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Taurine and Nitrate Supplementation on Thermoregulatory in T2DM

12 giugno 2026 aggiornato da: Ant Shepherd, University of Portsmouth

The Effect of Taurine and Nitrate Supplementation on Thermoregulatory Responses in People With Type 2 Diabetes Mellitus.

Anthropogenic warming is increasing the frequency and intensity of extreme heat events. Elevated temperatures raise the risk of mortality and hospital admissions, particularly among people with chronic illnesses such as type 2 diabetes mellitus (T2DM). Globally, around 530 million people live with T2DM , and in the United Kingdom nearly six million are affected, creating a substantial population vulnerable to heat related illness.

People with T2DM are at heightened risk of cardiovascular disease, which can impair cardiac output, a key component of thermoregulation, as it supports increased skin blood flow for heat dissipation. T2DM also attenuates eccrine sweat gland function, peripheral vasodilation, reducing evaporative cooling capacity. These physiological constraints highlight the need for effective strategies to improve heat tolerance in this group.

Recent evidence shows that exogenous taurine supplementation can enhance sweating in healthy individuals, potentially improving heat loss. This study will examine whether acute taurine supplementation, alone or combined with beetroot, can limit rises in core temperature in people with T2DM during an acute extreme heat exposure.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Anthropogenic warming is increasing the likelihood of extreme heat events. These events, defined as periods of abnormally hot weather lasting several consecutive days, are predicted to rise in both temperature and frequency . Extreme heat increases global mortality with people suffering from chronic conditions being especially vulnerable. A growing body of evidence suggests excess mortality may partly result from increased cardiovascular strain. This is particularly relevant for people with Type 2 Diabetes Mellitus (T2DM) who have both an elevated cardiovascular mortality risk independent of heat stress and a compromised ability to regulate their body temperature during heat stress . This likely explains the increase in hospitalisation and mortality in people with T2DM typically observed during heat waves.

People with T2DM are characterised by progressive insulin resistance over a sustained period, reducing the body's ability to effectively metabolise glucose leading to chronic hyperglycaemia. Consequences of chronic hyperglycaemia are micro and macrovascular dysfunction which lead to an increase in cardiovascular disease (CVD) risk and mortality. Heat stress also produces greater heat strain in people with T2DM compared to the rest of the population . This is potentially derived through an attenuated thermoregulatory response to heat stress in people with T2DM, reducing heat dissipation due to impaired sweating, endothelial and cardiac function , skin blood flow and nitric oxide (NO) bioavailability. These factors increase the risk of heat-related illness. Importantly, advanced heat illness is driven in part by systemic inflammation which highlights the need for targeted interventions that can support endogenous anti inflammatory defences in individual with T2DM during exposure to high heat events.

One such intervention may be supplementation with taurine, an amino acid. Taurine shows promise as a thermoregulatory aid during extreme heat, as it promotes faster onset of sweating, greater sweat loss, reduced heat accumulation and enhanced evaporative cooling in healthy populations. As an antioxidant, taurine may also improve inflammation and redox balance by increasing NO bioavailability via increased stability of tetrahydrobiopterin (BH4) in NO synthase and reduced NO scavenging. Beetroot is another antioxidant rich supplement that also increases the bioavailability of NO via the stepwise reduction of nitrate to nitrite and subsequently to NO. Ultimately, this will improve macro and microvascular function in people with chronic disease and may help with thermoregulation during extreme heat. Taurine and nitrate are well tolerated even at high doses in long term clinical trials, whilst taurine's and nitrates capacity to stabilise mitochondrial function provides a biologically plausible means of reducing heat induced oxidative stress.

Taurine and nitrate may therefore offer safe, low-cost interventions to reduce oxidative stress and inflammation, to enhance blood flow and improve evaporative heat loss during heat stress. We hypothesise that taurine and nitrate supplementation will improve the sweating response and reduce the rate of core temperature rise compared to placebo in people with T2DM after exercise in acute heat event. Secondary hypotheses are that the supplements will improve: (1) macro and micro vascular function (2), skin blood flow and (3) redox balance.

Tipo di studio

Interventistico

Iscrizione (Stimato)

18

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Male or female (post-menopausal) aged 35 years or above.
  • Diagnosed with T2DM as defined by the WHO (HbA1c ≥48 mmol/mol).
  • Willing and able to give informed consent for participation in the study.
  • Able to understand and fully cooperate with the study protocol.

