Obesity Clinical Trial
— MeDOOfficial title:
Metformin as Adjunctive Therapy in Overweight and Obese Patients With Dengue: an Open-label Safety and Tolerability Trial
Verified date | August 2023 |
Source | Oxford University Clinical Research Unit, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 120 |
Est. completion date | August 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 30 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | Hospital for Tropical Diseases | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Oxford University Clinical Research Unit, Vietnam | Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam |
Vietnam,
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Htun HL, Yeo TW, Tam CC, Pang J, Leo YS, Lye DC. Metformin Use and Severe Dengue in Diabetic Adults. Sci Rep. 2018 Feb 20;8(1):3344. doi: 10.1038/s41598-018-21612-6. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events | Number of severe clinical symptoms and signs, including severe diarrhoea (defined as >5 episodes watery stool/day), severe vomiting (>=3 episodes separated by 15 minutes/24 hours), severe abdominal pain and laboratory markers of severity including -Hypoglycaemia defined as glucose <3.9 mmol/l, Hyperlactatemia (lactate >3 mmol/l), ALT/AST >400 U/l | Up to 30 days after enrollment | |
Secondary | Fever clearance time | Time to temperature <37.5 for 2 consecutive days | Up to 7 days after enrollment | |
Secondary | Platelet nadir | Lowest platelet count recorded during admission | Up to 7 days after enrollment | |
Secondary | Percentage increase in hematocrit from baseline | Percentage increase will be calculated from peak result to baseline (baseline is follow-up time-point) | Up to 30 days after enrollment | |
Secondary | Percentage change in endothelial and lipid-inflammatory parameters | Percentage change in parameters such as: VCAM1, ICAM1, leptin, adiponectin, LDL, AMPK levels will be calculated from peak result to baseline (follow-up time-point) | Up to 30 days after enrollment | |
Secondary | Changes in virological parameters | Area under the curve (AUC) of the serial measurements during days 3 - 6 (log10-transformed), time from enrollment to the first undetectable viraemia, or the first negative NS1 measurement will be compared | Up to 7 days after enrollment | |
Secondary | Changes in number of immune cells | Phenotyping CD8/4+T cell and NK cell and T cell exhaustion markers will be assessed | Up to 30 days after enrollment |
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