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Study · Non-randomized trial · n = 6 · 1993

17 results

Hormonal and metabolic effects and pharmacokinetics of recombinant insulin-like growth factor-I in growth hormone receptor deficiency/Laron syndrome.

Vaccarello MA, Diamond FB Jr, Guevara-Aguirre J, Rosenbloom AL, Fielder PJ, Gargosky S, Cohen P, Wilson K, Rosenfeld RG

The Journal of clinical endocrinology and metabolism1 Jul 1993Cited by 69 (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 study17

16 results from studies that gave the peptide. 16 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    Adults with GHRD had no hypoglycemia below 2.5 mmol/L during IGF-I treatment.

    In plain wordsAdults with GHRD had no blood sugar levels below the stated hypoglycemia threshold during IGF-I treatment.

    Outcome
    Not applicableHypoglycemia
    Study

    n = 6

    Outcome group
    Adverse events · Metabolic and weight
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Glucose threshold defining hypoglycemia
    < 2.5 mmol/L
    During IGF-I treatment, adults with GHRD

    Source sentences

    Summary
    Hypoglycemia (< 2.5 mmol/L) did not occur, and mean 2 h postprandial insulin levels were reduced.
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  2. 02HumanNon-randomized trialEfficacy outcome

    IGF-I reduced mean postprandial insulin in adults with GHRD.

    In plain wordsIGF-I reduced insulin after meals in adults with GHRD.

    Outcome
    DecreasePostprandial insulin
    Study

    n = 6

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Hypoglycemia (< 2.5 mmol/L) did not occur, and mean 2 h postprandial insulin levels were reduced.
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  3. 03HumanNon-randomized trialEfficacy outcome

    IGF-I increased urinary calcium twofold in adults with GHRD.

    In plain wordsIGF-I increased calcium in urine in adults with GHRD.

    Outcome
    IncreaseUrinary calcium
    Study

    n = 6

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Urinary calcium change
    2 fold
    During IGF-I therapy, adults with GHRD
    P value for urinary calcium increase
    < 0.01
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    Urinary calcium increased 2-fold (P < 0.01), and serum calcium was unchanged.
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  4. 04HumanNon-randomized trialEfficacy outcome

    Serum calcium did not change during IGF-I treatment in adults with GHRD.

    In plain wordsBlood calcium did not change during IGF-I treatment in adults with GHRD.

    Outcome
    No significant changeSerum calcium
    Study

    n = 6

    Outcome group
    Bone and joint · Musculoskeletal
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Urinary calcium increased 2-fold (P < 0.01), and serum calcium was unchanged.
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  5. 05HumanNon-randomized trialEfficacy outcome

    IGF-I suppressed integrated GH levels in adults with GHRD.

    In plain wordsIGF-I reduced growth hormone levels in adults with GHRD.

    Outcome
    DecreaseIntegrated GH level
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean integrated 24-h GH level
    6.5 micrograms/L
    Before IGF-I, adults with GHRD
    Mean integrated 24-h GH level
    1 micrograms/L
    During IGF-I, adults with GHRD
    Reported +/- uncertainty of mean integrated 24-h GH level (type unspecified)
    2.1 micrograms/L
    Before IGF-I, adults with GHRD
    Reported +/- uncertainty of mean integrated 24-h GH level (type unspecified)
    0.2 micrograms/L
    During IGF-I, adults with GHRD
    P value for mean integrated 24-h GH suppression
    < 0.05
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    The mean integrated 24-h GH level was suppressed (6.5 +/- 2.1 to 1 +/- 0.2 micrograms/L), as were the number of peaks, area under the curve, and clonidine-stimulated GH release (all P < 0.05).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  6. 06HumanNon-randomized trialEfficacy outcome

    IGF-I reduced the number of GH peaks in adults with GHRD.

    In plain wordsIGF-I reduced growth hormone peaks in adults with GHRD.

    Outcome
    DecreaseGH peaks
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    P value for GH peak number reduction
    < 0.05
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    The mean integrated 24-h GH level was suppressed (6.5 +/- 2.1 to 1 +/- 0.2 micrograms/L), as were the number of peaks, area under the curve, and clonidine-stimulated GH release (all P < 0.05).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  7. 07HumanNon-randomized trialEfficacy outcome

    IGF-I reduced GH area under the curve in adults with GHRD.

    In plain wordsIGF-I reduced overall growth hormone exposure in adults with GHRD.

    Outcome
    DecreaseGH area under curve
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    P value for GH area under the curve reduction
    < 0.05
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    The mean integrated 24-h GH level was suppressed (6.5 +/- 2.1 to 1 +/- 0.2 micrograms/L), as were the number of peaks, area under the curve, and clonidine-stimulated GH release (all P < 0.05).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  8. 08HumanNon-randomized trialEfficacy outcome

    IGF-I suppressed clonidine-stimulated GH release in adults with GHRD.

    In plain wordsIGF-I reduced growth hormone release after clonidine in adults with GHRD.

