Fructose for Acute Ischemic Stroke
Summary
This is a single-center, prospective, randomized, open-label, blinded-endpoint exploratory clinical study enrolling 46 patients with acute ischemic stroke. All eligible patients have symptom onset within 4.5 hours, meet intravenous thrombolysis indications, and receive standard thrombolysis and routine stroke treatment. Participants are randomly assigned to two groups: the intervention group receives early intravenous infusion of 10% fructose injection plus standard treatment, while the control group receives only standard treatment without fructose. The study mainly evaluates changes in neurological function via NIHSS scores within 7 days after thrombolysis, assesses cerebral infarct lesion volume and brain edema using multimodal MRI including DWI, T2WI and MRS, detects cerebral neuronal metabolic markers, and conducts 1-month follow-up of neurological function by NIHSS score as well as functional prognosis using the mRS score. The research also comprehensively monitors adverse events and safety indicators to explore the clinical efficacy, neuronal metabolic regulation effect and safety of early fructose injection combined with intravenous thrombolysis in acute ischemic stroke patients, aiming to provide clinical evidence for early neuroprotective intervention.
Timeline
- Start
- 2026-06-05
- Primary completion
- 2026-08
- Completion
- 2026-08
Publications
- Background Zhang D, Feng Y, Pan H, Xuan Z, Yan S, Mao Y, Xiao X, Huang X, Zhang H, Zhou F, Chen B, Chen X, Liu H, Yan X, Liang H, Cui W. 9-Methylfascaplysin exerts anti-ischemic stroke neuroprotective effects via the inhibition of neuroinflammation and oxidative stress in rats. Int Immunopharmacol. 2021 Aug;97:107656. doi: 10.1016/j.intimp.2021.107656. Epub 2021 Apr 23.
- Background Tian Y, Su Y, Ye Q, Chen L, Yuan F, Wang Z. Silencing of TXNIP Alleviated Oxidative Stress Injury by Regulating MAPK-Nrf2 Axis in Ischemic Stroke. Neurochem Res. 2020 Feb;45(2):428-436. doi: 10.1007/s11064-019-02933-y. Epub 2019 Dec 19.
- Background Marek G, Pannu V, Shanmugham P, Pancione B, Mascia D, Crosson S, Ishimoto T, Sautin YY. Adiponectin resistance and proinflammatory changes in the visceral adipose tissue induced by fructose consumption via ketohexokinase-dependent pathway. Diabetes. 2015 Feb;64(2):508-18. doi: 10.2337/db14-0411. Epub 2014 Sep 3.
- Background Kim YN, Jung HY, Eum WS, Kim DW, Shin MJ, Ahn EH, Kim SJ, Lee CH, Yong JI, Ryu EJ, Park J, Choi JH, Hwang IK, Choi SY. Neuroprotective effects of PEP-1-carbonyl reductase 1 against oxidative-stress-induced ischemic neuronal cell damage. Free Radic Biol Med. 2014 Apr;69:181-96. doi: 10.1016/j.freeradbiomed.2014.01.006. Epub 2014 Jan 17.
- Background Hayasaki T, Ishimoto T, Doke T, Hirayama A, Soga T, Furuhashi K, Kato N, Kosugi T, Tsuboi N, Lanaspa MA, Johnson RJ, Maruyama S, Kadomatsu K. Fructose increases the activity of sodium hydrogen exchanger in renal proximal tubules that is dependent on ketohexokinase. J Nutr Biochem. 2019 Sep;71:54-62. doi: 10.1016/j.jnutbio.2019.05.017. Epub 2019 Jun 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fructose | Small molecule | 10 % | Intravenous |
| Subject | Fructose | Small molecule | 250 ml | Intravenous |