Metformin in Dengue With Obesity

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Clinical Research Unit, Vietnam
• Collaborator: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
• Treatments: Metformin

Criteria

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