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O estudo clínico NCT05329415 para Tuberculose, Diabetes mellitus está desconhecido. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Tuberculosis Drug Levels and Continuous Glucose Monitoring in Diabetic Patients 48
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O estudo clínico NCT05329415 é um estudo observacional para Tuberculose, Diabetes mellitus. Seu status atual é: desconhecido. O estudo começou em 1 de fevereiro de 2022 e pretende incluir 48 participantes. Coordenado por London North West Healthcare NHS Trust e deve ser concluído em 1 de maio de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 7 de junho de 2023.
Resumo
Diabetes significantly increases the risk of developing active tuberculosis (TB). Diabetic patients who do develop TB have worse treatment outcomes and overall mortality. TB also worsens blood glucose control in diabetics, the mechanism of which is not well understood. The incidence of type 2 diabetes is rising globally, and consequently diabetes and TB co-infection is increasingly common, and improving outcomes in t...Mostrar mais
Descrição detalhada
This study has been designed as a case control trial analysed via population pharmacokinetic modelling, with the hypothesis that overall exposure to TB medications will be lower in the diabetic than the non-diabetic group.
Non-Diabetic group (controls):
This group will be asked to take their TB medications as usual, and return at weeks 2 and 8 (timed to fit with routine appointments) and week 16. On these days, par...
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Tuberculosis Drug Levels and Continuous Glucose Monitoring in Diabetic Patients
Condições médicas
TuberculoseDiabetes mellitusOutros IDs do estudo
- v1 20.07.2021
Número NCT
Data de início (real)
2022-02-01
Última atualização postada
2023-06-07
Data de conclusão (estimada)
2024-05
Inscrição (estimada)
48
Tipo de estudo
Observacional
Status
Desconhecido
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Diabetic Group (Cases) 1. Subject aged 18 years of age or over
2. Written, informed consent obtained.
3. New diagnosis of tuberculosis and starting on anti-tuberculosis treatment
4. Known diagnosis of diabetes or a raised IFCC HbA1c level (\>= 48 mmol/mol) at the time of TB diagnosis | TB Drug Levels TB drug levels at 1-2 time points at weeks 2, 8 and 16 |
Non-Diabetic Group (Controls) 1. Subject aged 18 years of age or over
2. Written, informed consent obtained.
3. New diagnosis of tuberculosis and starting on anti-tuberculosis treatment
4. IFCC HbA1c level \< 48mmol/mol and no known diagnosis of diabetes | TB Drug Levels TB drug levels at 1-2 time points at weeks 2, 8 and 16 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Rifampicin/Isoniazid/Pyrazinamide Cmax 2 hours post-dose | To be measured via population pharmacokinetic modelling, with case group compared to control group. | 2, 8, 16 weeks as discussed above |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Antidiabetic medication Cmax at baseline and 2 hours post dose | To be measured via population pharmacokinetic modelling, with baseline compared to weeks 2, 8 and 16. | Baseline, 2, 8 and 16 weeks as discussed above |
Mean daily subcutaneous glucose measurement | Via CGM comparing baseline with week 16 | Baseline and 16 weeks for 10 days each |
Critérios de elegibilidade
Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
Cases:
- Subject aged 18 years of age or over
- Written, informed consent obtained.
- New diagnosis of tuberculosis and starting on anti-tuberculosis treatment
- Known diagnosis of diabetes or a raised IFCC HbA1c level (>= 48 mmol/mol) at the time of TB diagnosis
Controls:
- Subject aged 18 years of age or over
- Written, informed consent obtained.
- New diagnosis of tuberculosis and starting on anti-tuberculosis treatment
- IFCC HbA1c level < 48mmol/mol and no known diagnosis of diabetes
- Subject aged under 18 years
- Inability to give informed consent
London North West Healthcare NHS TrustSem dados de contato.
1 Locais do estudo em 1 países
London North West University NHS University Trust, London, HA1 3UJ, United Kingdom