drugset / Trial / NCT04377451
Metformin in Dengue With Obesity
Phase 1/2
Completed
120 enrolled
Oxford University Clinical Research Unit, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam · collab
Non-randomizedSequentialOpen-labelTreatment
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
Timeline
- Start
- 2020-07-27
- Primary completion
- 2023-06-01
- Completion
- 2023-08-01
Publications
- Background Do LM, Tran TK, Eriksson B, Petzold M, Nguyen CT, Ascher H. Preschool overweight and obesity in urban and rural Vietnam: differences in prevalence and associated factors. Glob Health Action. 2015 Oct 8;8:28615. doi: 10.3402/gha.v8.28615. eCollection 2015.
- Background Dieu HT, Dibley MJ, Sibbritt DW, Hanh TT. Trends in overweight and obesity in pre-school children in urban areas of Ho Chi Minh City, Vietnam, from 2002 to 2005. Public Health Nutr. 2009 May;12(5):702-9. doi: 10.1017/S1368980008003017. Epub 2008 Jul 29.
- Background Nguyen PV, Hong TK, Hoang T, Nguyen DT, Robert AR. High prevalence of overweight among adolescents in Ho Chi Minh City, Vietnam. BMC Public Health. 2013 Feb 15;13:141. doi: 10.1186/1471-2458-13-141.
- Background Zulkipli MS, Dahlui M, Jamil N, Peramalah D, Wai HVC, Bulgiba A, Rampal S. The association between obesity and dengue severity among pediatric patients: A systematic review and meta-analysis. PLoS Negl Trop Dis. 2018 Feb 7;12(2):e0006263. doi: 10.1371/journal.pntd.0006263. eCollection 2018 Feb.
- Background Harris K, Smith L. Safety and efficacy of metformin in patients with type 2 diabetes mellitus and chronic hepatitis C. Ann Pharmacother. 2013 Oct;47(10):1348-52. doi: 10.1177/1060028013503108.
- Background Doyle MA, Singer J, Lee T, Muir M, Cooper C. Improving treatment and liver fibrosis outcomes with metformin in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance: study protocol for a randomized controlled trial. Trials. 2016 Jul 20;17(1):331. doi: 10.1186/s13063-016-1454-6.
- Background 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.
- Background Khan IM, Malik BR, Randhawa FA, Butt NF, Malik U, Hamid S. Comparison of metformin and pioglitazone in achieving sustained virological response in chronic hepatitis C patients with insulin resistance: A quasi-experimental study. J Pak Med Assoc. 2017 Dec;67(12):1848-1852.
- Background Padmapriyadarsini C, Bhavani PK, Natrajan M, Ponnuraja C, Kumar H, Gomathy SN, Guleria R, Jawahar SM, Singh M, Balganesh T, Swaminathan S. Evaluation of metformin in combination with rifampicin containing antituberculosis therapy in patients with new, smear-positive pulmonary tuberculosis (METRIF): study protocol for a randomised clinical trial. BMJ Open. 2019 Mar 1;9(3):e024363. doi: 10.1136/bmjopen-2018-024363.
- Background Kay JP, Alemzadeh R, Langley G, D'Angelo L, Smith P, Holshouser S. Beneficial effects of metformin in normoglycemic morbidly obese adolescents. Metabolism. 2001 Dec;50(12):1457-61. doi: 10.1053/meta.2001.28078.
- Background Pastor-Villaescusa B, Canete MD, Villarraso-Caballero J, et al. Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. Pediatrics. 2017;140 (1):e20164285. Pediatrics. 2017 Nov;140(5):e20172555. doi: 10.1542/peds.2017-2555. No abstract available.
- Background Soto-Acosta R, Bautista-Carbajal P, Cervantes-Salazar M, Angel-Ambrocio AH, Del Angel RM. DENV up-regulates the HMG-CoA reductase activity through the impairment of AMPK phosphorylation: A potential antiviral target. PLoS Pathog. 2017 Apr 6;13(4):e1006257. doi: 10.1371/journal.ppat.1006257. eCollection 2017 Apr.
- Minh Nguyen N, Thi Hoai Tam D, Quang Chanh H, Trung Trieu H, Thi Xuan Chau N, Thanh Van N, Thanh Phong N, Thi Tam C, Thi Hong Lan N, Thi Hue Tai L, Thi Cam Huong N, Thi Ngoc Thuan L, Van Hao N, Tu Qui P, Thi Dong Vien T, Thi Hai Men P, Thi Thuy Hoa H, Vinh Tho P, Thi Le Duyen H, Tran Thuy V, Dang Trong T, Tan Thanh Kieu N, McBride A, Kestelyn E, Geskus RB, Lam Vuong N, Yacoub S. Safety and tolerability of metformin in overweight and obese patients with dengue: An open-label clinical trial (MeDO). PLoS Negl Trop Dis. 2025 Jul 1;19(7):e0013281. doi: 10.1371/journal.pntd.0013281. eCollection 2025 Jul.
- Nguyen NM, Chanh HQ, Tam DTH, Vuong NL, Chau NTX, Chau NVV, Phong NT, Trieu HT, Luong Thi Hue T, Cao Thi T, Dinh The T, Duyen HTL, Van NTT, Nguyen Than Ha Q, Rivino L, Gallagher P, Jones NK, Geskus RB, Kestelyn E, Yacoub S. Metformin as adjunctive therapy for dengue in overweight and obese patients: a protocol for an open-label clinical trial (MeDO). Wellcome Open Res. 2021 Feb 8;5:160. doi: 10.12688/wellcomeopenres.16053.2. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | — |
| Subject | Metformin | Small molecule | 850 mg | — |
| Subject | Metformin | Small molecule | 1000 mg | — |
| Subject | Metformin | Small molecule | 1500 mg | — |