Type 1 DiabetesOXYDIABNCT02051504
Muscle Oxygenation, Type 1 Diabetes, and Glycated Hemoglobin
An observational study of Type 1 Diabetes, run by University Hospital, Lille at 1 site in France.
Trial summary
Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels, reflecting poor long term glycaemic control. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Incremental maximal exercise, Oral Glucose Tolerance Test and Muscle biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2013
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The two groups of patients with Type 1 diabetes are recruited from primary care clinics (university hospital of Lille and hospital of Roubaix, France) among patients with Type 1 diabetes for more than 1 year and free from micro and macrovascular complications. Healthy participants are selected from a list (n=250) drawn up from patients' friends and contacts. Each healthy control is chosen to strictly match a patient with type 1 diabetes according to gender, age, physical activity levels, and tobacco status.
Who may be able to join
- Patients with Type 1 diabetes (duration of Type 1 diabetes > 1 year and < 20 years)
- Healthy subjects
Who cannot join
- Maturity onset diabetes of the young, mitochondrial diabetes, Type 2 diabetes
- Macro or microvascular complications of diabetes
- Diabetes (Glycaemia > 11 mmol/L two hours after the OGTT)
- Obesity (Body Mass Index > 30 kg/m2)
- Contra-indication to maximal exercise
- Pregnant or breast-feeding women
- Other chronic disease than diabetes
- Muscle or articular problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Type 1 Diabetes and Glycated Haemoglobin Levels on Oxygen Delivery and Release to Active Muscle During Exercise and on Muscle Oxidation Capacity - Possible Impact on Aerobic Fitness
Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels, reflecting poor long term glycaemic control. To explain this relationship, the indirect effect of chronically high blood glucose levels on cardiovascular complications - and hence on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes. Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and use and hence on aerobic fitness.
Read the detailed description
The current study aims at assessing the impact of Type 1 diabetes and HbA1c on muscle oxygen delivery and on muscle mitochondrial capacity. Our hypothesis is that these both steps of the oxygen cascade might be involved in the aerobic fitness impairment usually observed in poor-controlled patients.
Adults with Type 1 diabetes, aged 18-40 years, without microvascular and macrovascular diabetic complications, will be recruited among patients that regularly attend the unit of diabetology of the University Hospital of Lille and the regional hospital of Roubaix. They will be separated into 2 groups according to their glycaemic control at entrance in the study (HbA1c < 7%, HbA1c > 8%). Subsequently, two healthy control groups (checked by an OGTT) will be selected to strictly match the patients with Type 1 diabetes (age, sex, BMI, number of hours of physical activity per week, tobacco smoking). This is a cross-sectional study including 4 groups.
On their first visit, after the determination of HbA1c, all the subjects will perform at rest a DLCO/DLNO. Then they will realise an incremental exercise test to exhaustion on an electromagnetic cycle ergometer. Non-invasive measures will be performed throughout the exercise test, including gas exchange parameters (and maximal oxygen uptake), muscular and brain oxygenation (Near Infra Red Spectroscopy at vastus lateralis muscle and at prefrontal cortex). A blood sample from an arterialised ear-lobe will be taken at rest and exhaustion to determine O2 haemoglobin saturation, arterial partial pressure in O2 and CO2, haemoglobin concentration, hematocrit, and bicarbonates. Blood, from a catheter in a superficial cubital vein, will also be taken at rest, at a precise time during the exercise and immediately after the exercise to measure potential of hydrogen, bicarbonates, haemoglobin concentration, hematocrit, erythrocyte 2,3-diphosphoglycerate, and other blood markers of metabolic and hormonal adaptations to exercise. The subjects will also fill in questionnaires.
On a second visit, in a fasting state, the subjects will have a muscle biopsy at vastus lateralis using a specific needle (less than 150mg) in order to assess mitochondrial respiration capacity and endocannabinoid system activity. A venous blood sampling will allow analysing other health markers (lipid profile, insulin resistance...).
On another visit, the subjects will have a measure of body composition by Dual energy X-ray Absorptiometry and skinfold thickness.
