Endothelial FunctionNCT03651713
Hyperglycemia, Exercise, and Endothelial Function
A study testing GLU+EX and GLU in people with Endothelial Function and Hyperglycemia, run by University of Iowa at 1 site in United States.
Trial summary
The main purpose of this study is to determine if exercise preserves vascular function during hyperglycemia. All subjects will consume a sugary beverage three times daily for seven days. Subjects will be randomly assigned to either the glucose with (GLU+EX) or without (GLU) structured exercise group. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function, Hyperglycemia
- What is being tested?
- GLU+EX and GLU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 21 Oct 2019
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men 18-35 years of age.
Who cannot join
- Hypertension,
- Hyperlipidemia,
- Smoking,
- Heart disease,
- Chest pain upon exertion,
- Previous heart surgeries or history of arrhythmias,
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- Diabetes,
- Obesity (body mass index ≥30kg/m2),
- Kidney disease,
- Pulmonary disease,
- Autonomic disorders,
- Individuals whom engage in structured exercise (≥30min, ≥2d/wk),
- Current use of medications which influence outcome measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Short-Term Glucose Loading on Vascular Function
The main purpose of this study is to determine if exercise preserves vascular function during hyperglycemia. All subjects will consume a sugary beverage three times daily for seven days. Subjects will be randomly assigned to either the glucose with (GLU+EX) or without (GLU) structured exercise group.
Read the detailed description
Acute (oral glucose tolerance test) and chronic (type 2 diabetes) hyperglycemia are associated with impaired endothelial function. Both a single bout of exercise and chronic exercise training are associated with improvements in vascular endothelial function. It remains unknown if exercise can preserve vascular endothelial function during hyperglycemia.
- Conditions
- Endothelial Function, Hyperglycemia
- Being tested
- GLU+EX, GLU
- Keywords
- exercise, glucose, vascular function
- Medical subject headings
- Hyperglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLU+EXBehavioural
Subjects will complete 45 minutes of recumbent cycling at 60-65% of age-predicted maximal heart rate five times over seven days while ingesting a 75g glucose beverage three times daily.
GLUDietary supplement
Subjects will consume a 75g glucose beverage three times daily over a seven-day period.
| Study group | Role | What they receive |
|---|---|---|
| GLU+EX | Experimental | Subjects will consume a 75g glucose beverage three times daily for seven days while participating in five structured aerobic exercise sessions throughout the experimental protocol. Receives: Behavioral: GLU+EX |
| GLU | Active comparator | Subjects will consume a 75g glucose beverage three times daily for seven days without participating in structured aerobic exercise. Receives: Dietary Supplement: GLU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vascular Endothelial Function
Brachial artery flow-mediated dilation (%), measured via Doppler ultrasound, will be assessed before and after the intervention.
Measured: Before and after the seven-day intervention in both groups.
Secondary outcomes (1)
Central Blood Pressure
Aortic blood pressure will be derived from radial artery pressure wave measurements (via applanation tonometry) during resting conditions.
Measured: Before and after the seven-day intervention in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Oct 2018
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial FunctionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren P Casey, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651713
- Sponsor's protocol ID
- 201807752
- Status last verified
- Mar 2020
- First submitted
- 22 Aug 2018
- Last updated
- 24 Mar 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-Term Glucose Loading on Vascular Function
- ClinicalTrials.gov ID
- NCT03651713
- Acronym / sponsor ID
- 201807752
- Conditions
- Endothelial Function, Hyperglycemia
- Keywords
- exercise, glucose, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 29 Aug 2018 (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 main purpose of this study is to determine if exercise preserves vascular function during hyperglycemia. All subjects will consume a sugary beverage three times daily for seven days. Subjects will be randomly assigned to either the glucose with (GLU+EX) or without (GLU) structured exercise group.
Detailed description
Acute (oral glucose tolerance test) and chronic (type 2 diabetes) hyperglycemia are associated with impaired endothelial function. Both a single bout of exercise and chronic exercise training are associated with improvements in vascular endothelial function. It remains unknown if exercise can preserve vascular endothelial function during hyperglycemia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| GLU+EX | Experimental | Behavioral: GLU+EXSubjects will consume a 75g glucose beverage three times daily for seven days while participating in five structured aerobic exercise sessions throughout the experimental protocol. |
| GLU | Active comparator | Dietary Supplement: GLUSubjects will consume a 75g glucose beverage three times daily for seven days without participating in structured aerobic exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy young men 18-35 years of age.
Key exclusion criteria (13 listed)
- Hypertension,
- Hyperlipidemia,
- Smoking,
- Heart disease,
- Chest pain upon exertion,
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 |
|---|---|---|
| GLU+EXSubjects will complete 45 minutes of recumbent cycling at 60-65% of age-predicted maximal heart rate five times over seven days while ingesting a 75g glucose beverage three times daily. | Behavioural | GLU+EX |
| GLUSubjects will consume a 75g glucose beverage three times daily over a seven-day period. | Dietary supplement | GLU |
Primary outcome
Change in Vascular Endothelial Function
Time frame: Before and after the seven-day intervention in both groups.
Brachial artery flow-mediated dilation (%), measured via Doppler ultrasound, will be assessed before and after the intervention.
1 secondary outcome
Central Blood Pressure
Time frame: Before and after the seven-day intervention in both groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLU+EX and GLU in people with Endothelial Function and Hyperglycemia, run by University of Iowa 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 1 inclusion and 13 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: finished, as of the sponsor's last update on 24 Mar 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Vascular Endothelial Function (time frame: Before and after the seven-day intervention in both groups.). 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 24 Mar 2020.