Status:
COMPLETED
Metformin in Dengue With Obesity
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Conditions:
Dengue
Viral Infection
Eligibility:
All Genders
10-30 years
Phase:
PHASE1
PHASE2
Brief 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 obe...
Detailed Description
This is an open-label safety and tolerability study investigating the effects of five days of metformin treatment. The metformin therapy will be given to eligible participants admitted to the Hospital...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04377451
Start Date
July 27 2020
End Date
August 1 2023
Last Update
August 31 2023
Active Locations (1)
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1
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam