Cycling and Sitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 15 Aug 2020
- 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy persons
- Age 18 years or above
Who cannot join
- Cardiovascular diseases
- Pulmonary diseases
- Metabolic diseases
- Other contraindications to exercise
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Pierce University
Rindge, New Hampshire, 03461
About this study
Official title: A Comparison Between the Effects of Different Muscle Groups on Blood Glucose Levels at the Postprandial Status in College Students
The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. The purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.
- Conditions
- Hyperglycemia, Postprandial
- Being tested
- Arm Cycling, Leg Cycling, Sitting
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm CyclingBehavioural
20 minutes of arm cycling exercise at light to moderate intensity.
Leg CyclingBehavioural
20 minutes of leg cycling exercise at light to moderate intensity.
SittingBehavioural
Remain seated for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Arm Cycling | Experimental | Arm cycling on an arm crank ergometer for 20 minutes at light to moderate intensity. 30 minutes before the exercise, participants will consume 60g of carbohydrates mixed with plain water. Receives: Behavioral: Arm Cycling |
| Leg Cycling | Experimental | Leg cycling on a leg cycling ergometer for 20 minutes at light to moderate intensity. 30 minutes before the exercise, participants will consume 60g of carbohydrates mixed with plain water. Receives: Behavioral: Leg Cycling |
| Sitting | Placebo comparator | Participants will remain seated after carbohydrates consumption. Receives: Behavioral: Sitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose levels
Measured: one hour after the carbohydrates intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start9 Mar 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Why it stopped: Research lab not accessible due to the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia, PostprandialStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franklin Pierce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tongyu Ma, Franklin Pierce University
- Investigators
- Tongyu Ma, Ph.D., Principal investigator, Franklin Pierce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298710
- Sponsor's protocol ID
- CD02252020
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2020
- Last updated
- 20 Aug 2020
- 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 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Effects of Different Muscle Groups on Blood Glucose Levels at the Postprandial Status in College Students
- ClinicalTrials.gov ID
- NCT04298710
- Acronym / sponsor ID
- CD02252020
- Conditions
- Hyperglycemia, Postprandial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research lab not accessible due to the pandemic.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Franklin Pierce UniversityUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 6 Mar 2020 (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.
The literature has shown that exercise is effective in decreasing blood glucose levels. However, it remains less clear if there is any difference between muscle groups regarding the glucose-lowering effects of exercise. The purpose of this study is to examine the differences in blood-glucose level changes in response to exercise that involves different muscle groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm Cycling | Experimental | Behavioral: Arm CyclingArm cycling on an arm crank ergometer for 20 minutes at light to moderate intensity. 30 minutes before the exercise, participants will consume 60g of carbohydrates mixed with plain water. |
| Leg Cycling | Experimental | Behavioral: Leg CyclingLeg cycling on a leg cycling ergometer for 20 minutes at light to moderate intensity. 30 minutes before the exercise, participants will consume 60g of carbohydrates mixed with plain water. |
| Sitting | Placebo comparator | Behavioral: SittingParticipants will remain seated after carbohydrates consumption. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Apparently healthy persons
- Age 18 years or above
Key exclusion criteria (4 listed)
- Cardiovascular diseases
- Pulmonary diseases
- Metabolic diseases
- Other contraindications to exercise
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 |
|---|---|---|
| Arm Cycling20 minutes of arm cycling exercise at light to moderate intensity. | Behavioural | Arm Cycling |
| Leg Cycling20 minutes of leg cycling exercise at light to moderate intensity. | Behavioural | Leg Cycling |
| SittingRemain seated for 20 minutes. | Behavioural | Sitting |
Primary outcome
Postprandial glucose levels
Time frame: one hour after the carbohydrates intake
Results and safety
The study was stopped early (reason given: Research lab not accessible due to the pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- 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.
Tongyu Ma, Ph.D. principal investigator
Franklin Pierce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm Cycling, Leg Cycling and Sitting in people with Hyperglycemia, Postprandial, run by Franklin Pierce University at 1 site 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Research lab not accessible due to the pandemic.). Results are not available in the source record.
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?
Postprandial glucose levels (time frame: one hour after the carbohydrates intake). 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 20 Aug 2020.