GH and Cardiovascular Risk Factors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. dr. M.L. Drent, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01877512
First received: June 11, 2013
Last updated: May 6, 2014
Last verified: May 2014

June 11, 2013
May 6, 2014
May 2013
April 2014   (final data collection date for primary outcome measure)
Change in cardiovascular risk (body composition and lipid profile) [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT01877512 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Growth Hormone Deficiency
  • Cardiovascular Diseases
  • Metabolic Syndrome
  • Cognition
  • Physical Activity
Drug: Change in daily dosage of Growth Hormone
Other Name: Change in daily dosage of Somatropin
  • Active Comparator: 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).
    Intervention: Drug: Change in daily dosage of Growth Hormone
  • Active Comparator: 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).
    Intervention: Drug: Change in daily dosage of Growth Hormone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01877512
2013/12, U1111-1142-9659, 2012-005066-36
Not Provided
Prof. dr. M.L. Drent, VU University Medical Center
VU University Medical Center
Not Provided
Principal Investigator: Madeleine L. Drent, MD PhD VU University Medical Center
VU University Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP