Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone

NCT01196156 | Completed

• 1 other identifier: IMP 27143
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 28

Brief Summary

This non-interventional study for prospective follow up of a cohort of 220 subjects born small for gestational age (SGA) is planned for the purpose of finding out if normalisation of adult height is associated or not with metabolic alterations and if true, their magnitude and relevance as well as to detect warnings throughout the treatment period that may be useful for prevention or therapy. This study would help in answering the question if the SGA and growth hormone (GH) association results in insulin resistance and if affirmative, who develops it as well as its impact on other metabolic parameters that precedes type 2 diabetes.

Conditions

Infant, Small for Gestational Age

Keywords

Infant, Small for Gestational Age; Dwarfism Pituitary; Saizen; Somatropin; Growth Hormone; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• Changes in the insulin sensitivity index measured using HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)

  Once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason

  up to 10 years

Secondary Outcomes (11)

• Auxological parameter - Growth speed

  up to 10 years

• Auxological parameter - Height

  up to 10 years

• Auxological parameter - Weight in kilogram

  up to 10 years

• Auxological parameter - Plasma insulin growth factor (IGF-I), measured at the local laboratory

  up to 10 years

• Auxological parameter - Plasma insulin growth factor (IGF-I), measured at the central laboratory

  up to 10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children with growth disorder (current height \<-2.5 SD and height adjusted to parental stature \<-1 SD) in children born SGA with a weight and/or length at birth below -2 SD, that has not experimented a growth catch-up (growth speed \<0 SD during the last year) at 4 years old or afterwards.

You may qualify if:

• Children with growth disorder (current height \<-2.5 SD and height adjusted to parental stature \<-1 SD) in children born SGA with a weight and/or length at birth below -2 SD, that has not experimented a growth catch-up (growth speed \<0 SD during the last year) at 4 years old or afterwards were enrolled in the study
• Children undergoing treatment with somatropin from Serono
• Children whose parent or legal guardians, as well as the subject himself if 12 or more years old have given written permission to access their records

You may not qualify if:

• Children with closed epiphysis
• Children with known hypersensitivity to somatropin or to any excipients present in the injection powder or solvent
• Subjects with active neoplasms. Any anti-tumoral treatment must be completed prior to starting treatment with somatropin
• Subjects with evidence of progression or relapse of a subjacent intracranial lesion
• Subjects with acute critical diseases such as those that present complications after open heart surgery, abdominal surgery, polytraumatisms, acute respiratory failure or similar conditions

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck, S.L., Spain: collaborator

Study Sites (28)

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital Nostra Senyora de Meritxell

Andorra, Spain

Location

Hospital San Agustin

Avilés, Spain

Location

Hospital San Agustín

Avilés, Spain

Location

Hospital Materno Infantil de Badajoz

Badajoz, Spain

Location

Hospital de Cruces-Baracaldo

Barakaldo, Spain

Location

Hospital Sagrado Corazón

Barcelona, Spain

Location

Hospital Puerta del Mar de Cádiz

Cadiz, Spain

Location

Hospital Comarcal de Don Benito

Don Benito, Spain

Location

Hospital de Elche

Elche, Spain

Location

Hospital General de Elda

Elda, Spain

Location

Hospital Clínico San Cecilio

Granada, Spain

Location

Hospital SAS Jerez de la Frontera

Jerez de la Frontera, Spain

Location

Hospital Severo Ochoa

Leganés, Madrid, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Location

Hospital Univ. La Paz

Madrid, Spain

Location

Hospital Materno Infantil de

Málaga, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Hospital Son Espases

Palma de Mallorca, Spain

Location

Hospital Virgen del Camino

Pamplona, Spain

Location

Hospital Sant Joan de Reus

Reus, Spain

Location

Hospital Parc Taulí de Sabadell

Sabadell, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Spain

Location

Hospital Clínico Universitario

Santiago, Spain

Location

Hospital de Valme. Seville

Seville, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

Dwarfism, Pituitary; Insulin Resistance

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Director

  Merck, S.L., Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: September 8, 2010
• Study Start: September 30, 2005
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

ES (28)