Exclusion Criteria:

  • Severe peripheral neuropathy (to the point to which they cannot sense temperature)
  • Uncontrolled hypertension (≥180 systolic / 100 diastolic)
  • Significant renal impairment (eGFR < 30)
  • Diagnosed anhidrosis
  • Taking any medication which may interfere with data interpretation or safety
  • Who have had a myocardial infarction or cerebrovascular event
  • Any cardiac abnormalities which restrict hard exercise
  • Any allergies to the ingredients used in the supplements
  • BMI >40
  • Current smokers or who have stopped within 3 months
  • Unable to understand and/or fully cooperate with the study protocol
  • Any serious medical condition which would interfere with data interpretation or safety will be excluded from participation.
  • Open wounds
  • Skin ulcerations (that would interfere with data collection and interpretation or safety)
  • Eczema (that would interfere with data collection and interpretation or safety)
  • Pre-existing postural hypertension
  • Existing cardiac diseases (identified during screening)
  • Currently heat acclimated (repeated exposure to hot environments ≥3 sessions in the last 14-21 days)
  • Prior heat related illness

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Placebo will include the 20g nitrate placebo from above and 5g of maltodextrin (100% Maltodextrin Carbs, myprotein, UK) which will also be added to 305 mL water.
Integratore alimentare: taurine
The taurine supplement will be administered as a 5g (100% taurine powder, myprotein, UK) dose. To taste match the beetroot arm we will use a nitrate depleted powder. The placebo contained 1.6% nitrate (180 mg nitrate; Bio-gen Extracts Private Limited, Karnataka, India). The servings contained 13.33g of nitrate depleted beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic & citric acid). The beetroot powders were prepared by manipulating the processing control parameters (extraction time and temperature) during extract preparation to ensure precise nitrate concentration across the different conditions, particularly for the placebo. Specifically, raw beetroot was extracted with water for 1 h at >90°C with the residue obtained from the first extraction processed to obtain the low nitrate grade material. The NO3- content of beetroot powders were determined by treating the samples with a salicylic acid-sulphuric acid mixture,
Integratore alimentare: Beetroot and taurine
20g of formulated beetroot power containing ~6% nitrate (800mg NO3-; TruBeet; Bio-gen Extracts Private Limited). The servings contained 13.33g of the formulated beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic & citric acid) and 5g (100% taurine powder, myprotein, UK) of taurine will also be added to 305mL water prior to ingestion.
Integratore alimentare: Placebo
Placebo will include the 20g nitrate placebo from above and 5g of maltodextrin (100% Maltodextrin Carbs, myprotein, UK) which will also be added to 305 mL water.
Comparatore attivo: Taurine
The taurine supplement will be administered as a 5g (100% taurine powder, myprotein, UK) dose. To taste match the beetroot arm we will use a nitrate depleted powder. The placebo contained 1.6% nitrate (180 mg nitrate; Bio-gen Extracts Private Limited, Karnataka, India). The servings contained 13.33g of nitrate depleted beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic & citric acid). The beetroot powders were prepared by manipulating the processing control parameters (extraction time and temperature) during extract preparation to ensure precise nitrate concentration across the different conditions, particularly for the placebo. Specifically, raw beetroot was extracted with water for 1 h at >90°C with the residue obtained from the first extraction processed to obtain the low nitrate grade material. The NO3- content of beetroot powders were determined by treating the samples with a salicylic acid-sulphuric acid mixture
Integratore alimentare: taurine
The taurine supplement will be administered as a 5g (100% taurine powder, myprotein, UK) dose. To taste match the beetroot arm we will use a nitrate depleted powder. The placebo contained 1.6% nitrate (180 mg nitrate; Bio-gen Extracts Private Limited, Karnataka, India). The servings contained 13.33g of nitrate depleted beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic & citric acid). The beetroot powders were prepared by manipulating the processing control parameters (extraction time and temperature) during extract preparation to ensure precise nitrate concentration across the different conditions, particularly for the placebo. Specifically, raw beetroot was extracted with water for 1 h at >90°C with the residue obtained from the first extraction processed to obtain the low nitrate grade material. The NO3- content of beetroot powders were determined by treating the samples with a salicylic acid-sulphuric acid mixture,
Integratore alimentare: Placebo
Placebo will include the 20g nitrate placebo from above and 5g of maltodextrin (100% Maltodextrin Carbs, myprotein, UK) which will also be added to 305 mL water.
Comparatore attivo: Beetroot and Taurine
20g of formulated beetroot power containing ~6% nitrate (800mg NO3-; TruBeet; Bio-gen Extracts Private Limited). The servings contained 13.33g of the formulated beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic & citric acid) and 5g (100% taurine powder, myprotein, UK) of taurine will also be added to 305mL water prior to ingestion.
Integratore alimentare: Beetroot and taurine
20g of formulated beetroot power containing ~6% nitrate (800mg NO3-; TruBeet; Bio-gen Extracts Private Limited). The servings contained 13.33g of the formulated beetroot powder. The remaining 6.67g comprised a sweetener (stevia), flavour (watermelon) and flavouring agents (malic & citric acid) and 5g (100% taurine powder, myprotein, UK) of taurine will also be added to 305mL water prior to ingestion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Whole body sweat rate
Lasso di tempo: Baseline and immediately post heating (3 hour post-baseline)

