Growth Hormone DeficiencyPhase 4NCT01877512
GH and Cardiovascular Risk Factors
A Phase 4 study testing Change in daily dosage of Growth Hormone in people with Growth Hormone Deficiency and Cardiovascular Diseases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Growth Hormone Deficiency, Cardiovascular Diseases, Metabolic Syndrome
- What is being tested?
- Change in daily dosage of Growth Hormone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing surveillance at our centre (VUmc)
- Stable substitution therapy for other pituitary hormone deficiencies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, PO Box 7057, 1007 MB
About this study
Official title: 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.
Read more
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.
- Conditions
- Growth Hormone Deficiency, Cardiovascular Diseases, Metabolic Syndrome, Cognition, Physical Activity
- Being tested
- Change in daily dosage of Growth Hormone
- Medical subject headings
- Dwarfism, Pituitary, Cardiovascular Diseases, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in daily dosage of Growth HormoneDrug
Also called Change in daily dosage of Somatropin
| Study group | Role | What they receive |
|---|---|---|
| Low dose Growth Hormone | Active comparator | 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). Receives: Drug: Change in daily dosage of Growth Hormone |
| High dose Growth Hormone | Active comparator | 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). Receives: Drug: Change in daily dosage of Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular risk (body composition and lipid profile)
Measured: 24 weeks
Secondary outcomes (4)
Change in cardiovascular risk (inflammatory markers, vascular stiffness, endothelial function, presence of the metabolic syndrome)
Measured: 24 weeks
Change in physical performance (muscle strength, physical activity)
Measured: 24 weeks
Change in glucose metabolism (fasting and 2hr postprandial glucose, insulin resistance)
Measured: 24 weeks
Change in neuropsychological functioning (QoL, cognition, mood)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. M.L. Drent, Amsterdam UMC, location VUmc
- Investigators
- Madeleine L. Drent, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877512
- Sponsor's protocol ID
- 2013/12
- Other IDs
- U1111-1142-9659, 2012-005066-36
- Status last verified
- May 2014
- First submitted
- 11 Jun 2013
- Last updated
- 7 May 2014
- Results posted
- No
Publications
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.
PubMed 33633687van 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.
PubMed 29980224
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Growth Hormone Replacement Therapy on Cardiovascular Risk Factors in Adult Patients With Severe Growth Hormone Deficiency: Association With IGF-I Concentration
- ClinicalTrials.gov ID
- NCT01877512
- Acronym / sponsor ID
- 2013/12
- Conditions
- Growth Hormone Deficiency, Cardiovascular Diseases, Metabolic Syndrome, Cognition, Physical Activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Growth Hormone | Active comparator | Drug: Change in daily dosage of Growth HormoneHalve 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 comparator | Drug: Change in daily dosage of Growth HormoneHalve 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). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ongoing surveillance at our centre (VUmc)
- Stable substitution therapy for other pituitary hormone deficiencies
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in daily dosage of Growth HormoneAlso: Change in daily dosage of Somatropin | Drug | High dose Growth Hormone, Low dose Growth Hormone |
Primary outcome
Change in cardiovascular risk (body composition and lipid profile)
Time frame: 24 weeks
4 secondary outcomes
Change in cardiovascular risk (inflammatory markers, vascular stiffness, endothelial function, presence of the metabolic syndrome)
Time frame: 24 weeks
Change in physical performance (muscle strength, physical activity)
Time frame: 24 weeks
Change in glucose metabolism (fasting and 2hr postprandial glucose, insulin resistance)
Time frame: 24 weeks
Change in neuropsychological functioning (QoL, cognition, mood)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Derived from this study: PubMed 33633687van 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.
- Derived from this study: PubMed 29980224van 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.
Related trials for Growth Hormone Deficiency
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Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
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RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeleine L. Drent, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Change in daily dosage of Growth Hormone in people with Growth Hormone Deficiency and Cardiovascular Diseases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular risk (body composition and lipid profile) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.