Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01196156
First received: August 26, 2010
Last updated: March 3, 2014
Last verified: March 2014
History of Changes
  Purpose

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.


Condition
Infant, Small for Gestational Age

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Phase IV Study for Prospective Follow-up to Adult Height of a Cohort of Subjects Born Small for the Gestational Age and Treated With Growth Hormone

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Changes in the insulin sensitivity index measured using HOMA-IR (Homeostasis Model Assessment for Insulin Resistance) [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason


Secondary Outcome Measures:
  • Auxological parameter - Growth speed [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Growth speed will be measured using a wall stadiometer and quantified and assessed in cm/year. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Auxological parameter - Height [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Height will be measured using a wall stadiometer and quantified in standard deviations (SDS). Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Auxological parameter - Weight in kilogram [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Auxological parameter - Plasma insulin growth factor (IGF-I), measured at the local laboratory [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Plasma IGF-1 will be quantified in ng/ml. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Auxological parameter - Plasma insulin growth factor (IGF-I), measured at the central laboratory [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Plasma IGF-1 will be quantified in ng/ml. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Metabolic parameter - Fasting plasma insulin measured at the local laboratory [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Fasting plasma insulin will be quantified in μU/ml. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Metabolic parameter - Fasting plasma glucose measured at the local laboratory [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Fasting plasma insulin will be quantified in mmol/l. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Metabolic parameter - Plasma triglycerides measured locally [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    Plasma triglycerides will be quantified in mg/dl. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Metabolic parameter - High density lipoproteins (HDL) cholesterol measured locally [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    HDL-cholesterol will be quantified in mg/dl. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Metabolic parameter - Glycosylated haemoglobin (HbA1c) [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    HbA1c will be quantified in % over total Hb. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.

  • Metabolic parameter - Blood pressure (BP) [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
    BP will be measured in mmHg. Measurement occurs once a year per subject from the start of treatment with GH up to a year after finishing the treatment for any reason.
Enrollment: 442
Study Start Date: September 2005
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196156

Locations
Spain
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Nostra Senyora de Meritxell
Andorra, Spain
Hospital San Agustín
Avilés, Spain
Hospital San Agustin
Avilés), Spain
Hospital Materno Infantil de Badajoz
Badajoz, Spain
Hospital de Cruces-Baracaldo
Baracaldo, Spain
Hospital Sagrado Corazón
Barcelona, Spain
Hospital Puerta del Mar de Cádiz
Cadiz, Spain
Hospital Comarcal de Don Benito
Don Benito, Spain
Hospital de Elche
Elche, Spain
Hospital General de Elda
Elda, Spain
Hospital Clínico San Cecilio
Granada, Spain
Hospital SAS Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Hospital Univ. La Paz
Madrid, Spain
Hospital Materno Infantil de
Malaga, Spain
Hospital Virgen de la Arrixaca
Murcia, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Espases
Palma de Mallorca, Spain
Hospital Virgen del Camino
Pamplona, Spain
Hospital Sant Joan de Reus
Reus, Spain
Hospital Parc Taulí de Sabadell
Sabadell, Spain
Hospital Clínico de Salamanca
Salamanca, Spain
Hospital Clínico Universitario
Santiago, Spain
Hospital de Valme. Seville
Sevilla, Spain
Hospital Virgen Macarena
Sevilla, Spain
Sponsors and Collaborators
Merck KGaA
Merck, S.L., Spain
Investigators
Study Director: Medical Director Merck, S.L., Spain
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01196156     History of Changes
Other Study ID Numbers: IMP 27143
Study First Received: August 26, 2010
Last Updated: March 3, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Merck KGaA:
Infant, Small for Gestational Age
Dwarfism Pituitary
Saizen
Somatropin; Growth Hormone
Insulin resistance

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 26, 2015