WBSR will be measured by taking a nude body mass (kg). Participants will be shown to a private changing facility in which the scales (Industrial Electronic Weight Indicator, Model 10, Ohaus Corporation, Parsippany, NJ, US) are located, with the screen for the value reading located outside to ensure privacy of the participant. The pre-mass measure will occur during every experimental visit, before the instrumentation section of the visit. Towel dried nude body mass will then be recorded once de-instrumentation has occurred. The equation below will be used to calculate WBSR.

WBSR (L/h) equation:

(Pre body mass (kg) - Post body mass (kg)) + Fluid intake (L) - Urine output (L) Duration of test (hrs)
Baseline and immediately post heating (3 hour post-baseline)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Local sweat rate:
Lasso di tempo: through study completion, average 1 week
The Q-sweat (Qsweat Quantitative Sweat Measurement System, WR Medical Electronics Co., Minnesota, USA) will be used to understand LSR during the heat event. Participants will be instrumented with the ventilated sweat capsule and placed on the upper back (mid scapula) and onto the mid anterior forearm. Additionally, measuring the forearm may provide insight into regional differences and any autonomic dysfunction in sudomotor response. This will be measured continuously throughout the investigation through the software TestWorks (TestWorks software, WR Medical Electronics Co., Maplewood, MN, USA). Live data will be gathered during the trials and subsequent data will be processed into one-minute averages across each trial.
through study completion, average 1 week
Rectal temperature Trec
Lasso di tempo: through study completion, average 1 week
Trec will be measured continuously (1s intervals) throughout each trial. This will be measured via a rectal thermistor (PROACT Temperature Probes, Northamptonshire, United Kingdom).
through study completion, average 1 week
Skin temperature: Tsk
Lasso di tempo: through study completion, average 1 week

Tsk will be assessed using four skin thermistors (Grant Instruments, Cambridge, UK), at the sites on the right side of the body at the locations, pectoralis major, biceps brachii, mid-thigh and the gastrocnemius. Thermistors will be placed during the instrumentation part at the start of the protocol and will remain on location until the session has concluded. Data will be recorded throughout the whole duration of the experimental protocol. These will be held in place by a Tegaderm™ dressing (Tegaderm™ Dressings, 3M, St. Paul, Minnesota, USA) with additional tape anchoring them to the skin to avoid movement. Minute averages will be recorded for the duration of the protocol and plotted to understand the change in temperature throughout each trial, to provide information on the specific temperatures that have been identified.

Mean skin temperature = (0.3*Tpectorlis) + (0.3*Tbicep) + (0.2*Tthigh) + (0.2*Tcalf)

*expressed as an indication of multiplication.
through study completion, average 1 week
Mean Body temperature
Lasso di tempo: through study completion, average 1 week

Mean body temperature will be measured to provide an overall measure of heat gain for the individual through the combination of Trec and Tsk. The weighting of the different measures of temperature is determined by the ambient temperature of the surrounding, as the protocol will be of a hot environment the below equation was chosen over other weightings, which is as below in Equation two (Burton et al., 2025). This will be measured at all time points that Trec and Tsk are taken in conjunction with each other. This will be measured as absolute values in degrees Celsius, for all time points and also be expressed as a delta change from the baseline temperature or between other specific time points chosen, to provide an understanding of the rate of change.

