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Study · Randomized controlled trial · n = 78 · 2001

13 results

Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age.

Sas T, Mulder P, Aanstoot HJ, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A

Clinical endocrinology1 Feb 2001Cited by 60 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study13

13 results from studies that gave the peptide. 13 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In short children born small for gestational age, observed metabolic changes did not differ between GH dosage groups.

    In plain wordsIn short children born small for gestational age, metabolic changes did not differ between GH doses.

    Outcome
    No significant changeMetabolic changes by dose
    Study

    n = 78

    Comparator
    3 IU/(m(2) body surface.day)
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    None of the observed changes were different between the GH dosage groups.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  2. 02HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, impaired glucose tolerance occurred in 8% before GH and 4% after 6 years.

    In plain wordsIn short children born small for gestational age, impaired glucose tolerance was less frequent after GH than before treatment.

    Outcome
    DecreaseImpaired glucose tolerance
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Measurements

    Children with impaired glucose tolerance
    6 children of 78
    before treatment
    Impaired glucose tolerance prevalence
    8%
    before treatment
    Impaired glucose tolerance prevalence
    4%
    after 6 years of GH

    Source sentences

    Summary
    Before treatment, the glucose response to oral glucose after 120 min was in six of the 78 children (8%) above 7.8 mmol/l but below 11.1 mmol/l, indicating impaired glucose tolerance (IGT), whereas after 6 years of GH treatment, IGT was found in 4% of the children.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  3. 03HumanNon-randomized trialSafety outcome

    No short children born small for gestational age developed diabetes mellitus during GH treatment.

    In plain wordsNo short children born small for gestational age developed diabetes during GH treatment.

    Outcome
    Not applicableDiabetes mellitus
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    None of the children developed diabetes mellitus.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  4. 04HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, fasting glucose increased by 0.5 mmol/l after one year of GH, without further increase.

    In plain wordsIn short children born small for gestational age, fasting glucose increased during the first GH year and then remained stable.

    Outcome
    IncreaseFasting glucose
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Measurements

    Fasting glucose increase
    0.5 mmol/l
    after 1 year of GH

    Source sentences

    Summary
    Mean fasting glucose levels had increased significantly by 0.5 mmol/l after 1 year of GH treatment, without a further increase thereafter.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  5. 05HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, glucose AUCab was lower after 6 years of GH than at baseline.

    In plain wordsIn short children born small for gestational age, glucose AUCab was lower after GH than at baseline.

    Outcome
    DecreaseGlucose AUC adjusted for fasting
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    The 2-h area under the curve adjusted for fasting levels (AUCab) for glucose and the HbA(1c) levels were lower after 6 years of GH treatment compared to baseline.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  6. 06HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, HbA1c was lower after 6 years of GH than at baseline.

    In plain wordsIn short children born small for gestational age, HbA1c was lower after GH than at baseline.

    Outcome
    DecreaseHbA1c
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    The 2-h area under the curve adjusted for fasting levels (AUCab) for glucose and the HbA(1c) levels were lower after 6 years of GH treatment compared to baseline.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  7. 07HumanNon-randomized trialSafety outcome

    In short children born small for gestational age, all HbA1c levels remained in the normal range during GH treatment.

    In plain wordsIn short children born small for gestational age, all HbA1c levels were normal during GH treatment.

    Outcome
    Not applicableHbA1c normal range
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    During GH treatment, all HbA(1c) levels were in the normal range.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  8. 08HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, GH increased fasting insulin, with further increases from one to six years.

    In plain wordsIn short children born small for gestational age, fasting insulin increased during GH treatment.

    Outcome
    IncreaseFasting insulin
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    In contrast to the effects on glucose levels, GH treatment induced considerably higher fasting insulin levels and glucose-stimulated insulin levels.
    3 context sentences
    Summary · context
    The increase in AUCab for insulin occurred particularly during the first year of treatment, whereas the fasting insulin levels showed a further increase from one to six years.
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  9. 09HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, GH increased glucose-stimulated insulin levels.

    In plain wordsIn short children born small for gestational age, insulin after glucose increased during GH treatment.

    Outcome
    IncreaseGlucose-stimulated insulin
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    In contrast to the effects on glucose levels, GH treatment induced considerably higher fasting insulin levels and glucose-stimulated insulin levels.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  10. 10HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, insulin AUCab increased particularly during the first year of GH treatment.

    In plain wordsIn short children born small for gestational age, insulin AUCab increased particularly during the first GH year.

    Outcome
    IncreaseInsulin AUC adjusted for fasting
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    The increase in AUCab for insulin occurred particularly during the first year of treatment, whereas the fasting insulin levels showed a further increase from one to six years.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  11. 11HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, the 30-min insulin-to-glucose ratio increased during GH versus treatment start.

    In plain wordsIn short children born small for gestational age, the insulin-to-glucose ratio at 30 minutes increased during GH.

    Outcome
    Increase30-minute insulin-to-glucose ratio
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    As a result, the 30- and 120-min ratios of insulin to glucose were higher during GH treatment compared to the start of treatment.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  12. 12HumanNon-randomized trialEfficacy outcome

    In short children born small for gestational age, the 120-min insulin-to-glucose ratio increased during GH versus treatment start.

    In plain wordsIn short children born small for gestational age, the insulin-to-glucose ratio at 120 minutes increased during GH.

    Outcome
    Increase120-minute insulin-to-glucose ratio
    Study

    n = 78

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    As a result, the 30- and 120-min ratios of insulin to glucose were higher during GH treatment compared to the start of treatment.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.
  13. 13HumanObservational studyEfficacy outcome

    During GH treatment, children who remained prepubertal had glucose and insulin patterns similar to children who entered puberty.

    In plain wordsDuring GH treatment, children who remained prepubertal had glucose and insulin patterns similar to children who entered puberty.

    Outcome
    No significant changeGlucose and insulin patterns by puberty
    Study

    n: not reported in source

    Comparator
    Children who entered puberty
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    3 or 6 IU/(m(2) body surface.day) · 6 yearsAs given in this study (human).

    Source sentences

    Summary
    The children who remained prepubertal during the entire study period showed similar patterns in glucose and insulin levels compared to the children who entered puberty.
    2 context sentences
    Summary · context
    In a prospective, randomised double-blind, dose-response multicentre trial, the effect of GH treatment on CH metabolism was evaluated, comparing two GH dosages [3 vs. 6 IU/(m(2) body surface.day)].
    Summary · context
    Seventy-eight children with short stature (height SD-score < - 1.88) born small for gestational age (birth length SD-score < - 1.88) being all prepubertal with a mean (SD) chronological age of 7.3 (2.2) years before start of treatment.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT01697644

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Novo Nordisk A/Sn = 75Oct 1990 to May 2005

Foetal Growth Problem · Small for Gestational Age

Trial pageClinicalTrials.govUpdated 18 Jan 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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