Clinical trial NCT04020666: Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism
Official title: Effects of Urinary Kallidinogenase on NIHSS Score, mRS Score, and Fasting Glucose Levels in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Abnormal Glucose Metabolism
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AIS combined with diabetes mellitus and impaired fasting glucose who was meets the Inclusion and Exclusion Criteria were enrolled in this prospective cohort study and divided into two groups.

Brief summary: Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose.

Detailed description: Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared.

Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years (male or female)
* Patients were admitted to hospital within 72h of stroke onset
* Diagnosis of acute ischemic stroke according to the criteria stated in the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China (2010), and patients were confirmed as acute ischemic cerebrovascular disease by head computed tomography (CT) or magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI)
* NIHSS score ranged from 3-21 points
* Patients were previously diagnosed with type 2 diabetes, in which they were in line with the 2006 WHO diagnostic criteria for diabetes, or they had fasting blood glucose of 6.1-6.9mmol/L and glycosylated hemoglobin (HbA1C) of\>6.1%
* Patients could cooperate with the test and evaluation of relevant indicators in the trial.

Exclusion criteria:

* Pregnant or lactating women
* Patients with severe heart, liver and kidney dysfunction
* Patients with a history of cerebrovascular disease and who still suffered from serious neurological dysfunction that had an influence on the trial
* Patients with physical disabilities, joint deformities or muscle lesions
* Patients were confirmed with intracranial hemorrhage by CT
* Patients were allergic to the study drug
* Patients suffering from severe systemic infection
* Patients who had participated in other clinical trials within 1 month
* For any reason, the researchers believed that the subject was unlikely to complete the study (such as cerebral infarction caused by cerebral embolism, intracranial arteritis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) and moyamoya disease; patients undergoing thrombolysis or thrombectomy after admission; patients and their families were unable to cooperate with follow-up.)

Primary outcomes:
measure: NIHSS Score at 90 Days
timeFrame: at 90 days after admission
Secondary outcomes:
measure: NIHSS Score at 10 Days、30 Days
timeFrame: at 10 days, 30 days after admission
measure: Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%)
timeFrame: at 90 days after admission
measure: mRS Score
timeFrame: 10 days, 30 days, and 90 days after admission
measure: fasting glucose levels
timeFrame: at admission and 10 days after admission
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Xiaopeng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: