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

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ClinicalTrials.gov Identifier: NCT01196156
Recruitment Status : Completed
First Posted : September 8, 2010
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

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.

Condition or disease
Infant, Small for Gestational Age

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Study Type : Observational
Actual Enrollment : 443 participants
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
Actual Study Start Date : September 30, 2005
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones




Primary Outcome Measures :
  1. Changes in the insulin sensitivity index measured using HOMA-IR (Homeostasis Model Assessment for Insulin Resistance) [ Time Frame: up to 10 years ]
    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 :
  1. Auxological parameter - Growth speed [ Time Frame: up to 10 years ]
    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.

  2. Auxological parameter - Height [ Time Frame: up to 10 years ]
    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.

  3. Auxological parameter - Weight in kilogram [ Time Frame: up to 10 years ]
    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.

  4. Auxological parameter - Plasma insulin growth factor (IGF-I), measured at the local laboratory [ Time Frame: up to 10 years ]
    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.

  5. Auxological parameter - Plasma insulin growth factor (IGF-I), measured at the central laboratory [ Time Frame: up to 10 years ]
    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.

  6. Metabolic parameter - Fasting plasma insulin measured at the local laboratory [ Time Frame: up to 10 years ]
    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.

  7. Metabolic parameter - Fasting plasma glucose measured at the local laboratory [ Time Frame: up to 10 years ]
    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.

  8. Metabolic parameter - Plasma triglycerides measured locally [ Time Frame: up to 10 years ]
    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.

  9. Metabolic parameter - High density lipoproteins (HDL) cholesterol measured locally [ Time Frame: up to 10 years ]
    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.

  10. Metabolic parameter - Glycosylated haemoglobin (HbA1c) [ Time Frame: up to 10 years ]
    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.

  11. Metabolic parameter - Blood pressure (BP) [ Time Frame: up to 10 years ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196156


Locations
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Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck, S.L., Spain
Investigators
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Study Director: Medical Director Merck, S.L., Spain
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01196156    
Other Study ID Numbers: IMP 27143
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Merck KGaA, Darmstadt, Germany:
Infant, Small for Gestational Age
Dwarfism Pituitary
Saizen
Somatropin; Growth Hormone
Insulin resistance