    Outcome
    DecreaseClonidine-stimulated GH release
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    P value for clonidine-stimulated GH release suppression
    < 0.05
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    The mean integrated 24-h GH level was suppressed (6.5 +/- 2.1 to 1 +/- 0.2 micrograms/L), as were the number of peaks, area under the curve, and clonidine-stimulated GH release (all P < 0.05).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  9. 09HumanNon-randomized trialPharmacokinetics

    In adults with GHRD, IGF-I reached a peak between 2-6 h after injection and remained elevated at 12 h.

    In plain wordsIn adults with GHRD, IGF-I levels peaked after injection and remained above pretreatment levels.

    Outcome
    IncreaseIGF-I concentrations
    Study

    n = 6

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Mean pretreatment IGF-I level
    36 micrograms/L
    Before IGF-I, adults with GHRD
    Pretreatment IGF-I as share of Ecuadorian control value
    19%
    Before IGF-I, adults with GHRD
    Ecuadorian control IGF-I value
    190 micrograms/L
    Control subjects
    Peak IGF-I level
    253 micrograms/L
    2-6 h after IGF-I injection
    IGF-I level at 12 h
    137 micrograms/L
    12 h after IGF-I injection
    Reported +/- uncertainty of mean pretreatment IGF-I level (type unspecified)
    2 micrograms/L
    Before IGF-I, adults with GHRD
    Reported +/- uncertainty of peak IGF-I level (type unspecified)
    11 micrograms/L
    2-6 h after IGF-I injection
    Reported +/- uncertainty of IGF-I level at 12 h (type unspecified)
    8 micrograms/L
    12 h after IGF-I injection

    1 more measurement in the study.

    Source sentences

    Summary
    The mean pretreatment IGF-I level (36 +/- 2 micrograms/L) was 19% of the Ecuadorian control value (190 +/- 15 micrograms/L), it achieved a peak (253 +/- 11 micrograms/L) between 2-6 h after IGF-I injection, and at 12 h it was 137 +/- 8 micrograms/L.
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  10. 10HumanNon-randomized trialPharmacokinetics

    IGF-I half-life did not significantly differ between days 1 and 7 in adults with GHRD.

    In plain wordsIn adults with GHRD, IGF-I half-life did not differ significantly between the first and last treatment days.

    Outcome
    No significant changeHalf-life
    Study

    n = 6

    Comparator
    Day 1
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Half-life
    8.2 h
    Day 1
    Half-life
    9.7 h
    Day 7
    Reported +/- uncertainty of half-life (type unspecified)
    1.5 h
    Day 1, adults with GHRD
    Reported +/- uncertainty of half-life (type unspecified)
    1.9 h
    Day 7, adults with GHRD

    Source sentences

    Summary
    There were no significant changes in the half-life (8.2 +/- 1.5 to 9.7 +/- 1.9 h) or metabolic clearance (0.35 +/- 0.1 to 0.24 +/- 0.05 mL/kg.min) between days 1 and 7; however, distribution volume increased (183 +/- 10 to 266 +/- 36 mL/kg; P < 0.03).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  11. 11HumanNon-randomized trialPharmacokinetics

    IGF-I metabolic clearance did not significantly differ between days 1 and 7 in adults with GHRD.

    In plain wordsIn adults with GHRD, IGF-I clearance did not differ significantly between the first and last treatment days.

    Outcome
    No significant changeMetabolic clearance
    Study

    n = 6

    Comparator
    Day 1
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Metabolic clearance
    0.35 mL/kg.min
    Day 1
    Metabolic clearance
    0.24 mL/kg.min
    Day 7
    Reported +/- uncertainty of metabolic clearance (type unspecified)
    0.1 mL/kg.min
    Day 1, adults with GHRD
    Reported +/- uncertainty of metabolic clearance (type unspecified)
    0.05 mL/kg.min
    Day 7, adults with GHRD

    Source sentences

    Summary
    There were no significant changes in the half-life (8.2 +/- 1.5 to 9.7 +/- 1.9 h) or metabolic clearance (0.35 +/- 0.1 to 0.24 +/- 0.05 mL/kg.min) between days 1 and 7; however, distribution volume increased (183 +/- 10 to 266 +/- 36 mL/kg; P < 0.03).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  12. 12HumanNon-randomized trialPharmacokinetics

    IGF-I distribution volume increased between days 1 and 7 in adults with GHRD.

    In plain wordsIn adults with GHRD, IGF-I distribution volume increased from the first to the last treatment day.

    Outcome
    IncreaseDistribution volume
    Study

    n = 6

    Comparator
    Day 1
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Distribution volume
    183 mL/kg
    Day 1
    Distribution volume
    266 mL/kg
    Day 7
    Reported +/- uncertainty of distribution volume (type unspecified)
    10 mL/kg
    Day 1, adults with GHRD
    Reported +/- uncertainty of distribution volume (type unspecified)
    36 mL/kg
    Day 7, adults with GHRD
    P value for distribution volume increase
    < 0.03
    Day 7 versus day 1, adults with GHRD

    Source sentences

    Summary
    There were no significant changes in the half-life (8.2 +/- 1.5 to 9.7 +/- 1.9 h) or metabolic clearance (0.35 +/- 0.1 to 0.24 +/- 0.05 mL/kg.min) between days 1 and 7; however, distribution volume increased (183 +/- 10 to 266 +/- 36 mL/kg; P < 0.03).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  13. 13HumanNon-randomized trialEfficacy outcome

    IGF-I reduced IGF-II levels in adults with GHRD.

