Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Pancreatic Neoplasms

Chronic Disease

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Wasting Syndrome

Cachexia

Syndrome

Respiratory Tract Diseases

Disease Attributes

Lung Diseases, Obstructive

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Chronic Graft Versus Host Disease

All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

Cachectic patients with pancreatic cancer

BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Cachectic patients with non-small cell lung cancer

BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Cachectic COPD patients.

BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

Non-cachectic COPD patients.

BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

BAT activity: 18F-FDG PET-MRI-imaging. Body composition: DXA scanning, D2O and MRI. Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

Systemic inflammatory profile: blood sampling. Resting metabolic rate: indirect calorimetry. Physical activity level: accelerometry. Total daily energy expenditure: double-labeled water.

18F-FDG PET-MRI-imaging

Body composition: DXA scanning, D2O and MRI.

DXA scanning

Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.

Abdominal subcutaneous adipose tissue biopsy

Systemic inflammatory profile: blood sampling.

Blood sampling

Resting metabolic rate: indirect calorimetry.

Indirect calorimetry

Accelerometry

Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.

Double-labeled water

Annemie Schols, PhD

To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.

This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI.

Brown Adipose Tissue Activity and Energy Metabolism in Cachexia

Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease

The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning.

Detailed body composition phenotyping of cachexia by (PET-)MRI to compare with commonly applied clinical measures (D2O and DXA)

Maastricht University Medical Center

Immune System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Skin and Connective Tissue Diseases

Autoimmune Diseases

Diabetes Mellitus

Arthritis

Anorexia

Anorexia Nervosa

Arthritis, Juvenile

Inflammatory Bowel Diseases

Intestinal Diseases

Joint Diseases

Gastroenteritis

Signs and Symptoms, Digestive

Feeding and Eating Disorders

Mental Disorders

Psychotic Disorders

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Patients with juvenile idiopathic arthritis, type 1 diabete mellitus, inflammatory bowel diseases, anorexia nervosa, cancer survivor

Patients will be separated in different subgroups. Subgroups will be constituted according the disease status (i.e. active vs inactive) to assess the impact of the pathology on physical fitness and according to treatments to assess the effect of treatment on physical fitness.

indirect calorimetry

Lise LACLAUTRE

Etienne MERLIN

Justyna KANOLD

Daniel TERRAL

Stéphane ECHAUBARD

Nicolas KARON

Corinne BORDERON

Florentina IFSAN

Eric DORE

Isabelle PETIT

The aim of the present project is to assess the effects of the chronic diseases and their associated treatments chronic paediatric diseases (CPD), to further understand their impact on physical fitness for public health perspectives. This is an innovative approach in the treatment of chronic paediatric diseases . This project should yield results that help improving treatments for children and adolescents with chronic paediatric diseases throughout physical activity as therapy, reduced pain, fatigue and inflammation, and improvement in physical fitness and life quality. The originality and novelty of this project is to combine architectural, functional and metabolic components of skeletal muscle to further understand the impact of chronic paediatric diseases as a function of treatment, disease activity and maturation status (prepubertal, pubertal or post pubertal).

This study will aim at assessing muscular function (force production capacity and fatigability) in specific or ecologic situations so as to get information about muscle functioning on isolated muscle group (here knee extensors) or during whole body exercise. Moreover, results arising from muscle architecture or quality will allow understanding the decrease in strength or endurance reported in the literature. The data collected will allow us to further understand the impact of the disease on structural, functional and metabolic parameters. Finally, the understanding of these alterations will provide information enabling to establish recommendations in physical activity (PA) to reduce or even counter the effect of the chronic inflammation and prevent at long-term overweight and cardiovascular risks.

The long-term objective is to contribute establishing recommendations or guidelines for prescribing physical activity during medical therapy. Values obtained in pathological children will be compared to those of control children matched for gender and maturation.

Patients will be separated in different subgroups. Subgroups will be constituted according the disease status (active vs inactive) to assess the impact of the pathology on physical fitness and according to treatments to assess the effect of treatment on physical fitness.

Patients will perform physical tests to provide information about their physical fitness (body composition, metabolic flexibility, muscle strength and fatigue, bone mineral density), which will be compared to age- and gender-matched healthy controls. Patients will also complete blood tests to provide information about their inflammatory state to best understand physiological disorders and allow a better classification of the disease status.

