Insulin-Like Growth Factor INCT07043504
Study on Dynamic Changes of Serum IGF-1 Post-Cerebral Hemorrhage and Its Prognostic Correlation
An observational study of Insulin-Like Growth Factor I, run by Shengjing Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin-Like Growth Factor I
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with intracerebral hemorrhage from Shengjing Hospital Affiliated to China Medical University and those from Northern Theater General Hospital
Who may be able to join
- Aged 18 to 75 years old;
- Patients with intracerebral hemorrhage (NIHSS ≥5 points);
- No history of cerebrovascular diseases with residual functional impairment before brain injury;
- Hospitalized within 72 hours after injury;
- BMI ≤28.
Who cannot join
- Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction;
- Glycated hemoglobin >9.0% at screening;
- History of hypothalamic-pituitary related diseases or severe endocrine diseases;
- Use of drugs affecting endocrine function (such as glucocorticoids, growth hormones) within the past six months;
- Pregnant patients. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Dynamic Changes of Serum IGF-1 After Cerebral Hemorrhage and Its Correlation With Prognosis of Patients
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.
Read the detailed description
Research Objectives
- Monitor the dynamic changes in serum IGF-1 concentration in patients with intracerebral hemorrhage at different time points (within 3 days, 14 days, 1 month, 2 months, and 4 months after onset).
- Analyze the correlation between serum IGF-1 levels and the severity of intracerebral hemorrhage, imaging findings, and prognosis.
- Explore the clinical value of serum IGF-1 as a biomarker for intracerebral hemorrhage repair.
- Provide a reference for the clinical treatment timing of IGF-1-related drugs and therapies (such as rh growth hormone, rhIGF-1, etc.). 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
- Conditions
- Insulin-Like Growth Factor I
- Keywords
- Intracerebral Hemorrhage, Prognosis, IGF-1
- Medical subject headings
- Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between serum IGF-1 levels within 3 days after intracerebral hemorrhage and the severity of the condition (referring to NIHSS score)
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.
Measured: 3 days after intracerebral
Secondary outcomes (1)
The correlation between the dynamic change trend of IGF-1 after intracerebral hemorrhage and the prognosis of patients
Patients with persistently decreasing IGF-1 levels have worse functional prognosis than those with persistently normal IGF-1 levels.
Measured: The 5th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin-Like Growth Factor IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Yanmei, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043504
- Sponsor's protocol ID
- 2025PS1176K(X1)
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Dynamic Changes of Serum IGF-1 After Cerebral Hemorrhage and Its Correlation With Prognosis of Patients
- ClinicalTrials.gov ID
- NCT07043504
- Acronym / sponsor ID
- 2025PS1176K(X1)
- Conditions
- Insulin-Like Growth Factor I
- Keywords
- Intracerebral Hemorrhage, Prognosis, IGF-1
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Objectives
- Monitor the dynamic changes in serum IGF-1 concentration in patients with intracerebral hemorrhage at different time points (within 3 days, 14 days, 1 month, 2 months, and 4 months after onset).
- Analyze the correlation between serum IGF-1 levels and the severity of intracerebral hemorrhage, imaging findings, and prognosis.
- Explore the clinical value of serum IGF-1 as a biomarker for intracerebral hemorrhage repair.
- Provide a reference for the clinical treatment timing of IGF-1-related drugs and therapies (such as rh growth hormone, rhIGF-1, etc.). 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with intracerebral hemorrhage from Shengjing Hospital Affiliated to China Medical University and those from Northern Theater General Hospital
Key inclusion criteria (5 listed)
- Aged 18 to 75 years old;
- Patients with intracerebral hemorrhage (NIHSS ≥5 points);
- No history of cerebrovascular diseases with residual functional impairment before brain injury;
- Hospitalized within 72 hours after injury;
- BMI ≤28.
Key exclusion criteria (5 listed)
- Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction;
- Glycated hemoglobin >9.0% at screening;
- History of hypothalamic-pituitary related diseases or severe endocrine diseases;
- Use of drugs affecting endocrine function (such as glucocorticoids, growth hormones) within the past six months;
- Pregnant patients. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The relationship between serum IGF-1 levels within 3 days after intracerebral hemorrhage and the severity of the condition (referring to NIHSS score)
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.
1 secondary outcome
The correlation between the dynamic change trend of IGF-1 after intracerebral hemorrhage and the prognosis of patients
Time frame: The 5th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin-Like Growth Factor I, run by Shengjing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YanMei Yin, Master (18940259354, yym15998315189@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between serum IGF-1 levels within 3 days after intracerebral hemorrhage and the severity of the condition (referring to NIHSS score) (time frame: 3 days after intracerebral). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.