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
3 other identifiers
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 7, 2014
May 1, 2014
11 months
June 11, 2013
May 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in cardiovascular risk (body composition and lipid profile)
24 weeks
Secondary Outcomes (4)
Change in cardiovascular risk (inflammatory markers, vascular stiffness, endothelial function, presence of the metabolic syndrome)
24 weeks
Change in physical performance (muscle strength, physical activity)
24 weeks
Change in glucose metabolism (fasting and 2hr postprandial glucose, insulin resistance)
24 weeks
Change in neuropsychological functioning (QoL, cognition, mood)
24 weeks
Study Arms (2)
Low dose Growth Hormone
ACTIVE COMPARATORHalve 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).
High dose Growth Hormone
ACTIVE COMPARATORHalve 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).
Interventions
Eligibility Criteria
You may qualify if:
- Ongoing surveillance at our centre (VUmc)
- Stable substitution therapy for other pituitary hormone deficiencies
You may not qualify if:
- 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)
- Participation in other studies
- Subjects, who in the opinion of the investigator, are unsuitable in any other way to participate in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VU University Medical Center
Amsterdam, PO Box 7057, 1007 MB, Netherlands
Related Publications (2)
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.
PMID: 33633687DERIVEDvan 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.
PMID: 29980224DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madeleine L. Drent, MD PhD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 13, 2013
Study Start
May 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 7, 2014
Record last verified: 2014-05