Fructose for Acute Ischemic Stroke

NCT07626541 | Recruiting Phase 2 DMC

• 1 other identifier: AIS-FRUCTOSE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Fructose; Intravenous thrombolysis; Neuroprotection; NIHSS; Brain magnetic resonance spectroscopy; Cerebral energy metabolism

Outcome Measures

Primary Outcomes (1)

• 7-day change in National Institutes of Health Stroke Scale (NIHSS) score

  Absolute change in NIHSS score, calculated as follow-up score minus pre-intravenous thrombolysis (pre-IVT) baseline score, assessed at 7 days after intravenous thrombolysis (IVT). The full scale is the National Institutes of Health Stroke Scale; total score ranges from 0 to 42, and higher scores indicate more severe neurological deficits.

  Baseline to 7 days after thrombolysis

Secondary Outcomes (7)

• Levels of N-acetylaspartate (NAA) detected by proton magnetic resonance spectroscopy (¹H-MRS)

  Pre-IVT baseline to 24 hours post-IVT (±2 hours)

• Levels of choline (Cho) detected by proton magnetic resonance spectroscopy (¹H-MRS)

  Time Frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)

• Levels of creatine (Cr) detected by proton magnetic resonance spectroscopy (¹H-MRS)

  Pre-IVT baseline to 24 hours post-IVT (±2 hours)

• NAA/Cr ratio derived from ¹H-MRS

  Pre-IVT baseline to 24 hours post-IVT (±2 hours)

• Cho/Cr ratio derived from ¹H-MRS

  Time Frame: Pre-IVT baseline to 24 hours post-IVT (±2 hours)

Study Arms (2)

Fructose Injection plus Standard Thrombolysis Treatment

EXPERIMENTAL

Patients receive early intravenous infusion of 250 mL 10% fructose injection immediately after admission, followed by standard intravenous thrombolysis and routine standardized medical treatment for acute ischemic stroke. Unified blood pressure and blood glucose management are performed in all participants, and antiplatelet therapy is initiated 24 hours after thrombolysis.

Drug: 10% Fructose Injection

Standard Thrombolysis Alone Without Fructose

NO INTERVENTION

Patients receive only standard intravenous thrombolysis and routine standardized medical treatment for acute ischemic stroke without additional fructose injection. All participants receive the same unified blood pressure, blood glucose control and antiplatelet therapy regimen as the intervention group.

Interventions

10% Fructose Injection DRUG

Single intravenous infusion of 250 mL 10% fructose injection administered as early as possible within the ischemic stage, combined with standard intravenous thrombolysis and standardized basic treatment for acute ischemic stroke. Unified blood pressure and blood glucose management are implemented, and antiplatelet therapy is started 24 hours after thrombolysis.

Fructose Injection plus Standard Thrombolysis Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 85 years, male and female are both eligible.
• Clinical diagnosis of acute ischemic stroke meeting the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke.
• Time from stroke onset to hospital admission ≤ 4.5 hours, with new ischemic lesions confirmed by emergency multimodal cranial MRI (DWI/T2WI).
• Meeting the indications for intravenous thrombolysis, without absolute contraindications to thrombolysis, and planned to receive standard intravenous thrombolysis.
• Relatively stable vital signs, able to complete baseline and follow-up cranial MRI examinations including DWI, T2WI and ¹H-MRS, as well as NIHSS and mRS scale assessments.
• The patient or legal representative voluntarily participates in the study and signs written informed consent.

You may not qualify if:

• History of fructose intolerance, abnormal fructose metabolism or hereditary fructose metabolic disorders.
• History of diabetes mellitus or random blood glucose \> 11.1 mmol/L.
• Evidence of intracranial hemorrhage on CT scan, symptomatic intracranial hemorrhage, or clinical suspicion of subarachnoid hemorrhage.
• Requiring or intending to continue using restricted medications that may interfere with study safety and implementation.
• Unable to complete cranial MRI examination due to implanted metal materials, claustrophobia or other reasons.
• Any other conditions judged by the investigator to be inappropriate for enrollment.
• Presence of hemorrhagic diathesis, including but not limited to:
• Known hereditary bleeding tendency or severe bleeding disease within the past 6 months;
• Received heparin within 48 hours before enrollment with aPTT exceeding the upper limit of laboratory reference range;
• Current use of vitamin K-dependent oral anticoagulants with INR \> 1.7 or PT \> 15 s, or current use of novel oral anticoagulants with prolonged aPTT/PT above laboratory upper limit;
• Platelet count \< 100,000/mm³ at screening;
• History of central nervous system diseases such as tumor, aneurysm, intracranial or spinal surgery;
• Received traumatic closed-chest cardiac massage, obstetric delivery or non-compressible vascular puncture within the past 10 days;
• Suspected intracranial hemorrhage or aneurysmal subarachnoid hemorrhage;
• Tumors with increased bleeding risk;

Sponsors & Collaborators

• Ji Xunming,MD,PhD: lead

Study Sites (1)

Xuzhou Medical University Affiliated Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 33895476 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.

  PMID: 31858374 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.

  PMID: 25187370 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.

  PMID: 24440593 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.

  PMID: 31276916 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Fructose

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Central Study Contacts

Yu Feng professor, PhD

CONTACT

0516-83353238; xyfysjnkfy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label trial with blinded endpoint assessment (PROBE design). Participants, care providers and study investigators are unblinded to group allocation. All clinical endpoint events, NIHSS and mRS evaluations, and imaging metabolic assessments are independently adjudicated by a blinded endpoint adjudication committee who remain unaware of patient treatment assignment throughout the study to avoid assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: This study adopts a parallel-group design. Eligible participants are randomly assigned to either the intervention group receiving 10% fructose injection combined with standard intravenous thrombolysis and routine stroke treatment, or the control group receiving only standard intravenous thrombolysis and conventional medical management without fructose intervention. The two groups are followed up in parallel to compare neurological function recovery, imaging changes, cerebral neuronal metabolism and safety outcomes.

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 4, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CN (1)