RBR-29sg4xg Evaluation of Growth Hormone Treatment in adolescence: Effect on body composition, bones, glucose and lipids in patients...

Date of registration: 12/30/2022 ^(mm/dd/yyyy)
Last approval date : 12/30/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1280-7723

• Public title:

  en

  Evaluation of Growth Hormone Treatment in adolescence: Effect on body composition, bones, glucose and lipids in patients who were treated with this hormone

  pt-br

  Avaliação do Tratamento com Hormônio do Crescimento na adolescência: Efeito sobre a composição corporal, ossos, glicose e lípides em pacientes que foram tratados com esse hormônio

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 54766616.1.0000.0068
    Issuing authority: Plataforma Brasil
  • 1.511.705
    Issuing authority: Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo HCFMUSP

Sponsors

• Primary sponsor: Universidade de São Paulo
• Secondary sponsor:
  • Institution: Universidade de São Paulo
• Supporting source:
  • Institution: Universidade de São Paulo

Health conditions

• Health conditions:

  en

  Osteoporosis

  pt-br

  Osteoporose

• General descriptors for health conditions:

  en

  C26.404 Fractures, Bone

  pt-br

  C26.404 Fraturas de Ossos

• Specific descriptors:

  en

  C05.116.198.579 Osteoporosis

  pt-br

  C05.116.198.579 Osteoporose

Interventions

• Interventions:

  en

  This is a randomized, controlled, open study, and as described in the attached project evaluated by the CEP, with a duration of 24 months. Overall 50 adolescents of both sexes, aged 14 to 20 years, from the Pediatric Endocrinology outpatient clinic at the Children's Institute (Icr) of the University of São Paulo will be included. Confirmation of the persistence of GH deficiency will be performed by measuring insulin-like growth factor (IGF_I) and insulin tolerance test. According to the result, the participants will initially be divided into 2 groups, those with insufficient GH and those with sufficient GH (controls). Insufficient GH will be allocated by simple randomization, in a 1:1 ratio, into 2 groups: those who will discontinue somatropin, and those who will restart it (or experimental group). Somatropin will be administered in the experimental group, at an initial dose of 0.5 mg/day, subcutaneously, at night, six times a week. The dose will be titrated by the IGF_I dosage, keeping it between the mean and 2 standard deviations for sex and age. Both researchers and participants will know which group each participant will belong to. to the result, the participants will initially be divided into 2 groups, those with insufficient GH and those with sufficient GH (controls). Insufficient GH will be allocated by simple randomization, in a 1:1 ratio, into 2 groups: those who will discontinue somatropin, and those who will restart it (or experimental group). Somatropin will be administered in the experimental group, at an initial dose of 0.5 mg/day, subcutaneously, at night, six times a week. The dose will be titrated by the IGF_I dosage, keeping it between the mean and 2 standard deviations for sex and age. Both researchers and participants will know which group each participant will belong to.

  pt-br

  Trata-se de um estudo randomizado, controlado, aberto, e como descrito no projeto em anexo avaliado pelo CEP, com duração de 24 meses. Um total de 50 adolescentes de ambos os sexos, de 14 a 20 anos de idade, provenientes do ambulatório de Endocrinologia Pediátrica do Instituto da Criança (Icr) da Universidade de São Paulo serão incluídos no estudo. A confirmação da persistência da deficiência do GH será realizada pela dosagem do fator de crescimento insulina símile (IGF_I) e teste de tolerância à insulina. Conforme o resultado, os participantes serão inicialmente divididos em 2 grupos, os insuficientes de GH e os suficientes de GH (controles). Os insuficientes de GH serão alocados por randomização simples, na proporção de 1:1 em 2 grupos: os que suspenderão a somatropina, e aqueles que a reiniciarão (ou grupo experimental). A somatropina será administrada no grupo experimental, na dose inicial de 0,5 mg/dia, por via subcutânea, à noite, seis vezes por semana. A dose será titulada pela dosagem do IGF_I, mantendo-a entre a média e 2 desvios-padrão para sexo e idade. Tanto os pesquisadores quanto os participantes terão conhecimento a que grupo pertencerá cada participante.

• Descriptors:

  en

  D06.472.699.631.525.425.875 Human Growth Hormone

  pt-br

  D06.472.699.631.525.425.875 Hormônio do Crescimento Humano

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 05/17/2017 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  50	-	14 Y	20 Y

• Inclusion criteria:

  en

  both gender; 14 to 20 years of age; growth speed less than 2 cm/year; bone age equal to or greater than 15 years in girls and 16 years in boys; somatropin use for 3 consecutive years

  pt-br

  ambos os gêneros; 14 a 20 anos de idade; velocidade de crescimento menor que 2 cm/ano; idade óssea igual ou maior que 15 anos nas meninas e 16 anos nos meninos; uso de somatropina por 3 anos consecutivos

• Exclusion criteria:

  en

  chronic renal failure; type 1 diabetes mellitus; osteopathies; Prader Willi syndrome; chronic use of corticosteroids

  pt-br

  insuficiência renal crônica; diabetes mellitus tipo 1; osteopatias; síndrome de Padrer-Willi; uso crônico de corticosteroide

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	2	Open	Randomized-controlled	2

Outcomes

• Primary outcomes:

  en

  Expected Outcome 1: It is expected that the GH insufficient subjects who have discontinued treatment show a variation in bone mineral density; we will performe densitometry in all subjects; we will describe the variation at less 3% change at baseline and pos-treatment.

  pt-br

  Desfecho esperado 1: Espera-se que os insuficientes de GH que suspenderam o tratamento apresentem uma variação da densidade mineral óssea menor que 3%; verificado por meio da densitometria óssea, a partir da constatação de uma variação de pelo menos 3% nas medições pré e pós-intervenção.

• Secondary outcomes:

  en

  We do not expected secondary outcome.

  pt-br

  Não são esperados desfechos secundários.

Contacts

• Public contact
  • Full name: Valesca Mansur Kuba
  • • Address: Av. Dr. Enéas Carvalho de Aguiar
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +55112661-0000
  • Email: vmkuba@uol.com.br
  • Affiliation: Universidade de São Paulo
   
• Scientific contact
  • Full name: Valesca Mansur Kuba
  • • Address: Av. Dr. Enéas Carvalho de Aguiar
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +55112661-0000
  • Email: vmkuba@uol.com.br
  • Affiliation: Universidade de São Paulo
   
• Site contact
  • Full name: Valesca Mansur Kuba
  • • Address: Av. Dr. Enéas Carvalho de Aguiar
    • City: São Paulo / Brazil
    • Zip code: 05403-000
  • Phone: +55112661-0000
  • Email: vmkuba@uol.com.br
  • Affiliation: Universidade de São Paulo
   

Additional links:

• Download in ICTRP format