- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07560059
Acute Metabolic Outcomes in Diabetic Patients Hospitalized for COVID-19 (DMD-COV) (DMD-COV)
Acute Metabolic Outcomes of Diabetic Patients Hospitalized for COVID-19 in Algeria: A Prospective Cohort Study (DMD-COV)
Diabetes is a major risk factor for severe COVID-19 and poor clinical outcomes during hospitalization. However, little is known about the medium- and long-term metabolic consequences of COVID-19 in people with diabetes after hospital discharge.
The DMD-COV study is a prospective, multicenter observational cohort conducted in Algeria. Its aim is to evaluate the cardio-metabolic outcomes of adult patients with diabetes who were hospitalized for confirmed COVID-19 and survived the acute phase of the infection.
Adult patients with type 1 or type 2 diabetes will be included during hospitalization or within 30 days after hospital discharge. Participants will be followed for up to one year after discharge, with scheduled evaluations at baseline, 3 months, 6 months, and 12 months.
During follow-up, clinical, biological, and therapeutic data will be collected, including glycemic control (HbA1c), body weight, lipid profile, kidney function, and diabetes treatments. The main outcome is the proportion of patients achieving their individualized HbA1c target at 6 months and 12 months after hospitalization for COVID-19.
The results of this study will help to better understand the long-term metabolic impact of COVID-19 in people with diabetes and to improve post-COVID diabetes management.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
The DMD-COV study is a prospective, non-interventional, multicenter cohort study conducted in Algeria. The study aims to describe the cardio-metabolic outcomes of adult patients with diabetes following hospitalization for COVID-19.
Patients with type 1 or type 2 diabetes who were hospitalized for laboratory-confirmed COVID-19 (PCR, serology, or antigen test) will be included during hospitalization or within 30 days after discharge. The study does not interfere with routine clinical care, and all therapeutic decisions are made according to usual medical practice.
Approximately 200 patients will be enrolled across multiple university hospital centers. Participants will be followed for one year, with four scheduled visits: at baseline (inclusion), 3 months, 6 months, and 12 months after hospital discharge.
Data collected during the study include demographic characteristics, diabetes history, comorbidities, COVID-19 severity markers, duration of hospitalization, and treatments received during the acute phase, including corticosteroids and anticoagulants. At each follow-up visit, clinical parameters (weight, body mass index, waist circumference), glycemic control (HbA1c, fasting plasma glucose), lipid profile, renal function, and diabetes treatments will be recorded.
The primary outcome is glycemic control, assessed by the proportion of patients achieving their individualized HbA1c target at 6 months and 12 months after hospitalization. Secondary outcomes include changes in HbA1c over time, evolution of diabetes treatments, weight changes, lipid profile, renal function, and identification of factors associated with good glycemic control after COVID-19.
This study will provide valuable real-world data on the metabolic evolution of patients with diabetes after COVID-19 and may contribute to optimizing long-term follow-up strategies in this population.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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El Biar
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Algiers, El Biar, Argélia
- Djillali Belkhenchir Public Hospital (formerly Birtraria)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Age 18 years or older
- Diagnosis of type 1 or type 2 diabetes mellitus
- Hospitalization for laboratory-confirmed COVID-19
- Inclusion during hospitalization or within 30 days after hospital discharge
- Signed informed consent
Exclusion Criteria:
- Age under 18 years
- Absence of diabetes mellitus
- Refusal or inability to provide informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Diabetic patients hospitalized for COVID-19
Adult patients with type 1 or type 2 diabetes who were hospitalized for confirmed COVID-19 and followed prospectively after hospital discharge to assess cardio-metabolic outcomes over a one-year period.
|
This is a non-interventional observational study.
No experimental or therapeutic intervention is assigned as part of the study protocol.
All medical care and treatments are provided according to routine clinical practice.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Glycemic control after hospitalization for COVID-19
Prazo: 6 months and 12 months after hospital discharge
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Proportion of patients achieving their individualized HbA1c target according to international diabetes guidelines.
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6 months and 12 months after hospital discharge
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in HbA1c over follow-up
Prazo: Baseline, 3 months, 6 months, and 12 months
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Mean change in HbA1c from baseline to 3 months, 6 months, and 12 months after hospital discharge.
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Baseline, 3 months, 6 months, and 12 months
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Change in body weight and body mass index
Prazo: Baseline, 3 months, 6 months, and 12 months
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Change in body weight and body mass index (BMI) during follow-up.
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Baseline, 3 months, 6 months, and 12 months
|
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Evolution of diabetes treatment
Prazo: Up to 12 months after hospital discharge
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Changes in diabetes treatment regimen during follow-up, including insulin initiation or intensification and modification of oral or injectable antidiabetic therapies.
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Up to 12 months after hospital discharge
|
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Changes in lipid profile and renal function
Prazo: Baseline, 6 months, and 12 months
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Changes in lipid profile parameters and renal function during follow-up after COVID-19 hospitalization.
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Baseline, 6 months, and 12 months
|
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Factors associated with poor glycemic control after COVID-19
Prazo: Up to 12 months after hospital discharge
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Identification of clinical and therapeutic factors associated with failure to achieve individualized HbA1c targets after hospitalization for COVID-19.
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Up to 12 months after hospital discharge
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios pós-infecciosos
- Doenças do Sistema Endócrino
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Doenças Metabólicas
- Infecções do Trato Respiratório
- Infecções
- Infecções por vírus de RNA
- Doenças Virais
- Doenças Respiratórias
- Doenças pulmonares
- Distúrbios do Metabolismo da Glicose
- Pneumonia Viral
- Pneumonia
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Resistência a insulina
- Hiperinsulinismo
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- COVID-19
- Síndrome Pós-Aguda de COVID-19
- Síndrome metabólica
- Diabetes Mellitus
- Técnicas de investigação
- Métodos
- Observação
Outros números de identificação do estudo
- DMD-COV
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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