They will also wear an accelerometer over one week and fill in a diet questionnaire over 3 days.
- Conditions
- Type 1 Diabetes
- Being tested
- Incremental maximal exercise, Oral Glucose Tolerance Test, Muscle biopsy, Combined DLCO-DLNO, Dual energy X-ray absorptiometry
- Keywords
- Type 1 diabetes, Glycated hemoglobin, Muscle Oxygenation, Exercise, Maximal Oxygen uptake, Mitochondrial respiration, Endocannabinoid system, Oxidative stress
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental maximal exerciseBehavioural
The exercise test starts 2-4h after a standardised breakfast. After a 2-min resting period sitting on the cycle ergometer (Excalibur Sport, Lode B.V, Medical Technology, Groningen, Netherlands), the test starts at 30 watts with a 20 watts increment every 2min until exhaustion.
Oral Glucose Tolerance TestDietary supplement
The subjects arrive after an overnight fast and have a 75g Glucose Oral Charge.
Muscle biopsyProcedure or surgery
A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
Combined DLCO-DLNOProcedure or surgery
Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
Dual energy X-ray absorptiometryProcedure or surgery
Body composition is measured using dual energy X-ray absorptiometry at rest.
Accelerometry over one weekProcedure or surgery
The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
QuestionnairesOther
Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes, HbA1c <7% | Patients with Type 1 diabetes and adequate glycemic control: HbA1c <7% at the entrance in the study.
Intervention:
Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry Receives: Behavioral: Incremental maximal exercise; Procedure: Muscle biopsy; Procedure: Combined DLCO-DLNO; Procedure: Dual energy X-ray absorptiometry; Procedure: Accelerometry over one week; Other: Questionnaires | |
| Type 1 diabetes, HbA1c >8% | Patients with Type 1 diabetes and inadequate glycemic control: HbA1c >8% at the entrance in the study.
Intervention:
Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry Receives: Behavioral: Incremental maximal exercise; Procedure: Muscle biopsy; Procedure: Combined DLCO-DLNO; Procedure: Dual energy X-ray absorptiometry; Procedure: Accelerometry over one week; Other: Questionnaires | |
| Healthy controls, Groupe 1 | Healthy controls for patients with Type 1 diabetes and adequate glycemic control matched on age, sex, body composition and physical activity level.
Intervention:
Oral Glucose Tolerance Test Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry Receives: Behavioral: Incremental maximal exercise; Dietary Supplement: Oral Glucose Tolerance Test; Procedure: Muscle biopsy; Procedure: Combined DLCO-DLNO; Procedure: Dual energy X-ray absorptiometry; Procedure: Accelerometry over one week; Other: Questionnaires | |
| Healthy controls, Group 2 | Healthy controls for patients with Type 1 diabetes and inadequate glycemic control matched on age, sex, body composition and physical activity level.
Intervention:
Oral Glucose Tolerance Test Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry Receives: Behavioral: Incremental maximal exercise; Dietary Supplement: Oral Glucose Tolerance Test; Procedure: Muscle biopsy; Procedure: Combined DLCO-DLNO; Procedure: Dual energy X-ray absorptiometry; Procedure: Accelerometry over one week; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake
Incremental maximal exercise with gas exchange measure
Measured: Participants will perform the incremental maximal exercise on visit 1, one week minimum and 8 weeks maximum after their inclusion in the protocol
Secondary outcomes (4)
Arterial oxygen content during maximal exercise
measured in ear-lobe arterialised capillary samples
Measured: Prior to the incremental maximal exercise on visit 1, and immediately after the incremental maximal exercise on visit 1.
Oxyhemoglobin dissociation at active muscle during maximal exercise
Deoxyhemoglobin and total hemoglobin assessed at vastus lateralis by Near Infrared Spectroscopy
Measured: On visit 1, continuously during the incremental maximal exercise
Mitochondrial respiration capacity of vastus lateralis muscle
Vastus lateralis muscle sample is obtained by the percutaneous technique after local anesthesia. The mitochondrial respiration is then studied in situ in saponin-skinned fibers.
Measured: Participants will have a muscle biopsy on visit 2, performed 3 days minimum and 32 weeks maximum after their visit 1.
Prefrontal cortex oxygenation during exercise
Total hemoglobin and oxyhemoglobin are assessed at the left prefrontal cortex using Near-Infrared Spectroscopy.
Measured: On visit 1, continuously during the incremental maximal exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2010
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa HEYMAN, PHD, Study director, EA4488 'Physical activity, Muscle, HealthPierre FONTAINE, MD-PHD, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051504
- Sponsor's protocol ID
- 2009_12
- Other IDs
- 2009-A00746-51.
- Acronym
- OXYDIAB
- Status last verified
- Sep 2016
- First submitted
- 20 Dec 2013
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heyman E, Daussin F, Wieczorek V, Caiazzo R, Matran R, Berthon P, Aucouturier J, Berthoin S, Descatoire A, Leclair E, Marais G, Combes A, Fontaine P, Tagougui S. Muscle Oxygen Supply and Use in Type 1 Diabetes, From Ambient Air to the Mitochondrial Respiratory Chain: Is There a Limiting Step? Diabetes Care. 2020 Jan;43(1):209-218. doi: 10.2337/dc19-1125. Epub 2019 Oct 21.
PubMed 31636081Jlali I, Heyman E, Matran R, Marais G, Descatoire A, Rabasa-Lhoret R, Touil I, Pawlak-Chaouch M, Mucci P, Fontaine P, Baquet G, Tagougui S. Respiratory function in uncomplicated type 1 diabetes: Blunted during exercise even though normal at rest! Diabet Med. 2023 May;40(5):e15036. doi: 10.1111/dme.15036. Epub 2023 Jan 10.
PubMed 36585956Lespagnol E, Tagougui S, Fernandez BO, Zerimech F, Matran R, Maboudou P, Berthoin S, Descat A, Kim I, Pawlak-Chaouch M, Boissiere J, Boulanger E, Feelisch M, Fontaine P, Heyman E. Circulating biomarkers of nitric oxide bioactivity and impaired muscle vasoreactivity to exercise in adults with uncomplicated type 1 diabetes. Diabetologia. 2021 Feb;64(2):325-338. doi: 10.1007/s00125-020-05329-8. Epub 2020 Nov 21.
PubMed 33219433Tagougui S, Fontaine P, Leclair E, Aucouturier J, Matran R, Oussaidene K, Descatoire A, Prieur F, Mucci P, Vambergue A, Baquet G, Heyman E. Regional cerebral hemodynamic response to incremental exercise is blunted in poorly controlled patients with uncomplicated type 1 diabetes. Diabetes Care. 2015 May;38(5):858-67. doi: 10.2337/dc14-1792. Epub 2015 Feb 9.
PubMed 25665816Tagougui S, Leclair E, Fontaine P, Matran R, Marais G, Aucouturier J, Descatoire A, Vambergue A, Oussaidene K, Baquet G, Heyman E. Muscle oxygen supply impairment during exercise in poorly controlled type 1 diabetes. Med Sci Sports Exerc. 2015 Feb;47(2):231-9. doi: 10.1249/MSS.0000000000000424.
PubMed 24983346
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Type 1 Diabetes and Glycated Haemoglobin Levels on Oxygen Delivery and Release to Active Muscle During Exercise and on Muscle Oxidation Capacity - Possible Impact on Aerobic Fitness
- ClinicalTrials.gov ID
- NCT02051504
- Acronym / sponsor ID
- OXYDIAB / 2009_12
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Glycated hemoglobin, Muscle Oxygenation, Exercise, Maximal Oxygen uptake, Mitochondrial respiration, Endocannabinoid system, Oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
Most of the studies concerning aerobic fitness in Type 1 diabetic patients noted a relationship between impaired aerobic fitness and high glycated haemoglobin (HbA1c) levels, reflecting poor long term glycaemic control. To explain this relationship, the indirect effect of chronically high blood glucose levels on cardiovascular complications - and hence on exercise cardiovascular adaptations - are often mentioned. However, one could wonder if HbA1c could also have a direct impact on aerobic fitness patients with Type 1 diabetes. Haemoglobin glycation may increase its O2 affinity, thus limiting the O2 availability at the muscular level and impairing maximal aerobic power. Moreover, chronic hyperglycaemia might have deleterious effect on muscle mitochondrial capacity to use O2. The aim of this study is to assess the effect of Type 1 diabetes and of HbA1c level on muscular oxygen delivery and use and hence on aerobic fitness.
