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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)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck KGaA
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01196156
First received: August 26, 2010
Last updated: May 23, 2017
Last verified: May 2017
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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:
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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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: | 443 |
| Actual Study Start Date: | September 30, 2005 |
| Estimated Study Completion Date: | February 29, 2020 |
| Estimated Primary Completion Date: | December 31, 2019 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01196156
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 Agustin | |
| Avilés), Spain | |
| Hospital San Agustín | |
| 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
| 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: | May 23, 2017 |
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 Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017