GH and Cardiovascular Risk Factors
Effect of Growth Hormone Replacement Therapy on Cardiovascular Risk Factors in Adult Patients With Severe Growth Hormone Deficiency: Association With IGF-I Concentration
Rationale: Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both associated with increased metabolic risk. Since (U-shaped) associations of IGF-I, within the normal range, have also been found with cardiovascular risk factors and disease in the general population, it would be interesting to investigate if this association can also be found in growth hormone deficient (GHD) adults treated with Growth Hormone (GH). This could be of interest for endocrinologists prescribing GH in clinical practice because strict dosing may become even more important. Next to that, scientific evidence for clinical practice is wanted.
Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect on glucose metabolism, physical performance, and neuropsychological functioning of different levels of IGF-I in GH treated GHD men and women.
Study design: Open-label randomized trial.
Study population: At least 32 subjects, both childhood as adult onset GHD men and women, receiving GH treatment for at least one year, with an age between 20 and 65 years.
Intervention: At entry subjects are already receiving GH treatment according to general clinical practice, and are expected to demonstrate an IGF-I concentration of 0 - 1 SD score (SDS) (normal dose). The group of men and group of women will be randomized to receive either a decrease of their regular dose of GH treatment (IGF-I target level of -2 - -1 SDS) (low dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high dose) for at least 24 weeks.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 4
Kontakte und Standorte
Studienorte
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PO Box 7057
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Amsterdam, PO Box 7057, Niederlande, 1007 MB
- VU University Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Ongoing surveillance at our centre (VUmc)
- Stable substitution therapy for other pituitary hormone deficiencies
Exclusion Criteria:
- Subjects with a craniopharyngioma as cause of their GHD or pituitary deficiencies
- Contraindications for the use of GH treatment
- (Receiving treatment for) malignant disease (in the past)
- Cardiovascular event less than one year prior to inclusion
- Participation in other studies
- Subjects, who in the opinion of the investigator, are unsuitable in any other way to participate in this study
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Low dose Growth Hormone
Halve of the group of men and group of women will receive a decrease of their regular dose of Growth Hormone treatment, with the IGF-I target level of -2 - -1 SD score (low dose=LD).
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Andere Namen:
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Aktiver Komparator: High dose Growth Hormone
Halve of the group of men and group of women will receive an increase of their regular dose of Growth Hormone treatment, with the IGF-I target level of 1 - 2 SD score (high dose=HD).
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Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Change in cardiovascular risk (body composition and lipid profile)
Zeitfenster: 24 weeks
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24 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Change in cardiovascular risk (inflammatory markers, vascular stiffness, endothelial function, presence of the metabolic syndrome)
Zeitfenster: 24 weeks
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24 weeks
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Change in physical performance (muscle strength, physical activity)
Zeitfenster: 24 weeks
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24 weeks
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Change in glucose metabolism (fasting and 2hr postprandial glucose, insulin resistance)
Zeitfenster: 24 weeks
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24 weeks
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Change in neuropsychological functioning (QoL, cognition, mood)
Zeitfenster: 24 weeks
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24 weeks
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Madeleine L. Drent, MD PhD, Amsterdam Umc, Location Vumc
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- van Bunderen CC, Meijer RI, Lips P, Kramer MH, Serne EH, Drent ML. Titrating Growth Hormone Dose to High-Normal IGF-1 Levels Has Beneficial Effects on Body Fat Distribution and Microcirculatory Function Despite Causing Insulin Resistance. Front Endocrinol (Lausanne). 2021 Feb 9;11:619173. doi: 10.3389/fendo.2020.619173. eCollection 2020.
- van Bunderen CC, Deijen JB, Drent ML. Effect of low-normal and high-normal IGF-1 levels on memory and wellbeing during growth hormone replacement therapy: a randomized clinical trial in adult growth hormone deficiency. Health Qual Life Outcomes. 2018 Jul 6;16(1):135. doi: 10.1186/s12955-018-0963-2.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Störungen des Glukosestoffwechsels
- Stoffwechselerkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Erkrankungen des endokrinen Systems
- Erkrankungen des Bewegungsapparates
- Hypothalamische Erkrankungen
- Insulinresistenz
- Hyperinsulinismus
- Knochenerkrankungen
- Knochenerkrankungen, endokrine
- Hypophysenerkrankungen
- Kleinwuchs
- Knochenerkrankungen, Entwicklungs
- Hypopituitarismus
- Herz-Kreislauf-Erkrankungen
- Metabolisches Syndrom
- Zwergwuchs, Hypophyse
- Physiologische Wirkungen von Arzneimitteln
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Hormone
Andere Studien-ID-Nummern
- 2013/12
- U1111-1142-9659 (Andere Kennung: Universal Trial Number)
- 2012-005066-36 (EudraCT-Nummer)
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