Physical ActivityLSEEGLYCEROLNCT04084691
Capillary Glycerolemia Evolution During Physical Exercise
A study testing Physical exercice - moderate intensity, Physical exercice - high intensity and Physical exercice - workout in people with Physical Activity and Body Mass Index, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Maximum fatty acid oxidation is known to occur at exercise intensities between 45 and 65% VO2max and in the fasting state. However, the optimal level may depend on various unknown factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, Body Mass Index
- What is being tested?
- Physical exercice - moderate intensity, Physical exercice - high intensity and Physical exercice - workout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2019to 11 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients followed in Diabetology-Nutrition Day Hospital of Bichat-Claude Bernard Hospital as part of the ETAPES program
- overweight or obese patient: body mass index BMI> 25 kg / m²
- Volunteer to participate in and follow a proposed physical activity program as part of regular follow-up
- Volunteer to participate in the research, comfortable with the use of the device of auto measurement of capillary glycerolemia
Who cannot join
- Pregnancy in progress or breastfeeding
- Patient under guardianship or curatorship
- Patient participating in another interventional research protocol
- No affiliation to the social security scheme or French Universal Health Cover (CMU)
- Absence of informed consent, written and signed
Trial locations and contacts
1 site in 1 country.
About this study
Maximum fatty acid oxidation is known to occur at exercise intensities between 45 and 65% VO2max and in the fasting state.
However, the optimal level may depend on various unknown factors. Glycerolemia is a good marker of the fatty acid metabolism but its evolution remains poorly described, maybe due to the difficulty of the measure.
Read more
A new device allows an easy measurement of glycerolemia during exercise and could enable personalization strategies to optimize exercise efficacy.
In this study, the investigators plan to test three different exercise types and three different fasting conditions with three replicates each to evaluate the variability of glycerolemia and its evolution during exercise.
Read the detailed description
The metabolism of mobilized fatty acids as an energy reserve during physical exercise produces glycerol, which makes it a marker of the intensity of lipolysis.
This measurement of the intensity of lipolysis in humans can be carried out according to several methods. Since glycerol is a product of lipolysis, its rate of appearance (Ra) in the blood represents a physical quantity naturally associated with lipolysis activity. Unfortunately, its quantification requires the use of a tracer isotope (deuterated glycerol), which limits its applicability. The alternative is the determination of glycerolemia in the blood or in the interstitial fluid via a microdialysis probe placed in subcutaneous adipose tissue;
Recently, a measuring device has been proposed which makes it possible to measure glycerolemia from capillary blood, in the manner of measuring blood glucose in diabetic patients. This device has the advantage of being used repeatedly after a physical exercise. This flexibility also makes it possible to consider the personalization of the sports program by identifying the circumstances associated with an increase in lipolysis such as the type of meal preceding the exercise or its intensity.
Evidence suggests that moderate-intensity exercise (about 45% -65% VO2max) performed under fasting conditions maximizes lipid metabolism as a source of energy, compared with carbohydrate metabolism. But these data conceal a likely significant variability in individual outcomes, including levels of training, gender, age, and nutritional intake prior to exercise. Our hypothesis is that the current recommendation to the diabetic patient, or with a metabolic syndrome, to exercise moderate intensity fasting physical activity could be adapted individually to each patient in order to optimize the benefits of such a practice. In this sense, the easy access to a measurement of capillary glycerolemia could make it possible to identify in a personalized way the type of physical activity.
This research project aims to accurately describe the evolution of capillary glycerolemia in several configurations of physical exercise (variable intensity) by controlling the effect of the previous meal. It will also seek to identify situations associated with a greater increase in capillary glycerolemia to pave the way for personalization of the sports activity program.
- Conditions
- Physical Activity, Body Mass Index
- Being tested
- Physical exercice - moderate intensity, Physical exercice - high intensity, Physical exercice - workout, Normal meal, Normalized meal
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercice - moderate intensityOther
standardized physical activity (moderate intensity) lasting 30 minutes and having a warm-up portion of 5 minutes
Physical exercice - high intensityOther
standardized physical activity (high intensity) lasting 30 minutes and having a warm-up portion of 5 minutes
Physical exercice - workoutOther
standardized physical activity (bodybuilding) lasting 30 minutes and having a warm-up portion of 5 minutes
Normal mealOther
- Hyperlipidic meal Energy supply: 800 kcal Distribution of macronutrients: proteins: 15% +/- 5; carbohydrates: 40% +/- 5; lipids: 45 +/- 5 Choice of foods determined with the dietician taking into account the patient's tastes and products available on the market The same meal will be taken before the 3 sessions concerned.
