Skip to content

The relationship between Klotho protein, fibroblast growth factor 23 and GH-IGF-1 axis in children with short stature and its effect on the efficacy of recombinant human growth hormone

The relationship between Klotho protein, fibroblast growth factor 23 and GH-IGF-1 axis in children with short stature and its effect on the efficacy of recombinant human growth hormone

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071806
Enrollment
Unknown
Registered
2023-05-25
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

short stature

Interventions

Idiopathic short stature(ISS):rhGH subcutaneous injection 0.1-0.2 IU / KG / D
Growth hormone deficiency(GHD):rhGH subcutaneous injection 0.1-0.2 IU / KG / D
Familial short stature group(CPP):rhGH subcutaneous injection 0.1-0.2 IU / KG / D
Control group:N/A
Small for Gestational Age group:rhGH subcutaneous injection 0.1-0.2 IU / KG / D
Turnner syndrome ( TS ) group:rhGH subcutaneous injection 0.1-0.2 IU / KG / D

Sponsors

Hebei General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 15 Years

Inclusion criteria

Inclusion criteria: Growth hormone deficiency, GHD group : ( 1 ) height meets the diagnostic criteria for short stature children ; ( 2 ) The growth rate was significantly lower than 7cm / year in 1-3 years old, 5cm / year in 3 years old-prepuberty, and 6cm / year in puberty. ( 3 ) The proportion of each part of the body ( trunk, limbs, etc. ) coordination, immature appearance ; ( 4 ) Bone age was one year behind the actual age ; ( 5 ) Two kinds of GH drug stimulation tests ( insulin, levodopa ) with different mechanisms of action showed that GH peak < 10ng / mL ; ( 6 ) Serum IGF1 level decreased significantly ; ( 7 ) Normal chromosome ; ( 8 ) Excluding other diseases that cause short stature. Idiopathic short stature ( ISS ) group : ( 1 ) Height met the diagnostic criteria for short stature children ; ( 2 ) The length and weight at birth were in the normal range ; ( 3 ) GH drug stimulation test showed that GH peak = 10ng / mL ; ( 4 ) Serum IGF1 concentration was normal ; ( 5 ) Normal or backward bone age ; ( 6 ) Normal chromosome ; ( 7 ) Excluding other diseases that cause short stature. Small for Gestational Age ( SGA ) group : ( 1 ) height meets the diagnostic criteria for children with short stature ; ( 2 ) meet the diagnostic criteria of SGA dwarfism ; ( 3 ) normal chromosome ; ( 4 ) Excluding other diseases that cause short stature. Familial short stature group : ( 1 ) height meets the diagnostic criteria for short stature children ; ( 2 ) The height of parents or one of parents is less than the height standard deviation of the same age, gender and race-2SD ; ( 3 ) normal chromosome ; ( 4 ) Excluding other diseases that cause short stature. Turnner syndrome ( TS ) group : ( 1 ) Girls showed unexplained growth retardation ; ( 2 ) Lack of secondary sexual characteristics ; ( 3 ) with one or more of the following : neonatal hand and foot edema, neck skin thickening, special physical characteristics : neck web, posterior hairline low, low ear position, small jaw, elbow valgus, nail dysplasia, pigmented nevus, high palatal arch, fourth metacarpal short, scoliosis, congenital cardiovascular abnormalities such as left heart abnormalities, aortic valve abnormalities, aortic dilatation, aortic coarctation, aortic arch extension, renal dysplasia, chronic otitis media, conductive or sensorineural deafness, learning disabilities, especially visual space or non-verbal skills disorders ; ( 4 ) Karyotype analysis showed that there was one X chromosome, and the other X chromosome was completely or partially deleted, or there were other structural abnormalities, with or without cell line mosaicism ; ( 5 ) Gonadotropin levels increased, low estrogen levels ; ( 6 ) Pelvic B-ultrasound indicated uterine and ovarian dysplasia.

Exclusion criteria

Exclusion criteria: ( 1 ) Patients with nutritional disorders such as obesity and weight loss ; ( 2 ) Patients with other endocrine diseases ( thyroid dysfunction, diabetes, adrenal insufficiency, etc. ) ; ( 3 ) Patients with acute diseases ( trauma, infection, chronic disease aggravation, etc. ) ; ( 4 ) Patients with chronic liver and kidney disease, heart and lung disease, bone disease, malignant tumor, chromosomal abnormalities, etc. ; ( 5 ) calcium and phosphorus metabolism disorders ; ( 6 ) those with backward intelligence development ; ( 7 ) Patients who used antibiotics, steroids or other drugs that may affect the experimental results in the last 3 months.

Design outcomes

Primary

MeasureTime frame
levels of serum FGF23;Klotho;IGF-1;ghrelin;bone age;peak GH;

Secondary

MeasureTime frame
Height,Weight,Tanner stages;

Countries

China

Contacts

Public ContactCheng Yaying

Hebei General Hospital

doctorcyy@126.com+86 135 0331 2606

Outcome results

None listed

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