| Autor: |
Nguyet Minh Nguyen, Ho Quang Chanh, Dong Thi Hoai Tam, Nguyen Lam Vuong, Nguyen Thi Xuan Chau, Nguyen Van Vinh Chau, Nguyen Thanh Phong, Huynh Trung Trieu, Tai Luong Thi Hue, Tam Cao Thi, Trung Dinh The, Huynh Thi Le Duyen, Ninh Thi Thanh Van, Quyen Nguyen Than Ha, Laura Rivino, Peter Gallagher, Nick K. Jones, Ronald B. Geskus, Evelyne Kestelyn, Sophie Yacoub |
| Jazyk: |
angličtina |
| Rok vydání: |
2020 |
| Předmět: |
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| Zdroj: |
Wellcome Open Research, Vol 5 (2020) |
| Druh dokumentu: |
article |
| ISSN: |
2398-502X |
| DOI: |
10.12688/wellcomeopenres.16053.1 |
| Popis: |
Background: Dengue is a disease of major global importance. While most symptomatic infections are mild, a small proportion of patients progress to severe disease with risk of hypovolaemic shock, organ dysfunction and death. In the absence of effective antiviral or disease modifying drugs, clinical management is solely reliant on supportive measures. Obesity is a growing problem among young people in Vietnam and is increasingly recognised as an important risk factor for severe dengue, likely due to alterations in host immune and inflammatory pathways. Metformin, a widely used anti-hyperglycaemic agent with excellent safety profile, has demonstrated potential as a dengue therapeutic in vitro and in a retrospective observational study of adult dengue patients with type 2 diabetes. This study aims to assess the safety and tolerability of metformin treatment in overweight and obese dengue patients, and investigate its effects on several clinical, immunological and virological markers of disease severity. Methods: This open label trial of 120 obese/overweight dengue patients will be performed in two phases, with a metformin dose escalation if no safety concerns arise in phase one. The primary endpoint is identification of clinical and laboratory adverse events. Sixty overweight and obese dengue patients aged 10-30 years will be enrolled at the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam. Participants will complete a 5-day course of metformin therapy and be compared to a non-treated group of 60 age-matched overweight and obese dengue patients. Discussion: Previously observed antiviral and immunomodulatory effects of metformin make it a promising dengue therapeutic candidate in appropriately selected patients. This study will assess the safety and tolerability of adjunctive metformin in the management of overweight and obese young dengue patients, as well as its effects on markers of viral replication, endothelial dysfunction and host immune responses. Trial registration: ClinicalTrials.gov: NCT04377451 (May 6th 2020). |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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