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Metformin in Dengue With Obesity

NCT04377451 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-31

No results posted yet for this study

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

Conditions

Interventions

DRUG

Metformin

The trial will be conducted in two phases, with a dose escalation of metformin. Metformin dosing will begin at 500mg (children) and 850mg (adults) once daily for 5 days in cohort 1. Cohort 2 will be received weight-based doses; 5 days of 1000mg (500mg twice daily) for those weighing \<60kg and 5 days of 1500mg (1000mg mane, 500mg nocte) for those weighing ≥60kg

Sponsors & Collaborators

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Sophie Yacoub, PhD. MD · University of Oxford, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2023-06-01
Completion
2023-08-01

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04377451 on ClinicalTrials.gov