Metformin as Adjunctive Therapy in Overweight and Obese Patients With Dengue: an Open-label Safety and Tolerability Trial

56DX

This study aims to investigate the effect of metformin as host-directed therapy in obese/overweight patients with dengue Primary Objective To evaluate the safety and tolerability of metformin in obese/overweight young adults and children with dengue Secondary Objectives * To assess the effect of metformin therapy in obese/overweight patients with dengue on physiological, clinical and virological parameters * To assess the immunomodulation effects of metformin therapy in obese/overweight patients with dengue * To assess difference in gene expression between treatment group compared to non-treatment population

2020-07-27

2023-06-01

2023-08-01

Completed

Early phase I

120

Inclusion Criteria: * ≥ 10 years to ≤ 30 years of age, * Clinical diagnosis of dengue (based on WHO 2009 Dengue: Guidelines for Diagnosis, Treatment, Prevention and Control/Vietnam Ministry of Health 2019: Guidelines for Dengue Diagnosis, treatment and prevention) * Positive NS1 rapid test * ≤ 3 days (≤ 72 hours) of fever * BMI \> 25 Kg/m2 (or BMI-for-age \> 1 SD); * Written informed consent or assent to participate in the study * Agree to come back for follow up visit around day 21-28 of illness (maximum 1 month) Exclusion Criteria: * In all female patients: Pregnancy Localizing features suggesting an alternative diagnosis, e.g. pneumonia, otitis etc. * History of hypersensitivity to metformin * Severe infection, including: (1) severe dengue (dengue shock syndrome, severe haemorrhage, severe organ impairment) (2) central nervous system infection, or (3) septicaemia etc... * Baseline lactate level \> 2.0 mmol/L * Baseline glucose level \< 3.9 mmol/L OR \< 70 mg/dL * Already taking metformin or any other regular hypoglycaemic agents, eg. insulin * Significant diarrhoea and/or vomiting (\> 3 episodes in 24 hours) * Have acute or chronic renal impairment (baseline GFR \< 30ml/min) * Liver impairment (baseline AST and ALT \> 250 U/L) * Being treated for heart failure or have had a recent heart attack (in the last year) * Taking any drug with significant interaction with metformin * The study physician judges that the patient is unlikely to attend follow up visit at around 3-4 weeks after fever onset - e.g. due to long travelling distance from the clinic

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2023-08-31