Mean body temperature = Tˉsk=0.3(Tchest+Tarm)+0.2(Tthigh+Tcalf)
through study completion, average 1 week
Cardiac output
Lasso di tempo: through study completion, average 1 week
Using thoracic bio-reactance technology (Physioflow), which will derive cardiac output at rest. Four electrodes are placed on the participant's chest between which a small, painless current is passed.
through study completion, average 1 week
Macrovascular function
Lasso di tempo: Baseline and immediately post heating (3 hour post-baseline)
Brachial artery flow mediated dilation (FMD) will be used as a measure of endothelial function. Endothelial-dependent function is assessed by measuring FMD in response to a 5 minute ischaemic stimulus, induced by forearm cuff inflation. Measurements will be performed in the supine position on the right arm with the cuff placed distal to the olecranon process. High-resolution duplex ultrasound (SonoSite Edge II, Bothell, Washington, USA) with a 12-MHz multifrequency linear array probe will be used to image the brachial artery at the distal third of the upper arm and simultaneously record the longitudinal B-mode image and Doppler blood velocity trace. The angle of Doppler insonation will be 60°. Images will be optimised, and settings (depth, focus position, and gain) will be maintained between FMD assessments within each individual visit, and the location of the transducer will be recorded and marked on the skin using an indelible marker.
Baseline and immediately post heating (3 hour post-baseline)
Microvascular function
Lasso di tempo: Baseline and immediately post heating (3 hour post-baseline)
Briefly, following cleaning of the skin surface with water for injection, two perspex rings will be attached to the skin with one acting as an anode, and the other as the cathode. These electrodes will be connected to the iontophoresis controller (MIC 2, Moor Instruments, UK). Both chambers have an 8 mm inner diameter. The anode chamber will be filled with ~ 0.5 mL of ACh (Braun, Melsungen, Germany), with a 1% concentration dissolved in water for injection. The cathode chamber will be filled with ~ 0.5 mL of SNP (Sigma-aldirch, Missouri, USA) with a 0.01% concentration dissolved in water for injection. The protocol for electrical pulses included: four at 25 μA, followed by a single pulse of 50 μA, 100 μA, 150 µA and 200 µA. These pulses will last for 20 seconds with 120 seconds intervals between each pulse where no current will be applied. An interval of five minutes will be given between testing each site (forearm, finger and foot).
Baseline and immediately post heating (3 hour post-baseline)
Heart rate
Lasso di tempo: through study completion, average 1 week
During the experimental visits participants will wear a Heart Rate monitor (Polar M430, Kempele, Finland) which will continually record data throughout the session. It will be fitted during the instrumentation section of the protocol. This will provide real time data on participants current HR and allow assessment of the task demands placed on the individual. HR will be averaged to one-minute intervals upon analysis of the data.
through study completion, average 1 week
Biomarkers
Lasso di tempo: Baseline and immediately post heating (3 hour post-baseline)
blood samples will be collected through venepuncture of a vein in the cubital fossa. The collection of the plasma during the investigation session will be taken pre and post simulated heat events. Sample will be drawn at each specified visit/time point into ethylenediaminetetraacetic acid (EDTA) tube (K2, BD, USA) for analysis of plasma [Taurine] and [cysteine], (inflammation markers) [IL-6], [IL-10], [TNF-α], (intestinal permeability), [LBP] and [iFABP] and into lithium heparin (K2, BD, USA) tubes for [nitrate] and [nitrite].
Baseline and immediately post heating (3 hour post-baseline)
Muscle peripheral oxygenation
Lasso di tempo: through study completion, average 1 week
Near-infrared spectroscopy (NIRS) will be used to measure oxygenation at the periphery of the medial gastrocnemius. Instrumentation and recording of the measure will be done in accordance with previous published methodology in consuming ketone drink for people with T2DM which is as followed. The NIRS device (NIRS; Portamon Artinis Medical Systems, The Netherlands) will be placed 10 cm inferior to the tibial tubercle and 10 cm lateral to the anterior tibial crest. Upon measurement completion, cleaning and shaving (if required) of the area will be undertaken following marking of the area to ensure correct placement of the device. These measures and markings will take place during trial visits. Participants will be shown the device and where it will be placed during the familiarisation visit. Supporting tape will hold the device in place with a darker colour dressing placed over the device to minimise the light affecting the data.
through study completion, average 1 week
Hydration levels:
Lasso di tempo: Baseline and immediately post heating (3 hour post-baseline)
Participants will be required to provide a urine sample on entry to the laboratory on experimental visits. This will be measured via an osmolality device [Osmocheck, Vitech Scientific, West Sussex, UK] to ensure hydration levels are below >600 mOsm kg-1, for euhydration (Oppliger et al., 2005). Upon obtaining the sample, a pipette will be used to aliquot the urine onto the prism surface of the sensor well. Should hydration levels be greater than this, participants will be required to consume 500 ml of water and wait 30 minutes (Page et al., 2019) before being able to enter the simulated heat event. Participants will be asked to consume 500 ml of water before entering the laboratory on experimental days (Kirby et al., 2024; Notley et al., 2021). After the experimental sessions, participants will provide a further urine sample (if possible), to assess dehydration pre and post simulated heat event.
Baseline and immediately post heating (3 hour post-baseline)
Thermal sensation
Lasso di tempo: through study completion, average 1 week
Thermal sensation will be assessed during the investigation to provide a subjective rating of how the participants are feeling within the environment. For thermal comfort participants will be asked to rate their perception of satisfaction of the environment from their state of mind. For thermal sensation, participants will be asked to rate their perception of the sensory feeling of the environment around them. Both questions will be measured on a six-point and six-point scale respectively. This will provide a more in detail understanding of the sensory and state of mind of thermal perception. Participants will be provided with a pen and will be asked to draw a line onto the scale regarding their answer. This will then be measured on a visual analogue scale, and be recorded in cm (Stevens et al., 2025). The marker location will be taken as the uppermost and leftmost extent of the ink marking drawn by participants.
through study completion, average 1 week
Heat illness index:
Lasso di tempo: through study completion, average 1 week

