Glucose, High BloodGLYEXERNCT04846751
Exercise Type That Faster Reduces Postprandial Glycemia.
A study testing TYPE OF EXERCISE (OR REST) in people with Glucose, High Blood and Exercise-Induced Hyperinsulinism, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, High Blood, Exercise-Induced Hyperinsulinism
- What is being tested?
- TYPE OF EXERCISE (OR REST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 10 Sep 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be capable and willing to provide consent, understand, instructions and protocols.
- Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.
Who cannot join
- Smokers
- Pregnancy
- Any non-controlled medical condition which could influence results or could be worsened by exercise
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Castilla-La Mancha (Exercise Physiology Lab)
Toledo, 45071
About this study
It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. The purpose of this study is to elucidate if intervalic exercise is superior to continous on improving postprandial glycemic control.
Read the detailed description
Carbohydrate oxidation, glucose and insulin blood concentrations, isotopically measured rate of appearance of endogenous and exogenous glucose will be measured in 4 ocassions.
Participants will undergo in a cross-over randomized fashion the following trials:
- Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
- Exercise pedalling during 50 min in a hot environment (33ºC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
- Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT).
- No exercise, followed by an oral glucose tolerance test (OGTT).
- Being tested
- TYPE OF EXERCISE (OR REST)
- Medical subject headings
- Hyperinsulinemic hypoglycemia, familial, 7
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TYPE OF EXERCISE (OR REST)Behavioural
continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.
| Study group | Role | What they receive |
|---|---|---|
| AEROBIC EXERCISE | Active comparator | 50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max Receives: Behavioral: TYPE OF EXERCISE (OR REST) |
| PLACEBO REST | Placebo comparator | No exercise, resting during 50 min. Receives: Behavioral: TYPE OF EXERCISE (OR REST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentration
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Measured: 16 weeks
Blood insulin concentration
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Measured: 16 weeks
Secondary outcomes (2)
Carbohydrate oxidation
Measured using indirect calorimetry
Measured: 16 weeks
Turnover rate of endogenous and exogenous glucose
Measured using isotopic tracers.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Nov 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose, High BloodStudies 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
- Crossover
- Model description
- Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Mora, University of Castilla-La Mancha
- Investigators
- Ricardo Mora-Rodriguez, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846751
- Sponsor's protocol ID
- PID2020-116159RB-I00
- Acronym
- GLYEXER
- Status last verified
- Nov 2022
- First submitted
- 11 Apr 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request.
Publications
Mora-Rodriguez R, Moreno-Cabanas A, Alvarez-Jimenez L, Mora-Gonzalez D, Morales-Palomo F. High-Intensity Intervallic Exercise (HIIE) Is Superior to Isocaloric Moderate-Intensity Continuous Exercise (MICE) at Reducing Postprandial Hyperglycemia. Med Sci Sports Exerc. 2025 May 1;57(5):1019-1031. doi: 10.1249/MSS.0000000000003625. Epub 2024 Dec 10.
PubMed 39661748
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Type That Faster Reduces Postprandial Glycemia.
- ClinicalTrials.gov ID
- NCT04846751
- Acronym / sponsor ID
- GLYEXER / PID2020-116159RB-I00
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 15 Apr 2021 (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.
It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout. However, it is less well known, what is the exercise type more efficient to buffer the elevations in blood glucose elicited by carbohydrate ingestion. The purpose of this study is to elucidate if intervalic exercise is superior to continous on improving postprandial glycemic control.
Detailed description
Carbohydrate oxidation, glucose and insulin blood concentrations, isotopically measured rate of appearance of endogenous and exogenous glucose will be measured in 4 ocassions.
Participants will undergo in a cross-over randomized fashion the following trials:
- Exercise pedalling during 50 min at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
- Exercise pedalling during 50 min in a hot environment (33ºC) at 60% of their VO2max followed by an oral glucose tolerance test (OGTT).
- Exercise pedalling during 50 min using intervalic bouts averaging 60% of VO2max followed by an oral glucose tolerance test (OGTT).
- No exercise, followed by an oral glucose tolerance test (OGTT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study composed of 4 trials, full-crossover, administered in a randomized order with the inclusion of a control trial.
| Arm | Type | Receives |
|---|---|---|
| AEROBIC EXERCISE | Active comparator | Behavioral: TYPE OF EXERCISE (OR REST)50 min of aerobic exercise by pedaling a cycleergometer at 60% of VO2max |
| PLACEBO REST | Placebo comparator | Behavioral: TYPE OF EXERCISE (OR REST)No exercise, resting during 50 min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant must be capable and willing to provide consent, understand, instructions and protocols.
- Minimal fitness level to be able to complete 50 min of continous exercise at a moderate intensity.
Key exclusion criteria (3 listed)
- Smokers
- Pregnancy
- Any non-controlled medical condition which could influence results or could be worsened by 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 |
|---|---|---|
| TYPE OF EXERCISE (OR REST)continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature. | Behavioural | AEROBIC EXERCISE, PLACEBO REST |
Primary outcome
Blood glucose concentration
Time frame: 16 weeks
Incremental area under the curve during the 120 min of the oral glucose tolerance test
Blood insulin concentration
Time frame: 16 weeks
Incremental area under the curve during the 120 min of the oral glucose tolerance test
2 secondary outcomes
Carbohydrate oxidation
Time frame: 16 weeks
Turnover rate of endogenous and exogenous glucose
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 39661748Mora-Rodriguez R, Moreno-Cabanas A, Alvarez-Jimenez L, Mora-Gonzalez D, Morales-Palomo F. High-Intensity Intervallic Exercise (HIIE) Is Superior to Isocaloric Moderate-Intensity Continuous Exercise (MICE) at Reducing Postprandial Hyperglycemia. Med Sci Sports Exerc. 2025 May 1;57(5):1019-1031. doi: 10.1249/MSS.0000000000003625. Epub 2024 Dec 10.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request.
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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.
Ricardo Mora-Rodriguez, PhD principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TYPE OF EXERCISE (OR REST) in people with Glucose, High Blood and Exercise-Induced Hyperinsulinism, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Nov 2022. 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 Spain. 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?
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?
Blood glucose concentration (time frame: 16 weeks). 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?
On the ClinicalTrials.gov record for NCT04846751, which also lists 1 linked publication.
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 4 Nov 2022.