    In plain wordsIGF-I reduced IGF-II levels in adults with GHRD.

    Outcome
    DecreaseIGF-II levels
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Baseline IGF-II as share of control value
    47%
    Before IGF-I, adults with GHRD
    IGF-II level
    273 micrograms/L
    Before IGF-I therapy
    IGF-II level
    178 micrograms/L
    During IGF-I therapy
    Reported +/- uncertainty of IGF-II level (type unspecified)
    10 micrograms/L
    Before IGF-I therapy
    Reported +/- uncertainty of IGF-II level (type unspecified)
    9 micrograms/L
    During IGF-I therapy
    P value for IGF-II decrease
    < 0.01
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    Baseline IGF-II levels were 47% of the control value and decreased during IGF-I therapy (273 +/- 10 to 178 +/- 9 micrograms/L; P < 0.01), correlating inversely with IGF-I levels (r = -0.3; P < 0.001).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  14. 14HumanNon-randomized trialMechanism

    During IGF-I therapy in adults with GHRD, IGF-II levels correlated inversely with measured IGF-I levels.

    In plain wordsIn adults with GHRD receiving IGF-I, higher measured IGF-I levels were linked to lower IGF-II levels.

    Outcome
    DecreaseIGF-I and IGF-II correlation
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Correlation of IGF-II with IGF-I levels (r)
    −0.3
    During IGF-I therapy, adults with GHRD
    P value for inverse correlation of IGF-II with IGF-I levels
    < 0.001
    During IGF-I therapy, adults with GHRD

    Source sentences

    Summary
    Baseline IGF-II levels were 47% of the control value and decreased during IGF-I therapy (273 +/- 10 to 178 +/- 9 micrograms/L; P < 0.01), correlating inversely with IGF-I levels (r = -0.3; P < 0.001).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  15. 15HumanNon-randomized trialEfficacy outcome

    IGF-I did not significantly affect IGFBP-3 levels in adults with GHRD.

    In plain wordsIGF-I did not significantly change IGFBP-3 levels in adults with GHRD.

    Outcome
    No significant changeIGFBP-3 levels
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Source sentences

    Summary
    Although IGF-binding protein-3 (IGFBP-3) levels were not significantly influenced, baseline IGFBP-2 levels (153% of the control) increased 45% (P < 0.01).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.
  16. 16HumanNon-randomized trialEfficacy outcome

    IGF-I increased IGFBP-2 levels in adults with GHRD.

    In plain wordsIGF-I increased IGFBP-2 levels in adults with GHRD.

    Outcome
    IncreaseIGFBP-2 levels
    Study

    n = 6

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 micrograms/kg every 12 h · subcutaneous · 7 daysAs given in this study (human).

    Measurements

    Baseline IGFBP-2 as share of control value
    153%
    Before IGF-I, adults with GHRD
    IGFBP-2 increase
    45%
    During IGF-I therapy, adults with GHRD
    P value for IGFBP-2 increase
    < 0.01
    During IGF-I therapy versus baseline, adults with GHRD

    Source sentences

    Summary
    Although IGF-binding protein-3 (IGFBP-3) levels were not significantly influenced, baseline IGFBP-2 levels (153% of the control) increased 45% (P < 0.01).
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.

Natural levels measured1

These results measure the body's own peptide. Nobody was given the peptide. They are not evidence about taking it. They are left out of key results, evidence counts and charts.

  1. 17HumanEndogenous levelObservational studyOther

    Adults with GHRD had pretreatment IGF-I levels at 19% of the Ecuadorian control value.

    In plain wordsAdults with GHRD had lower natural IGF-I levels than Ecuadorian controls.

    Outcome
    DecreasePretreatment IGF-I versus controls
    Study

    n = 6

    Comparator
    Ecuadorian controls
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones

    Measurements

    Pretreatment IGF-I
    36 micrograms/L
    adults with GHRD, before IGF-I
    Control IGF-I
    190 micrograms/L
    Ecuadorian control value
    Pretreatment IGF-I as share of control
    19%
    adults with GHRD vs Ecuadorian control

    Source sentences

    Summary
    The mean pretreatment IGF-I level (36 +/- 2 micrograms/L) was 19% of the Ecuadorian control value (190 +/- 15 micrograms/L)
    1 context sentence
    Summary · context
    We evaluated the pharmacokinetics and metabolic/hormonal effects of recombinant human IGF-I (40 micrograms/kg every 12 h) given sc for 7 days to six adults with GHRD.

    This result measures the body's own IGF-1 (mecasermin). Nobody was given the peptide. It is not evidence about taking it.

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

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

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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