Normalized mealOther
- Hyperglucidic meal Energy supply: 800 kcal Macronutrient distribution: protein 15% +/- 5; carbohydrates 60% +/- 5; lipids 25 +/- 2 Choice of foods determined with the dietician taking into account the patient's tastes and products available on the market.
The same meal will be taken before the 3 sessions concerned.
FastingOther
non meal in the hour before exercise
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Every patient will undergo every combination of physical exercise/meal type (3x3 combinations), one following the other. Each combination is replicated three times. Receives: Other: Physical exercice - moderate intensity; Other: Physical exercice - high intensity; Other: Physical exercice - workout; Other: Normal meal; Other: Normalized meal; Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of glycerol in capillary blood
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
Measured: at the beginning of exercise
concentration of glycerol in capillary blood
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
Measured: 20 minutes after the beginning of exercise
concentration of glycerol in capillary blood
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
Measured: 30 minutes after the beginning of exercise
concentration of glycerol in capillary blood
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
Measured: 45 minutes after the beginning of exercise
concentration of glycerol in capillary blood
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
Measured: 60 minutes after the beginning of exercise
Secondary outcomes (2)
1. Maximum concentration of glycerol in capillary blood
Maximum capillary glycerolemia (peak) among the time series
Measured: from the beginning of the exercise and during one hour
2. Glycerol concentration in peripheral venous blood,
Glycerolemia in peripheral venous blood, measured at the end of a bodybuilding type exercise session
Measured: 30 minutes after the beginning of bodybuilding exercise (i.e. at the end of the exercice)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start23 Oct 2019
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris HANSEL, MD PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084691
- Sponsor's protocol ID
- 190089 - IDRCB 2019-A00200-57
- Acronym
- LSEEGLYCEROL
- Status last verified
- Nov 2020
- First submitted
- 1 Aug 2019
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Glycerolemia Evolution During Physical Exercise
- ClinicalTrials.gov ID
- NCT04084691
- Acronym / sponsor ID
- LSEEGLYCEROL / 190089 - IDRCB 2019-A00200-57
- Conditions
- Physical Activity, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 10 Sep 2019 (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.
Maximum fatty acid oxidation is known to occur at exercise intensities between 45 and 65% VO2max and in the fasting state.
However, the optimal level may depend on various unknown factors. Glycerolemia is a good marker of the fatty acid metabolism but its evolution remains poorly described, maybe due to the difficulty of the measure.
A new device allows an easy measurement of glycerolemia during exercise and could enable personalization strategies to optimize exercise efficacy.
In this study, the investigators plan to test three different exercise types and three different fasting conditions with three replicates each to evaluate the variability of glycerolemia and its evolution during exercise.
Detailed description
The metabolism of mobilized fatty acids as an energy reserve during physical exercise produces glycerol, which makes it a marker of the intensity of lipolysis.
This measurement of the intensity of lipolysis in humans can be carried out according to several methods. Since glycerol is a product of lipolysis, its rate of appearance (Ra) in the blood represents a physical quantity naturally associated with lipolysis activity. Unfortunately, its quantification requires the use of a tracer isotope (deuterated glycerol), which limits its applicability. The alternative is the determination of glycerolemia in the blood or in the interstitial fluid via a microdialysis probe placed in subcutaneous adipose tissue;
Recently, a measuring device has been proposed which makes it possible to measure glycerolemia from capillary blood, in the manner of measuring blood glucose in diabetic patients. This device has the advantage of being used repeatedly after a physical exercise. This flexibility also makes it possible to consider the personalization of the sports program by identifying the circumstances associated with an increase in lipolysis such as the type of meal preceding the exercise or its intensity.
