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Exploration of IGF-1 in the diagnosis and management for children's growth and metabolic diseases

Exploration of IGF-1 in the diagnosis and management for children's growth and metabolic diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062056
Enrollment
Unknown
Registered
2022-07-21
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, short stature and metabolic disorder of premature infants

Interventions

Premature infant group:Intravenous drip of rhIGF-1
short stature group:subcutaneous injection of rhIGF-1
T1DM group:subcutaneous injection of rhIGF-1
T2DM group:subcutaneous injection of rhIGF-1

Sponsors

Tianjin medical university general hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. To explore the changes of IGF-1 and IGF-BP 3 in cord blood and peripheral blood of newborns at different gestational ages, and explore the relationship between them and neonatal complications. Inclusion criteria: (1) Newborns aged 23-41+6 weeks admitted to Pediatric Intensive Care Unit of General Hospital of Tianjin Medical University from August 2022 to July 2024; (2) Parents of children sign informed consent form; (3) Maternal pregnancy data, delivery records, diagnosis and treatment records are complete; (4) The production process is smooth and there is no intrauterine asphyxia; (5) There are no known diseases that affect growth, development and respiration, such as chromosome abnormality, genetic metabolic diseases, congenital hypothyroidism, severe congenital heart disease, congenital malformation, etc.; 2. To explore the safety and clinical efficacy of rhIGF-1 in children with IGF-1 deficiency. Inclusion criteria: From 2016.01 to 2024.07, he was treated in the Pediatrics Department of Tianjin Medical University General Hospital, and met the following requirements: Test group: (1) the age is 2-14 years old; (2) The height is lower than -2SD or the 3rd percentile of the same age and gender; (3) Bone age height is 2 SD lower than genetic height; (4) It was diagnosed as primary IGF-1 deficiency, and IGF-1 was lower than that of 2 SD of the same age and sex; (5) Except secondary IGF-1 deficiency and other diseases affecting height; (6) Family members or I sign the informed consent form. Control group: (1) the age is 2-14 years old; (2) The height is shorter than -2SD or the 3rd percentile of the same age and gender; (3) It was diagnosed as idiopathic short stature, and IGF-1 was in the normal range; (4) Family members or I sign the informed consent form; (5) Except other diseases that affect height. 3. rhIGF-1 improves the metabolism of patients with T1DM. From 2016.01 to 2024.07, he was treated in the Pediatrics Department of Tianjin Medical University General Hospital. He met the following requirements and was assigned to rhIGF-1 group or routine treatment group according to age and sex: Inclusion criteria: (1) the age is 2-14 years old; (2) Diagnosed as T1DM; (3) After conventional treatment for 3 months, HbA1c = 7%; (4) Family members or I sign the informed consent form; (5) Except other hyperglycemia diseases. 4. rhIGF-1 improves metabolic syndrome and T2DM metabolism. Meet the following requirements, and be assigned to rhIGF-1 group or routine treatment group according to age and sex: Inclusion criteria: (1) the age is 2-14 years old; (2) Diagnosed as metabolic syndrome or T2DM; (3) After 3 months of routine treatment, the insulin resistance index > 3.0 or poor blood sugar control.

Exclusion criteria

Exclusion criteria: 1. To explore the changes of IGF-1 and IGF-BP 3 in cord blood and peripheral blood of newborns at different gestational ages, and explore the relationship between them and neonatal complications. Exclusion criteria: (1) Incomplete medical history data; (2) Birth injury, meconium aspiration, asphyxia in the uterus or during production, pneumothorax, severe anemia, persistent hypoglycemia, maternal diabetes requiring insulin, etc.; (3) suffering from diseases known to affect growth and development, such as chromosome abnormality, genetic metabolic diseases, congenital hypothyroidism, severe congenital heart disease, congenital malformation, etc.; 2. To explore the safety and clinical efficacy of rhIGF-1 in children with IGF-1 deficiency. Exclusion criteria: (1) Incomplete medical history data; (2) GH deficiency; (3) Suffering from diseases known to affect growth and development, such as chromosome abnormality, genetic metabolic diseases, congenital hypothyroidism, severe congenital heart disease, congenital malformation, etc.; 3. rhIGF-1 improves the metabolism of patients with T1DM. (1) Incomplete medical history data; (2) The blood sugar is well controlled by routine treatment; (3) Suffering from other diseases that affect growth and development and blood sugar; 4. rhIGF-1 improves metabolic syndrome and T2DM metabolism. (1) Incomplete medical history data; (2) Conventional treatment has good blood sugar control and improved insulin resistance; (3) Suffering from other diseases leading to obesity, hyperglycemia, dyslipidemia, and hypertension.

Design outcomes

Primary

MeasureTime frame
Insulin-like growth factor 1;Insulin-like growth factor binding protein 3;

Countries

China

Contacts

Public ContactRongxiu Zheng

Tianjin medical university general hospital

18622815720@163.com+86 18622815720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026