Detailed description
The current study aims at assessing the impact of Type 1 diabetes and HbA1c on muscle oxygen delivery and on muscle mitochondrial capacity. Our hypothesis is that these both steps of the oxygen cascade might be involved in the aerobic fitness impairment usually observed in poor-controlled patients.
Adults with Type 1 diabetes, aged 18-40 years, without microvascular and macrovascular diabetic complications, will be recruited among patients that regularly attend the unit of diabetology of the University Hospital of Lille and the regional hospital of Roubaix. They will be separated into 2 groups according to their glycaemic control at entrance in the study (HbA1c < 7%, HbA1c > 8%). Subsequently, two healthy control groups (checked by an OGTT) will be selected to strictly match the patients with Type 1 diabetes (age, sex, BMI, number of hours of physical activity per week, tobacco smoking). This is a cross-sectional study including 4 groups.
On their first visit, after the determination of HbA1c, all the subjects will perform at rest a DLCO/DLNO. Then they will realise an incremental exercise test to exhaustion on an electromagnetic cycle ergometer. Non-invasive measures will be performed throughout the exercise test, including gas exchange parameters (and maximal oxygen uptake), muscular and brain oxygenation (Near Infra Red Spectroscopy at vastus lateralis muscle and at prefrontal cortex). A blood sample from an arterialised ear-lobe will be taken at rest and exhaustion to determine O2 haemoglobin saturation, arterial partial pressure in O2 and CO2, haemoglobin concentration, hematocrit, and bicarbonates. Blood, from a catheter in a superficial cubital vein, will also be taken at rest, at a precise time during the exercise and immediately after the exercise to measure potential of hydrogen, bicarbonates, haemoglobin concentration, hematocrit, erythrocyte 2,3-diphosphoglycerate, and other blood markers of metabolic and hormonal adaptations to exercise. The subjects will also fill in questionnaires.
On a second visit, in a fasting state, the subjects will have a muscle biopsy at vastus lateralis using a specific needle (less than 150mg) in order to assess mitochondrial respiration capacity and endocannabinoid system activity. A venous blood sampling will allow analysing other health markers (lipid profile, insulin resistance...).
On another visit, the subjects will have a measure of body composition by Dual energy X-ray Absorptiometry and skinfold thickness.
