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Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy

20 septembre 2019 mis à jour par: VA Office of Research and Development

Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy

This study will determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Purpose: A single-site, randomized, blinded, prospective clinical trial is proposed to determine the significance of a combined isokinetic strength and aerobic exercise training program on the rehabilitation of peripheral nerve function in Type 2 diabetic veterans and non-veterans with neuropathy. Background and Significance: Obesity is a major factor in the increasing rates of diabetes and its related complications. Diabetes affects greater than 7% of the population. Veterans are at even greater risk, with approximately 16% currently receiving treatment at Department of Veterans Affairs Medical Centers for diabetes. More than half of affected veterans experience debilitating complications of diabetes, including peripheral neuropathy (PN). Exercise training, in combination with pharmacologic intervention, is now recognized as a cornerstone of management for diabetes. Therapeutic interventions currently available for the treatment of PN in diabetic patients are limited, however, to pain management and stringent glycemic control. Exercise is reported to significantly decrease peripheral nerve microvascular complications common among chronic diabetics. Our preliminary findings demonstrate that exercise intervention improves peripheral nerve function in the diabetic veteran with PN. Intervention strategies, such as proposed in this application, offer a unique and novel therapeutic option for the rehabilitation of the neuro-compromised Type 2 diabetic veterans and non-veterans. Methods & Research Plan: One-hundred subjects will be recruited for this 24-week study. Subjects each will be randomly assigned to aerobic, isokinetic strength training, combined aerobic and strength training, or non-exercise (control) intervention groups. Isokinetic strength training (Biodex System 3), aerobic exercise training (treadmill), or the combination of strength and aerobic training will be administered 3x per week for the initial 12 weeks. Control subjects will receive 12 clinical visits over the course of the initial 12 weeks. The effects of exercise training type, compared with control subjects, on recovery of peripheral nerve function will be rigorously determined from baseline, 12- and 24-week testing using electrodiagnostic primary outcome measures, Quantitative Sensory Testing, and a battery of validated qualitative and quantitative secondary outcome measures that include an incremental symptom-limited treadmill test, peak torque, Total Neuropathy Score, visual analogue pain scale, and quality of life SF-36V Health Survey. Sustainability of effect will be determined at 24-weeks.The individual effects of exercise training type, compared with control subjects, on tissue oxygenation will be determined from baseline, 12- and 24-week testing by non-invasive quantitated infrared spectroscopy using an InSpectraTM Tissue Spectrometer. Expected Outcomes: This study will objectively and critically determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran. Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Illinois
      • Hines, Illinois, États-Unis, 60141-5000
        • Edward Hines Jr. VA Hospital, Hines, IL

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

45 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus
  • stable blood glucose control
  • clinical findings consistent with length-dependent sensorimotor polyneuropathy, stage N2a

Exclusion Criteria:

  • foot ulceration
  • unstable heart disease
  • co-morbid conditions limiting exercise
  • disorders of the central nervous system causing weakness or sensory loss
  • received treatment with medications known to have neuropathy as a prominent side effect including vincristine, vinblastine, cis-platin, and paclitaxel
  • medical conditions that may be associated with neuropathies such as alcoholism, liver disease, kidney disease, toxic exposure, vitamin deficiency, autoimmune disorders, cancer, or hypothyroidism