The heat illness symptom index (HISI) will be a perceptual based measure used during the experimental protocol. This measure will be used to assess the risk from the heat exposure that may be being experienced by the participant. The measure will allow a greater informed decision making in the safety of the participant during the simulated heat event. Participants will be encouraged throughout to express any feelings of discomfort or illness at any moment and not waiting for the index measure to take place. This will be measured at baseline (room temperature) upon entry and exit of the environmental chamber, every ten minutes.

Higher HISI = worse (more severe heat illness symptoms) Lower HISI = better (fewer or no symptoms)

Each symptom is score on a scale of, 0, 1, 2 and 3.
through study completion, average 1 week
Rate of perceived exertion
Lasso di tempo: through study completion, average 1 week
The scale that will be used is the Borg (1982) rate of perceived exertion (RPE) scale ranging from 6 (no exertion at all) to 20 (maximal exertion). This measure is widely established scale and will be used to help understand how physically demanding the participants are experiencing the protocol. This will be measured in accordance with the timings of the perceptual measures of heat stress. Participants will be familiarised with this scale during the baseline visit. During the experiment, participants will be asked to verbally tell the research team which number on the scale that is currently being experienced.
through study completion, average 1 week
Stroke volume
Lasso di tempo: through study completion, average 1 week
Using thoracic bio-reactance technology (Physioflow), which will derive stroke volume at rest. Four electrodes are placed on the participant's chest between which a small, painless current is passed.
through study completion, average 1 week
total peripheral resistance
Lasso di tempo: through study completion, average 1 week
Using thoracic bio-reactance technology (Physioflow), which will total peripheral resistance, at rest. Four electrodes are placed on the participant's chest between which a small, painless current is passed.
through study completion, average 1 week
heart rate
Lasso di tempo: through study completion, average 1 week
Using thoracic bio-reactance technology (Physioflow), which will derive heart rate at rest. Four electrodes are placed on the participant's chest between which a small, painless current is passed.
through study completion, average 1 week
Thermal comfort
Lasso di tempo: [Time Frame: through study completion, average 1 week]
Thermal comfort will be used during the investigation to provide a subjective rating of how the participants are feeling within the environment. For thermal comfort participants will be asked to rate their perception of satisfaction of the environment from their state of mind. For thermal sensation, participants will be asked to rate their perception of the sensory feeling of the environment around them. Both questions will be measured on a six-point and six-point scale respectively. This will provide a more in detail understanding of the sensory and state of mind of thermal perception. Participants will be provided with a pen and will be asked to draw a line onto the scale regarding their answer. This will then be measured on a visual analogue scale, and be recorded in cm. The marker location will be taken as the uppermost and leftmost extent of the ink marking drawn by participants.
[Time Frame: through study completion, average 1 week]

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Portsmouth

Collaboratori

University of Southampton
Swansea University
Portsmouth Hospitals NHS Trust

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 aprile 2028

Completamento dello studio (Stimato)

1 aprile 2028

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 370139
  • UP/226698 (Altro numero di sovvenzione/finanziamento: Trinsic Collagen Ltd)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Fully anonymised research data (with all personal identifiers removed) may be made openly available in a public data repository after the study is completed. This anonymised dataset may be shared under a Creative Commons Attribution (CC BY) licence, meaning it can be freely used by others provided the original study is credited.

Dati/documenti di studio

  1. Protocollo di studio
    Identificatore informazioni: Protocol v1.2

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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