Muscle Oxygenation, Type 1 Diabetes, and Glycated Hemoglobin
NCT ID: NCT02051504
Last Updated: 2016-09-13
Study Results
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Basic Information
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COMPLETED
79 participants
OBSERVATIONAL
2010-03-31
2013-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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
Incremental maximal exercise
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.
Muscle biopsy
A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
Combined DLCO-DLNO
Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
Dual energy X-ray absorptiometry
Body composition is measured using dual energy X-ray absorptiometry at rest.
Accelerometry over one week
The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
Questionnaires
Diet questionnaire, quality-of-life questionnaires, physical activity 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
Incremental maximal exercise
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.
Muscle biopsy
A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
Combined DLCO-DLNO
Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
Dual energy X-ray absorptiometry
Body composition is measured using dual energy X-ray absorptiometry at rest.
Accelerometry over one week
The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
Questionnaires
Diet questionnaire, quality-of-life questionnaires, physical activity 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
Incremental maximal exercise
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 Test
The subjects arrive after an overnight fast and have a 75g Glucose Oral Charge.
Muscle biopsy
A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
Combined DLCO-DLNO
Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
Dual energy X-ray absorptiometry
Body composition is measured using dual energy X-ray absorptiometry at rest.
Accelerometry over one week
The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
Questionnaires
Diet questionnaire, quality-of-life questionnaires, physical activity 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
Incremental maximal exercise
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 Test
The subjects arrive after an overnight fast and have a 75g Glucose Oral Charge.
Muscle biopsy
A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
Combined DLCO-DLNO
Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
Dual energy X-ray absorptiometry
Body composition is measured using dual energy X-ray absorptiometry at rest.
Accelerometry over one week
The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
Questionnaires
Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires
Interventions
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Incremental maximal exercise
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 Test
The subjects arrive after an overnight fast and have a 75g Glucose Oral Charge.
Muscle biopsy
A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
Combined DLCO-DLNO
Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
Dual energy X-ray absorptiometry
Body composition is measured using dual energy X-ray absorptiometry at rest.
Accelerometry over one week
The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
Questionnaires
Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires
Eligibility Criteria
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Inclusion Criteria
* Healthy subjects
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Elsa HEYMAN, PHD
Role: STUDY_DIRECTOR
EA4488 'Physical activity, Muscle, Health
Pierre FONTAINE, MD-PHD
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
Locations
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CHRU Lille
Lille, , France
Countries
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References
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Jlali 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.
Lespagnol 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.
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.
Tagougui 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.
Tagougui 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.
Other Identifiers
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2009-A00746-51.
Identifier Type: OTHER
Identifier Source: secondary_id
2009_12
Identifier Type: -
Identifier Source: org_study_id
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