The Efficacy and Safety of an Amino Acid Supplement in Adults
NCT05599282
Healthy, Insulin-Like Growth Factor I
London, Ontario, Canada
View Trial DetailsNCT Number: NCT07043504
The purpose of this study is to dynamically observe the dynamic changes of serum IGF-1 after intracerebral hemorrhage, explore the impact and correlation of serum IGF-1 with the severity of the patient's condition and prognosis, and provide a reference for clinical treatment timing.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Research Objectives
Experimental Methods
Screening Period:
Within 3 days after onset, record the demographic data, etiology, medical history, complications, disease course, and main clinical manifestations of the subjects during the screening period. Blood sampling for laboratory tests (between 06:00-08:00 in the morning within 3 days after onset) includes: complete blood count, IGF-1, GH, IGFBP-3, LDL-C, thyroid function T4, serum cortisol, ACTH, testosterone or progesterone, serum CRP, fasting blood glucose, glycated hemoglobin. Perform head CT and NIHSS scoring.
Follow-up Period:
At the 15th day, 1st month, and 2nd month of the subject's disease course:
Conduct laboratory tests for IGF-1, GH, and IGFBP-3. Evaluate using the Modified Barthel Index (MBI), Modified Rankin Scale (MRS), Glasgow Coma Scale (GCS), Mini-Mental State Examination (MMSE), PHQ-9 Depression Screening Scale (PHQ-9), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).
At the 4th month of the subject's disease course:
Perform laboratory tests for complete blood count, IGF-1, GH, IGFBP-3, LDL-C, thyroid function T4, serum cortisol, ACTH, testosterone or progesterone, CRP, fasting blood glucose, and glycated hemoglobin.
Evaluate using the same scales as above (MBI, MRS, GCS, MMSE, PHQ-9, WHOQOL-BREF).
Grouping Based on Dynamic Changes in Serum IGF-1:
Convert IGF-1 values to IGF-1 SD (standard deviation) by referencing the age-specific reference values for IGF-1 in healthy Chinese populations (Peking Union Medical College).
IGF-1 Decreased Group: IGF-1 < 0SD IGF-1 Normal Group: 0SD ≤ IGF-1 ≤ 2SD
Dynamic change-based grouping:
① Persistent IGF-1 Decrease Group: IGF-1 remains < 0SD throughout dynamic observation.
② IGF-1 Decrease to Normal Group: IGF-1 first < 0SD, then recovers to > 0SD.
③ Persistent IGF-1 Normal Group: IGF-1 remains > 0SD throughout dynamic observation.
Statistical Analysis Based on Experimental Data
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 days after intracerebral
Serum IGF-1 levels decrease in the acute phase after intracerebral hemorrhage, and the decrease is correlated with the severity of the condition. (The more severe the condition, the larger the number of patients with reduced IGF-1 levels, and the more significant the decrease in IGF-1 values.),The higher the IGF-1 level, the lower the NIHSS score.
Time frame: The 5th month
Patients with persistently decreasing IGF-1 levels have worse functional prognosis than those with persistently normal IGF-1 levels.
Contact information is provided by the study sponsor or research team.
Shengjing Hospital
Other
Study on the Dynamic Changes of Serum IGF-1 After Cerebral Hemorrhage and Its Correlation With Prognosis of Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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