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Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in College Students (RCSOGRABCICS)

8 de setembro de 2026 atualizado por: He Eye Hospital

A Retrospective Study of Individual Glycemic Response Based on CGM Wearable Devices in Weight and Body Composition Management Among College Students

This retrospective study evaluates the real-world effect of individualized glycemic response-guided dietary management, based on continuous glucose monitoring (CGM), on weight and body composition in overweight and obese university students. All data for this analysis were retrospectively retrieved from the archived records of a randomized controlled trial conducted at He University, in which 60 students (body mass index [BMI] ≥ 24 kg/m² or elevated body fat percentage) had worn CGM sensors for 4 weeks. The archived records show that the exposed group (n = 30) had received individualized dietary guidance generated from their own glucose responses, including structured CGM reports, meal composition and eating-order advice, and standardized feedback, whereas the non-exposed group (n = 30) had worn CGM without receiving any dietary guidance. One non-exposed participant was excluded from this retrospective analysis for missing primary outcome data, leaving 59 participants for analysis. The archived dataset contains body composition (weight, body mass index [BMI], body fat mass, percent body fat, skeletal muscle mass, visceral fat level) and eating behavior records at Day 0, Day 28, and Day 90. This analysis examines whether the 4-week intervention produced sustained, fat-mass-driven improvements in body composition and whether changes in eating behavior mediated these effects.

Visão geral do estudo

Status

Status

Indica o status de recrutamento atual ou o status de acesso expandido.
Concluído

Condições

Condições

A doença, distúrbio, síndrome, doença ou lesão que está sendo estudada. Em ClinicalTrials.gov, as condições também podem incluir outros problemas relacionados à saúde, como expectativa de vida, qualidade de vida e riscos à saúde.

Descrição detalhada

Background: continuous glucose monitoring (CGM) technology is expanding from diabetes care to weight management in healthy populations. Individualized glycemic response-guided dietary management may improve weight loss efficiency, but whether a brief 4-week intervention produces sustained body composition benefits remains unclear.

Design: This is a retrospective analysis of data collected in a two-arm, parallel-group randomized controlled trial conducted at He University, Shenyang, China. No new intervention was administered and no new measurements were performed in the present study; all data were retrospectively extracted from existing archived records. Participants were classified into two cohorts according to the exposure documented in the archived data of the parent trial. The archived records document that 60 overweight or obese university students (aged 18-25 years) had been randomized 1:1 by a random number table in the parent trial, and that both groups had worn the GX-01S continuous glucose monitoring system for 4 weeks (28 days). The archived records show that the exposed group had received an individualized glycemic response-guided dietary intervention: weeks 1-2 served as a dietary behavior observation period (CGM glucose profiles and electronic food diaries), and weeks 3-4 comprised the individualized intervention, including structured CGM reports (glucose trend graphs, traffic-light food lists, individually glucose-sensitive time windows), dietary guidance on meal composition and eating order, and standardized researcher feedback. The archived records show that the non-exposed group had worn CGM without dietary guidance; CGM data were visible during weeks 1-2 and blinded during weeks 3-4.

Assessments: The archived dataset contains body composition measurements recorded with the InBody 120 bioelectrical impedance analyzer at Day 0 (baseline), Day 28 (end of the 4-week period), and Day 90 (follow-up), together with Dutch Eating Behavior Questionnaire (DEBQ) records at the same three timepoints. All values were retrospectively extracted; no additional measurement was performed for this study.

Outcomes: Primary outcomes of the parent study were time above range (TAR) change and body weight change, both derived from the archived records. This analysis focuses on body composition outcomes: weight, body mass index (BMI), percent body fat, body fat mass, skeletal muscle mass, visceral fat level, and segmental body fat across five body compartments, together with exploratory mediation analyses testing whether DEBQ subscale changes (restrained, emotional, and external eating) mediated the intervention effect.

Ethics: The parent study was approved by the Institutional Ethics Committee of He University, and all participants provided written informed consent. For this retrospective analysis of anonymized data, the ethics committee approved a waiver of renewed informed consent.

Tipo de estudo

Tipo de estudo

Descreve a natureza de um estudo clínico. Os tipos de estudo incluem estudos intervencionais (também chamados de ensaios clínicos), estudos observacionais (incluindo registros de pacientes) e acesso expandido.
Observacional

Inscrição (Real)

Inscrição

O número de participantes em um estudo clínico. A inscrição "antecipada" é o número alvo de participantes que os pesquisadores precisam para o estudo.
59

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • He University, Shenyang, Liaoning, China

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Critérios de elegibilidade

Os principais requisitos que as pessoas que desejam participar de um estudo clínico devem atender ou as características que devem ter. Os critérios de elegibilidade consistem em critérios de inclusão (que são necessários para que uma pessoa participe do estudo) e critérios de exclusão (que impedem uma pessoa de participar). Tipos de critérios de elegibilidade incluem se um estudo aceita voluntários saudáveis, tem requisitos de idade ou faixa etária ou é limitado por sexo.

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Overweight and obese university students (aged 18-25 years) at He University, Shenyang, Liaoning, China, whose records are contained in the archived dataset of a randomized controlled trial of a 4-week continuous glucose monitoring (CGM)-guided personalized dietary intervention. Participants had a body mass index (BMI) ≥ 24 kg/m² or elevated body fat percentage (≥ 25% in men, ≥ 32% in women) and self-reported at least two unhealthy eating behaviors. Of the 60 participants enrolled in the parent trial (30 per group), 59 were included in this retrospective analysis (30 exposed, 29 non-exposed); one non-exposed participant was excluded for missing primary outcome data. All participants were free of diabetes, prediabetes, and other exclusion conditions defined in the study protocol.

Descrição

Inclusion Criteria:

  • University students aged 18 to 25 years
  • Body mass index (BMI) ≥ 24.0 kg/m², or body fat percentage ≥ 25% (male) / ≥ 32% (female)
  • Self-reported presence of at least two unhealthy eating behaviors
  • Written informed consent

Exclusion Criteria:• Obesity due to endocrine diseases (e.g., Cushing's syndrome, hypothyroidism, hypothalamic obesity) or genetic syndromes

  • Polycystic ovary syndrome (PCOS)
  • Weight gain or glycemic abnormality induced by medications (e.g., glucocorticoids, antipsychotics, insulin secretagogues)
  • Diagnosed diabetes (type 1 or type 2) or prediabetes (fasting glucose ≥ 6.1 mmol/L or glycated hemoglobin (HbA1c)≥ 5.7%)
  • Diagnosed dyslipidemia with lipid-lowering medication
  • High risk of eating disorders identified by the Eating Disorder Diagnostic Scale (EDDS)
  • Severe psychiatric disorders or psychotropic medication use
  • Pregnancy, lactation, or planned pregnancy within 6 months
  • Allergy to CGM adhesive or hydrogel, or active skin disease affecting sensor wear
  • Professional athletes (high-intensity physical activity ≥ 5 times/week, ≥ 60 min/session)
  • Weight change > 5% of initial body weight within the past 3 months
  • Participation in other commercial or clinical weight-loss programs

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte

Grupo / Coorte

Um grupo ou subgrupo de participantes em um estudo observacional que é avaliado quanto a resultados biomédicos ou de saúde.
Exposed (n=30)
Participants whose archived records from the parent trial indicate that they had received a 4-week individualized glycemic response-guided dietary intervention based on continuous glucose monitoring (CGM) data: dietary behavior observation during weeks 1-2, followed by structured CGM reports, dietary guidance on meal composition and eating order, and standardized researcher feedback during weeks 3-4.
Non-exposed (n=29)
Participants whose archived records from the parent trial indicate that they had worn the CGM system for 4 weeks without receiving dietary guidance or feedback. CGM data were visible during weeks 1-2 and blinded during weeks 3-4. Participants maintained their usual diet and lifestyle. One of the 30 non-exposed participants enrolled in the parent trial was excluded from this retrospective analysis for missing primary outcome data.

O que o estudo está medindo?

Medidas de resultados primários

Medidas de resultados primários

No protocolo de um estudo clínico, a medida de resultado planejada que é a mais importante para avaliar o efeito de uma intervenção/tratamento. A maioria dos estudos clínicos tem uma medida de desfecho primário, mas alguns têm mais de uma.
Medida de resultado
Descrição da medida
Prazo
Time above range (TAR)
Prazo: Data recorded at baseline, Day 14, and Day 28
Change in the percentage of time above the target glucose range recorded in the archived CGM dataset. Unit of Measure: Percent of time (%).
Data recorded at baseline, Day 14, and Day 28
Body weight
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body weight recorded in the archived InBody 120 dataset. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90

Medidas de resultados secundários

Medidas de resultados secundários

No protocolo de um estudo clínico, uma medida de resultado planejada que não é tão importante quanto a medida de resultado primária para avaliar o efeito de uma intervenção, mas ainda é de interesse. A maioria dos estudos clínicos tem mais de uma medida de desfecho secundário.
Medida de resultado
Descrição da medida
Prazo
Body fat mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in total body fat mass derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90
Body mass index (BMI)
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body mass index, calculated as body weight in kilograms divided by the square of body height in meters, derived from the archived InBody 120 records. Unit of Measure: Kilogram per square meter (kg/m²).
Data recorded at Day 0, Day 28, and Day 90
Percent body fat
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body fat percentage, calculated as body fat mass divided by total body weight, derived from the archived InBody 120 records. Unit of Measure: Percent (%).
Data recorded at Day 0, Day 28, and Day 90
Skeletal muscle mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in skeletal muscle mass derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90
Visceral fat level
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in visceral fat level derived from the archived InBody 120 records. Scale range: minimum 1, maximum 20; higher levels indicate greater visceral adiposity (worse). Unit of Measure: InBody visceral fat level (unitless scale, 1-20).
Data recorded at Day 0, Day 28, and Day 90
Waist circumference
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in waist circumference derived from the archived anthropometric records. Unit of Measure: Centimeter (cm).
Data recorded at Day 0, Day 28, and Day 90
Hip circumference
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in hip circumference derived from the archived anthropometric records. Unit of Measure: Centimeter (cm).
Data recorded at Day 0, Day 28, and Day 90
Waist-hip ratio
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in waist-hip ratio, calculated as waist circumference divided by hip circumference, derived from the archived anthropometric records. Unit of Measure: Ratio (unitless).
Data recorded at Day 0, Day 28, and Day 90
Time in range (TIR)
Prazo: Data recorded from Day 0 to Day 28
Change in the percentage of time within the target glucose range derived from the archived CGM records. Unit of Measure: Percent of time (%).
Data recorded from Day 0 to Day 28
Average glucose (AG)
Prazo: Data recorded from Day 0 to Day 28
Change in average glucose derived from the archived CGM records. Unit of Measure: Millimole per liter (mmol/L).
Data recorded from Day 0 to Day 28
Coefficient of variation (CV)
Prazo: Data recorded from Day 0 to Day 28
Change in the coefficient of variation of glucose derived from the archived CGM records. Unit of Measure: Percent (%).
Data recorded from Day 0 to Day 28
DEBQ restrained eating subscale
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the restrained eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records. Higher scores indicate a greater tendency toward restrained eating; in this study, increases in this score were considered favorable (better dietary self-regulation). Unit of Measure: Subscale score (1-5).
Data recorded at Day 0, Day 28, and Day 90
DEBQ emotional eating subscale
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the emotional eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records. Higher scores indicate a greater tendency to eat in response to negative emotions; in this weight-management context, higher scores are considered unfavorable (worse outcome). Unit of Measure: Subscale score (1-5).
Data recorded at Day 0, Day 28, and Day 90
DEBQ external eating subscale
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the external eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records. Higher scores indicate a greater tendency to eat in response to external food cues; in this weight-management context, higher scores are considered unfavorable (worse outcome). Unit of Measure: Subscale score (1-5).
Data recorded at Day 0, Day 28, and Day 90
Eating Disorder Diagnostic Scale (EDDS) score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the Eating Disorder Diagnostic Scale (EDDS) symptom composite score derived from the archived records. Scale range: minimum 0, maximum 227; higher scores indicate more severe eating disorder symptoms (worse outcome). Unit of Measure: Score (0-227).
Data recorded at Day 0, Day 28, and Day 90
Pittsburgh Sleep Quality Index (PSQI) score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the Pittsburgh Sleep Quality Index (PSQI) global score derived from the archived records. Scale range: minimum 0, maximum 21; higher scores indicate poorer sleep quality (worse outcome). Unit of Measure: Score (0-21).
Data recorded at Day 0, Day 28, and Day 90
Perceived Stress Scale (PSS-10) score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the Perceived Stress Scale (PSS-10) total score derived from the archived records. Scale range: minimum 0, maximum 40; higher scores indicate greater perceived stress (worse outcome). Unit of Measure: Score (0-40).
Data recorded at Day 0, Day 28, and Day 90
Traditional Chinese Medicine (TCM) balanced constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the balanced constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate a more balanced constitution (better outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM qi-deficiency constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the qi-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM yang-deficiency constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the yang-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM yin-deficiency constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the yin-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM phlegm-dampness constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the phlegm-dampness constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM damp-heat constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the damp-heat constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM blood-stasis constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the blood-stasis constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM qi-stagnation constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the qi-stagnation constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
TCM special diathesis constitution score
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in the special diathesis constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records. Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome). Unit of Measure: Score (0-100).
Data recorded at Day 0, Day 28, and Day 90
Right arm fat mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body fat mass of the right arm derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90
Left arm fat mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body fat mass of the left arm derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90
Trunk fat mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body fat mass of the trunk derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90
Right leg fat mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body fat mass of the right leg derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90
Left leg fat mass
Prazo: Data recorded at Day 0, Day 28, and Day 90
Change in body fat mass of the left leg derived from the archived InBody 120 records. Unit of Measure: Kilogram (kg).
Data recorded at Day 0, Day 28, and Day 90