They will also wear an accelerometer over one week and fill in a diet questionnaire over 3 days.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes, HbA1c <7% | – | Behavioral: Incremental maximal exercise, Procedure: Muscle biopsy, Procedure: Combined DLCO-DLNO, Procedure: Dual energy X-ray absorptiometry, Procedure: Accelerometry over one week, Other: QuestionnairesPatients with Type 1 diabetes and adequate glycemic control: HbA1c <7% at the entrance in the study. Intervention: Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry |
| Type 1 diabetes, HbA1c >8% | – | Behavioral: Incremental maximal exercise, Procedure: Muscle biopsy, Procedure: Combined DLCO-DLNO, Procedure: Dual energy X-ray absorptiometry, Procedure: Accelerometry over one week, Other: QuestionnairesPatients with Type 1 diabetes and inadequate glycemic control: HbA1c >8% at the entrance in the study. Intervention: Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry |
| Healthy controls, Groupe 1 | – | Behavioral: Incremental maximal exercise, Dietary Supplement: Oral Glucose Tolerance Test, Procedure: Muscle biopsy, Procedure: Combined DLCO-DLNO, Procedure: Dual energy X-ray absorptiometry, Procedure: Accelerometry over one week, Other: QuestionnairesHealthy controls for patients with Type 1 diabetes and adequate glycemic control matched on age, sex, body composition and physical activity level. Intervention: Oral Glucose Tolerance Test Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry |
| Healthy controls, Group 2 | – | Behavioral: Incremental maximal exercise, Dietary Supplement: Oral Glucose Tolerance Test, Procedure: Muscle biopsy, Procedure: Combined DLCO-DLNO, Procedure: Dual energy X-ray absorptiometry, Procedure: Accelerometry over one week, Other: QuestionnairesHealthy controls for patients with Type 1 diabetes and inadequate glycemic control matched on age, sex, body composition and physical activity level. Intervention: Oral Glucose Tolerance Test Incremental maximal exercise Near-Infra Red-Spectroscopy at vastus lateralis and pre-frontal cortex (during exercise) Gas exchanges (VO2, VCO2) during exercise Combined DLCO/DLNO (at rest) Venous and arterialised blood sampling (rest and exercise) Muscle biopsy at the vastus lateralis (rest) Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires Accelerometry over one week Dual energy X-ray Absorptiometry |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The two groups of patients with Type 1 diabetes are recruited from primary care clinics (university hospital of Lille and hospital of Roubaix, France) among patients with Type 1 diabetes for more than 1 year and free from micro and macrovascular complications. Healthy participants are selected from a list (n=250) drawn up from patients' friends and contacts. Each healthy control is chosen to strictly match a patient with type 1 diabetes according to gender, age, physical activity levels, and tobacco status.
Key inclusion criteria (2 listed)
- Patients with Type 1 diabetes (duration of Type 1 diabetes > 1 year and < 20 years)
- Healthy subjects
Key exclusion criteria (8 listed)
- Maturity onset diabetes of the young, mitochondrial diabetes, Type 2 diabetes
- Macro or microvascular complications of diabetes
- Diabetes (Glycaemia > 11 mmol/L two hours after the OGTT)
- Obesity (Body Mass Index > 30 kg/m2)
- Contra-indication to maximal 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 |
|---|---|---|
| Incremental maximal exerciseThe exercise test starts 2-4h after a standardised breakfast. After a 2-min resting period sitting on the cycle ergometer (Excalibur Sport, Lode B.V, Medical Technology, Groningen, Netherlands), the test starts at 30 watts with a 20 watts increment every 2min until exhaustion. | Behavioural | Healthy controls, Group 2, Healthy controls, Groupe 1, Type 1 diabetes, HbA1c <7%, Type 1 diabetes, HbA1c >8% |
| Oral Glucose Tolerance TestThe subjects arrive after an overnight fast and have a 75g Glucose Oral Charge. | Dietary supplement | Healthy controls, Group 2, Healthy controls, Groupe 1 |
| Muscle biopsyA sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia. | Procedure or surgery | Healthy controls, Group 2, Healthy controls, Groupe 1, Type 1 diabetes, HbA1c <7%, Type 1 diabetes, HbA1c >8% |
| Combined DLCO-DLNOLung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position. | Procedure or surgery | Healthy controls, Group 2, Healthy controls, Groupe 1, Type 1 diabetes, HbA1c <7%, Type 1 diabetes, HbA1c >8% |
| Dual energy X-ray absorptiometryBody composition is measured using dual energy X-ray absorptiometry at rest. | Procedure or surgery | Healthy controls, Group 2, Healthy controls, Groupe 1, Type 1 diabetes, HbA1c <7%, Type 1 diabetes, HbA1c >8% |
| Accelerometry over one weekThe subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level | Procedure or surgery | Healthy controls, Group 2, Healthy controls, Groupe 1, Type 1 diabetes, HbA1c <7%, Type 1 diabetes, HbA1c >8% |
| QuestionnairesDiet questionnaire, quality-of-life questionnaires, physical activity questionnaires | Other | Healthy controls, Group 2, Healthy controls, Groupe 1, Type 1 diabetes, HbA1c <7%, Type 1 diabetes, HbA1c >8% |
Primary outcome
Maximal oxygen uptake
Time frame: Participants will perform the incremental maximal exercise on visit 1, one week minimum and 8 weeks maximum after their inclusion in the protocol
Incremental maximal exercise with gas exchange measure
4 secondary outcomes
Arterial oxygen content during maximal exercise
Time frame: Prior to the incremental maximal exercise on visit 1, and immediately after the incremental maximal exercise on visit 1.