1. Metabolic flexibility assessment

   After sitting quietly for 20 min, subjects will perform a graded exercise test to volitional fatigue on an electromagnetically braked cycle ergometer with continuous gas collection and heart rate monitoring. In all subjects, when the Respiratory Exchange Ratio will be ≥1.00, indicating zero fat oxidation, the work rate will be increased by the same increments at 1-min intervals until volitional fatigue. O2 consumption (VO2) peak will be considered maximal when the Respiratory Exchange Ratio will be ≥1.05 and the subject will achieve his age-predicted maximal heart rate \[heart rate maximum: (220 - age)\]. Indirect calorimetry, as will be used in this study, is the standard method to quantify substrate oxidation rates at rest and during exercise. O2 consumption (VO2) and CO2 production (VCO2) will be averaged over the final 1 min of each work rate, and the results of this test will be used to calculate fat oxidation over a wide range of exercise intensities for each subject with the equations:

   Lipids (mg.min-1) = 1.6946 x VO2 - 1.7012 x VCO2 and CHO (mg.min-1) = 4.585 VCO2 - 3.2255 VO2.
2. Muscle architecture Subjects will be lied on a massage table, muscle relaxed. Ultrasound will be used on vastus lateralis (VL), vastus medialis (VM) and rectus femoris (RF) to assess muscle architecture. The muscle belly will be measured according to Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) recommendations. Muscle thickness (the distance between superior and inferior aponeurosis) and fascicule angle (the angle formed by muscle fascicule and the inferior aponeurosis) will be measured for each muscle.
3. Muscle quality Subjects will sit on an adjustable seat. The right tight will be placed into the antenna of the peripheral quantitative tomography, so that the femoral condyles are aligned with the laser. An antero-posterior scout-view will be performed to detect junction between tibial tray and the femur, which matched with the starting position of the measurement. Then, a measure will be performed at 40% of the length between the greater trochanter and the mid-patella of the right leg. Muscle cross sectional area (CSA) and intramuscular adipose tissue (IMAT) will be assessed. The measurements will be performed by the same investigator to avoid any inter-individual bias.
4. Muscle function

   o Vertical jump height: Subjects will have to perform a series of vertical jumps. Subjects will perform two squat jumps (SJ) and two counter movements jumps (CMJ) using an OptoJump following standardised guidelines. For SJ, subjects will have to flex their knee at 90° with the hand on the hip to avoid any counter movements induced by the upper limbs. Subjects will have to maintain the position for 3-s. The guidelines for CMJ will be similar, but without short break between standing and flexing positions. For both exercises, subjects will have to jump as high as possible. Vertical jump height will be calculated according the formula where T is time flight duration and g the acceleration of 9.81 m.s-2 of gravity.

   o Maximal voluntary strength: Subjects will sit on an isokinetic dynamometer with a hip angle of 40° (0°= standing position). Upper body will be strapped on the chair back and subjects will have to grip the chair to avoid any counter-movements. Their right ankle will be strapped and connected to a force sensor. After a standardised warm up consisting of repeating isometric contractions at increasing intensities, patients will have to perform maximal voluntary isometric contractions (MVIC). MVIC will be performed at different randomized joint angles (29°, 66°, 76°, 87° and 103° \[0° = full extension\]) to determine the optimal angle producing maximal strength. Two measurements will be performed at each angle to check the reproducibility. A third trial will be performed if the difference between both measurements is higher than 5%. Subjects will be vigorously encouraged to produce maximal voluntary strength during isometric contractions. Root Mean Square (RMS) values will be calculated from the electromyographic (EMG) activity recorded on VL, VM and RF.
5. Muscle fatigue Muscle fatigue will be assessed with the same method as previously described. For this test, patients will have to maintain a force level corresponding to 50% MVIC to avoid any knee pain. The exercise will be stopped when subjects will be unable to maintain the force level more than 3-s despite vigorous encouragements. Time duration to task failure will be measured.
6. Bone micro-architecture Bone micro-architecture will be assessed through bone mineral density, trabecular and cortical density. This measurement will be performed in the same time that muscle quality assessment by pQCT. Patients will be placed in the same position. Two measurement will be done using pQCT at 20% and 40% of the tight. Micro-architectural parameters (trabecular and cortical density) will be calculated.
7. Body composition Body composition will be assessed by Dual-energy X-ray absorptiometry. Fat and fat-free mass, and bone density will be measured for the whole body and segments (arm, leg and trunk).
8. Biology Blood samples will be drawn once a year for patients and once for controls. Blood samples will allow to assess NFS (blood formul numeration), ionogramme, CRPus, VS, total bilirubin, ASAT, ALAT, GGT, PAL, glycaemia, total cholesterol -HDL-LDL, triglycerid, TSH, T4, adiponectin et leptin. Lipidomic, Cytokines and their receptors, calgranulins and MicroARNs will be also assessed thereafter.