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Patrocinador

A organização ou pessoa que inicia o estudo e que tem autoridade e controle sobre o estudo.
He Eye Hospital

Investigadores

Investigadores

Um pesquisador envolvido em um estudo clínico. Os termos relacionados incluem investigador principal do centro, subinvestigador do centro, coordenador do estudo, diretor do estudo e investigador principal do estudo.
  • Investigador principal: Jun Li, MD, He University, Shenyang, Liaoning, China

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

Início do estudo

A data real em que o primeiro participante foi inscrito em um estudo clínico. A data de início do estudo "antecipada" é a data que os pesquisadores acham que será a data de início do estudo.
27 de junho de 2026

Conclusão Primária (Real)

Conclusão Primária

A data em que o último participante de um estudo clínico foi examinado ou recebeu uma intervenção para coletar dados finais para a medida de resultado primário. Se o estudo clínico terminou de acordo com o protocolo ou foi encerrado, não afeta esta data. Para estudos clínicos com mais de uma medida de resultado primário com diferentes datas de conclusão, este termo refere-se à data em que a coleta de dados é concluída para todas as medidas de resultado primário. A data de conclusão primária "antecipada" é a data que os pesquisadores acham que será a data de conclusão primária do estudo.
30 de julho de 2026

Conclusão do estudo (Real)

Conclusão do estudo

A data em que o último participante de um estudo clínico foi examinado ou recebeu uma intervenção/tratamento para coletar dados finais para as medidas de resultado primário, medidas de resultado secundário e eventos adversos (ou seja, a última visita do último participante). A data "prevista" de conclusão do estudo é a data que os pesquisadores acham que será a data de conclusão do estudo.
15 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez

A data em que o patrocinador ou investigador do estudo enviou pela primeira vez um registro do estudo para ClinicalTrials.gov. Normalmente, há um atraso de alguns dias entre a primeira data de envio e a disponibilidade do registro em ClinicalTrials.gov (a primeira data publicada).
25 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

Enviado pela primeira vez que atendeu aos critérios de CQ

A data em que o patrocinador ou investigador do estudo envia pela primeira vez um registro do estudo que seja consistente com os critérios de revisão do controle de qualidade (QC) da National Library of Medicine (NLM). O patrocinador ou investigador pode precisar revisar e enviar um registro de estudo uma ou mais vezes antes que os critérios de revisão de QC do NLM sejam atendidos. É responsabilidade do patrocinador ou investigador garantir que o registro do estudo seja consistente com os critérios de revisão do NLM QC.
8 de setembro de 2026

Primeira postagem (Real)

Primeira postagem

A data em que o registro do estudo foi disponibilizado pela primeira vez em ClinicalTrials.gov após a conclusão da revisão do controle de qualidade (QC) da National Library of Medicine (NLM). Normalmente, há um atraso de alguns dias entre a data em que o patrocinador ou investigador do estudo enviou o registro do estudo e a primeira data publicada.
14 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última Atualização Postada

A data mais recente em que as alterações em um registro de estudo foram disponibilizadas em ClinicalTrials.gov. Pode haver um atraso entre o momento em que as alterações foram enviadas ao ClinicalTrials.gov pelo patrocinador ou investigador do estudo (a última data de envio de atualização) e a data de publicação da última atualização.
14 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última atualização enviada que atendeu aos critérios de controle de qualidade

A data mais recente em que o patrocinador ou investigador do estudo enviou alterações em um registro do estudo que são consistentes com os critérios de revisão do controle de qualidade (QC) da National Library of Medicine (NLM). É responsabilidade do patrocinador ou investigador garantir que o registro do estudo seja consistente com os critérios de revisão do NLM QC.
8 de setembro de 2026

Última verificação

Última verificação

A data mais recente em que o patrocinador ou investigador do estudo confirmou as informações sobre um estudo clínico no ClinicalTrials.gov como precisas e atuais. Se um estudo com status de recrutamento de recrutamento; ainda não está recrutando; ou ativo, não recrutando não foi confirmado nos últimos 2 anos, o status de recrutamento do estudo é mostrado como desconhecido.
1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Outros números de identificação do estudo

Identificadores ou números de identificação diferentes do número NCT que são atribuídos a um estudo clínico pelo patrocinador, financiadores ou outros do estudo. Esses números podem incluir identificadores exclusivos de outros registros de ensaios e números de concessão do National Institutes of Health.
  • IRB(2026)K005.01

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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