Evidence suggests that moderate-intensity exercise (about 45% -65% VO2max) performed under fasting conditions maximizes lipid metabolism as a source of energy, compared with carbohydrate metabolism. But these data conceal a likely significant variability in individual outcomes, including levels of training, gender, age, and nutritional intake prior to exercise. Our hypothesis is that the current recommendation to the diabetic patient, or with a metabolic syndrome, to exercise moderate intensity fasting physical activity could be adapted individually to each patient in order to optimize the benefits of such a practice. In this sense, the easy access to a measurement of capillary glycerolemia could make it possible to identify in a personalized way the type of physical activity.
This research project aims to accurately describe the evolution of capillary glycerolemia in several configurations of physical exercise (variable intensity) by controlling the effect of the previous meal. It will also seek to identify situations associated with a greater increase in capillary glycerolemia to pave the way for personalization of the sports activity program.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: Physical exercice - moderate intensity, Other: Physical exercice - high intensity, Other: Physical exercice - workout, Other: Normal meal, Other: Normalized meal, Other: FastingEvery patient will undergo every combination of physical exercise/meal type (3x3 combinations), one following the other. Each combination is replicated three times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patients followed in Diabetology-Nutrition Day Hospital of Bichat-Claude Bernard Hospital as part of the ETAPES program
- overweight or obese patient: body mass index BMI> 25 kg / m²
- Volunteer to participate in and follow a proposed physical activity program as part of regular follow-up
- Volunteer to participate in the research, comfortable with the use of the device of auto measurement of capillary glycerolemia
Key exclusion criteria (5 listed)
- Pregnancy in progress or breastfeeding
- Patient under guardianship or curatorship
- Patient participating in another interventional research protocol
- No affiliation to the social security scheme or French Universal Health Cover (CMU)
- Absence of informed consent, written and signed
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 |
|---|---|---|
| Physical exercice - moderate intensitystandardized physical activity (moderate intensity) lasting 30 minutes and having a warm-up portion of 5 minutes | Other | Single Arm |
| Physical exercice - high intensitystandardized physical activity (high intensity) lasting 30 minutes and having a warm-up portion of 5 minutes | Other | Single Arm |
| Physical exercice - workoutstandardized physical activity (bodybuilding) lasting 30 minutes and having a warm-up portion of 5 minutes | Other | Single Arm |
| Normal meal- Hyperlipidic meal Energy supply: 800 kcal Distribution of macronutrients: proteins: 15% +/- 5; carbohydrates: 40% +/- 5; lipids: 45 +/- 5 Choice of foods determined with the dietician taking into account the patient's tastes and products available on the market The same meal will be taken before the 3 sessions concerned. | Other | Single Arm |
| Normalized meal- Hyperglucidic meal Energy supply: 800 kcal Macronutrient distribution: protein 15% +/- 5; carbohydrates 60% +/- 5; lipids 25 +/- 2 Choice of foods determined with the dietician taking into account the patient's tastes and products available on the market. The same meal will be taken before the 3 sessions concerned. | Other | Single Arm |
| Fastingnon meal in the hour before exercise | Other | Single Arm |
Primary outcome
concentration of glycerol in capillary blood
Time frame: at the beginning of exercise
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
concentration of glycerol in capillary blood
Time frame: 20 minutes after the beginning of exercise
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
concentration of glycerol in capillary blood
Time frame: 30 minutes after the beginning of exercise
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
concentration of glycerol in capillary blood
Time frame: 45 minutes after the beginning of exercise
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
concentration of glycerol in capillary blood
Time frame: 60 minutes after the beginning of exercise
The primary endpoint is the time series of measurements of capillary glycerol concentration using the DietSee device (LSEE, Ajaccio, France)
2 secondary outcomes
1. Maximum concentration of glycerol in capillary blood
Time frame: from the beginning of the exercise and during one hour
2. Glycerol concentration in peripheral venous blood,
Time frame: 30 minutes after the beginning of bodybuilding exercise (i.e. at the end of the exercice)
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 25 Feb 2021.
- 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.
Boris HANSEL, MD PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercice - moderate intensity, Physical exercice - high intensity and Physical exercice - workout in people with Physical Activity and Body Mass Index, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 5 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 25 Feb 2021. 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 France. 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?
concentration of glycerol in capillary blood (time frame: at the beginning of exercise). The study lists 5 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 25 Feb 2021.