Health and Exercise Response in Children With Chronic and Auto-immune Pathologies

Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.

Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children

muscle cross sectional area (mm2) evaluated by peripheral Quantitative Computed Tomography (pQCT)

fat mass (g.cm²) evaluated by Dual-energy X-ray absorptiometry

Percentage variation of time to task failure duration during isometric contraction between pathological and healthy children.

blood level of inflammation markers (IL-17)

blood level of inflammation markers (CRP)

blood level of inflammation markers (IL-6)

blood level of inflammation markers (TNF - a)

blood level of inflammation markers (IL-10a)

blood level of inflammation markers (INF)

blood level of inflammation markers (calprotectin)

Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

INSERM CIC 1405

University Hospital, Clermont-Ferrand

Facies

Q-NRG®

Clinicians need to measure energy expenditure (EE) by indirect calorimetry (IC) to optimize nutritional support for a better clinical outcome, especially in patients with chronic conditions or with high risk of under- and over- feeding. However, IC is rarely used in clinical routine because the devices currently on the market are of tedious use, imprecise and expensive. An easy-to-use, accurate and inexpensive IC device (Q-NRG® CE marking n°MED 9811) has been developed to meet specifications made by and for clinicians. The ease of use of this new IC device has been first evaluated in mechanical ventilation mode. This second phase aims at evaluating the ease of use, the stability and the feasibility of the measurements with this new IC device in canopy and face mask modes for spontaneously breathing adult patients.

This study aims at evaluating the ease of use, the stability and the feasibility of EE measurements with the new IC device in spontaneously breathing adult patients with malnutrition, cancer, surgery or haemodialysis, using the canopy and face mask modes.

Patient data will be obtained from the medical records before EE measurement. EE measurement will be performed sequentially with the Q-NRG® and the IC device currently used in each study center. Patient data input, calibration, installation of face mask or canopy hood on the patient, and EE measurement recording will be performed according to the procedure stated in their respective user manual. Time needed to perform EE will be calculated afterwards from the time the IC device is turned on to EE measurement reaches a steady state with a variation ≤10%.

In a subset of 15 subjects, accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® will be assessed by comparison with the reference method consisting in a mass spectrometer.

The ICALIC 2 International Multicentric Study

Clinical Evaluation of the Ease of Use of a New Indirect Calorimeter in Canopy and Face Mask Modes for Energy Expenditure Measurement: The ICALIC 2 International Multicentric Study (Second Phase)

Accuracy of gas composition (O2 and CO2) measurement by the Q-NRG® assessed by comparison with a mass spectrometer.

Time needed to perform EE will be calculated from the time the Q-NRG® or the currently used calorimeter is turned on to EE measurement reaches a steady state with a variation ≤10%.

Accuracy and precision of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.

The stability of VO2, VCO2, RQ and EE measurements with the Q-NRG® in face mask or canopy mode will be compared to currently used indirect calorimeters.

Clinical conditions, if any, precluding or disturbing the EE measurement with the Q-NRG®.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia	NCT02500004	Cachexia Neoplasms Pulmonary Disea... Pancreatic Neop...	18F-FDG PET-MRI... DXA scanning Abdominal subcu... Blood sampling Indirect calori... Accelerometry Double-labeled ...	30 Years -	Maastricht University Medical Center
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia	NCT02500004	Cachexia Neoplasms Pulmonary Disea... Pancreatic Neop...	18F-FDG PET-MRI... DXA scanning Abdominal subcu... Blood sampling Indirect calori... Accelerometry Double-labeled ...	30 Years -	Maastricht University Medical Center
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia	NCT02500004	Cachexia Neoplasms Pulmonary Disea... Pancreatic Neop...	18F-FDG PET-MRI... DXA scanning Abdominal subcu... Blood sampling Indirect calori... Accelerometry Double-labeled ...	30 Years -	Maastricht University Medical Center
Health and Exercise Response in Children With Chronic and Auto-immune Pathologies	NCT03913962	Juvenile Idiopa... Diabetes Inflammatory Bo... Cancer Survivor Anorexia Nervos...	indirect calori...	6 Years - 18 Years	University Hospital, Clermont-Ferrand
The ICALIC 2 International Multicentric Study	NCT03947294	Cancer Surgery Hemodialysis	Q-NRG®	18 Years -	University Hospital, Geneva
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia	NCT02500004	Cachexia Neoplasms Pulmonary Disea... Pancreatic Neop...	18F-FDG PET-MRI... DXA scanning Abdominal subcu... Blood sampling Indirect calori... Accelerometry Double-labeled ...	30 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for indirect calorimetry