Capillary Glycerolemia Evolution During Physical Exercise

NCT04084691 | Completed

• 1 other identifier: 190089 - IDRCB 2019-A00200-57
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Physical Activity; Body Mass Index

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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)

  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)

  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)

  60 minutes after the beginning of exercise

Secondary Outcomes (2)

• 1. Maximum concentration of glycerol in capillary blood

  from the beginning of the exercise and during one hour

• 2. Glycerol concentration in peripheral venous blood,

  30 minutes after the beginning of bodybuilding exercise (i.e. at the end of the exercice)

Study Arms (1)

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.

Other: Physical exercice - moderate intensity; Other: Physical exercice - high intensity; Other: Physical exercice - workout; Other: Normal meal; Other: Normalized meal; Other: Fasting

Interventions

Physical exercice - moderate intensity OTHER

standardized physical activity (moderate intensity) lasting 30 minutes and having a warm-up portion of 5 minutes

Single Arm

Physical exercice - high intensity OTHER

standardized physical activity (high intensity) lasting 30 minutes and having a warm-up portion of 5 minutes

Single Arm

Physical exercice - workout OTHER

standardized physical activity (bodybuilding) lasting 30 minutes and having a warm-up portion of 5 minutes

Single Arm

Normal meal OTHER

\- 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.

Single Arm

Normalized meal OTHER

\- 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.

Single Arm

Fasting OTHER

non meal in the hour before exercise

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat Claude-Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Boris HANSEL, MD PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: September 10, 2019
• Study Start: October 23, 2019
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: February 25, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)