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Arm 1
Sedentary Control Group
Expérimental: Arm 2
Aerobic Exercise Group
Comportemental: Exercise
Structured aerobic exercise (treadmill).
Comportemental: Exercise
Structured isokinetic strength exercise (dynameter).
Expérimental: Arm 3
Isokinetic Strength Exercise Group
Comportemental: Exercise
Structured aerobic exercise (treadmill).
Comportemental: Exercise
Structured isokinetic strength exercise (dynameter).
Expérimental: Arm 4
Combined Aerobic and Isokinetic Strength Exercise Group
Comportemental: Exercise
Structured aerobic exercise (treadmill).
Comportemental: Exercise
Structured isokinetic strength exercise (dynameter).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sural Nerve Amplitude
Délai: Baseline, 12, and 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12, and 24 weeks
Sural Nerve Latency
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Sural Nerve Conduction Velocity
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Tibial Nerve Amplitude
Délai: Baseline, 12 weeks, 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 weeks, 24 weeks
Tibial Nerve Latency
Délai: Baseline, 12 weeks, 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 weeks, 24 weeks
Tibial Nerve Conduction Velocity
Délai: Baseline, 12 weeks, 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 weeks, 24 weeks
Sensory Median Nerve Amplitude
Délai: Baseline, 12, and 24 weeks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12, and 24 weeks
Sensory Median Nerve Latency
Délai: Baseline, 12wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12wks, 24 wks
Sensory Median Nerve Conduction Velocity
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Sensory Ulnar Nerve Amplitude
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Sensory Ulnar Nerve Latency
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Sensory Ulnar Nerve Conduction Velocity
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Peroneal Nerve Amplitude
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Peroneal Nerve Latency
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks
Peroneal Nerve Conduction Velocity
Délai: Baseline, 12 wks, 24 wks
Maximal responses were obtained using percutaneous electrical stimuli. Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities. A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies. The patients dominant side was chosen. In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen. In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
Baseline, 12 wks, 24 wks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Symptom-Limited TMT Blood Glucose Response
Délai: Initial entry into study, 12 and 24 weeks
Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)
Initial entry into study, 12 and 24 weeks
Short Form-36V: Physical Component Score
Délai: Initial entry into study, 12 and 24 weeks
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Physical Component scores reflect perceived changes in physical health relative to the previous year.
Initial entry into study, 12 and 24 weeks
Voluntary Duration of Symptom-Limited TMT
Délai: baseline, 12-wks, 24-wks
Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)
baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Heart Rate
Délai: baseline, 12-wks, 24-wks
Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Systolic Blood Pressure
Délai: Baseline, 12-wk, 24-wk
Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Baseline, 12-wk, 24-wk
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Délai: Baseline, 12-wks, 24-wks
Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Délai: Baseline, 12-wks, 24-wks
Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Baseline, 12-wks, 24-wks
Maximum Respiratory Exchange Ratio (RER) During TMT
Délai: Baseline, 12-wks, 24-wks
Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT). This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2.
Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Délai: Baseline, 12-wks, 24-wks
Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
Baseline, 12-wks, 24-wks
Symptom-Limited TMT Maximum METS Achieved (MET)
Délai: Baseline, 12-wks, 24-wks
Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT). One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female). A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising. Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest.
Baseline, 12-wks, 24-wks
Short Form-36V: Mental Component Score
Délai: initial entry into study, and at 12-wks and 24-wks
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life. This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals. Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table. Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health. Mental Component scores reflect perceived changes in emotional health relative to the previous year.
initial entry into study, and at 12-wks and 24-wks

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Height
Délai: baseline
Height of subjects upon entry into study
baseline
Weight
Délai: Baseline, 12-wks, 24-wks
Weight of subjects at baseline, 12-weeks, and 24-weeks
Baseline, 12-wks, 24-wks
Body Mass Index (BMI)
Délai: Baseline, 12-wk, 24-wk
BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m).
Baseline, 12-wk, 24-wk
Duration of Diabetes Mellitus
Délai: Baseline
Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study
Baseline
HbA1C Laboratory Values
Délai: Baseline, 12-wk, 24-wk
Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk
Baseline, 12-wk, 24-wk
Triglyceride Laboratory Values
Délai: Baseline
Laboratory triglyceride values at baseline entry into study
Baseline
Cholesterol Laboratory Values
Délai: Baseline
Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study
Baseline
Creatinine Laboratory Values
Délai: Baseline
Laboratory creatinine values at baseline entry into study
Baseline
Blood Urea Nitrogen (BUN) Laboratory Values
Délai: Baseline
Laboratory Blood Urea Nitrogen levels at baseline entry into study
Baseline
Aspartate Aminotransferase Laboratory Values
Délai: Baseline
Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study
Baseline
Thyroid Stimulating Hormone Laboratory Values
Délai: Baseline
Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study
Baseline
Age
Délai: at baseline
Age of participants at entry into study.
at baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

VA Office of Research and Development

Les enquêteurs

  • Chercheur principal: Evan Stubbs, Edward Hines Jr. VA Hospital, Hines, IL

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 janvier 2010

Achèvement primaire (Réel)

14 novembre 2014

Achèvement de l'étude (Réel)

14 novembre 2014

Dates d'inscription aux études

Première soumission

6 août 2009

Première soumission répondant aux critères de contrôle qualité

7 août 2009

Première publication (Estimation)

10 août 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 septembre 2019

Dernière vérification

1 septembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • B6954-R
  • I01RX000130 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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