GH and Cardiovascular Risk Factors

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877512
• Other study ID #: 2013/12
• Secondary ID: U1111-1142-96592
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2013
• Last updated: May 6, 2014
• Start date: May 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognition
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency
• Metabolic Syndrome
• Metabolic Syndrome X
• Physical Activity

Intervention

Drug:
• Change in daily dosage of Growth Hormone

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam	PO Box 7057

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiovascular risk (body composition and lipid profile)		24 weeks
Secondary	Change in cardiovascular risk (inflammatory markers, vascular stiffness, endothelial function, presence of the metabolic syndrome)		24 weeks
Secondary	Change in physical performance (muscle strength, physical activity)		24 weeks
Secondary	Change in glucose metabolism (fasting and 2hr postprandial glucose, insulin resistance)		24 weeks
Secondary	Change in neuropsychological functioning (QoL, cognition, mood)		24 weeks