Oxyhemoglobin dissociation at active muscle during maximal exercise
Time frame: On visit 1, continuously during the incremental maximal exercise
Mitochondrial respiration capacity of vastus lateralis muscle
Time frame: Participants will have a muscle biopsy on visit 2, performed 3 days minimum and 32 weeks maximum after their visit 1.
Prefrontal cortex oxygenation during exercise
Time frame: On visit 1, continuously during the incremental maximal exercise
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 14 May 2026.
- Results publication: PubMed 31636081Heyman E, Daussin F, Wieczorek V, Caiazzo R, Matran R, Berthon P, Aucouturier J, Berthoin S, Descatoire A, Leclair E, Marais G, Combes A, Fontaine P, Tagougui S. Muscle Oxygen Supply and Use in Type 1 Diabetes, From Ambient Air to the Mitochondrial Respiratory Chain: Is There a Limiting Step? Diabetes Care. 2020 Jan;43(1):209-218. doi: 10.2337/dc19-1125. Epub 2019 Oct 21.
- Derived from this study: PubMed 36585956Jlali I, Heyman E, Matran R, Marais G, Descatoire A, Rabasa-Lhoret R, Touil I, Pawlak-Chaouch M, Mucci P, Fontaine P, Baquet G, Tagougui S. Respiratory function in uncomplicated type 1 diabetes: Blunted during exercise even though normal at rest! Diabet Med. 2023 May;40(5):e15036. doi: 10.1111/dme.15036. Epub 2023 Jan 10.
- Derived from this study: PubMed 33219433Lespagnol E, Tagougui S, Fernandez BO, Zerimech F, Matran R, Maboudou P, Berthoin S, Descat A, Kim I, Pawlak-Chaouch M, Boissiere J, Boulanger E, Feelisch M, Fontaine P, Heyman E. Circulating biomarkers of nitric oxide bioactivity and impaired muscle vasoreactivity to exercise in adults with uncomplicated type 1 diabetes. Diabetologia. 2021 Feb;64(2):325-338. doi: 10.1007/s00125-020-05329-8. Epub 2020 Nov 21.
- Derived from this study: PubMed 25665816Tagougui S, Fontaine P, Leclair E, Aucouturier J, Matran R, Oussaidene K, Descatoire A, Prieur F, Mucci P, Vambergue A, Baquet G, Heyman E. Regional cerebral hemodynamic response to incremental exercise is blunted in poorly controlled patients with uncomplicated type 1 diabetes. Diabetes Care. 2015 May;38(5):858-67. doi: 10.2337/dc14-1792. Epub 2015 Feb 9.
- Derived from this study: PubMed 24983346Tagougui S, Leclair E, Fontaine P, Matran R, Marais G, Aucouturier J, Descatoire A, Vambergue A, Oussaidene K, Baquet G, Heyman E. Muscle oxygen supply impairment during exercise in poorly controlled type 1 diabetes. Med Sci Sports Exerc. 2015 Feb;47(2):231-9. doi: 10.1249/MSS.0000000000000424.
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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.
Elsa HEYMAN, PHD study director
EA4488 'Physical activity, Muscle, Health
Pierre FONTAINE, MD-PHD principal investigator
CHRU LILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University Hospital, Lille 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 2 inclusion and 8 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 14 May 2026. 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?
Maximal oxygen uptake (time frame: Participants will perform the incremental maximal exercise on visit 1, one week minimum and 8 weeks maximum after their inclusion in the protocol). 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 NCT02051504, which also lists 5 linked publications.
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 14 May 2026.