GH and Cardiovascular Risk Factors

This study is currently recruiting participants.
Verified June 2013 by VU University Medical Center
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: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
Cardiovascular Diseases
Metabolic Syndrome
Cognition
Physical Activity
Drug: Change in daily dosage of Growth Hormone
Phase 4

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

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Primary Outcome Measures:
  • Change in cardiovascular risk (body composition and lipid profile) [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Change in daily dosage of Growth Hormone
Other Name: Change in daily dosage of Somatropin
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).
Drug: Change in daily dosage of Growth Hormone
Other Name: Change in daily dosage of Somatropin

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877512

Contacts
Contact: Christa C. van Bunderen, MD 0031 20 44 49826 c.vanbunderen@vumc.nl

Locations
Netherlands
VU University Medical Center Recruiting
Amsterdam, PO Box 7057, Netherlands, 1007 MB
Sub-Investigator: Christa C. van Bunderen, MD         
Sponsors and Collaborators
VU University Medical Center
Investigators
Principal Investigator: Madeleine L. Drent, MD PhD VU University Medical Center
  More Information

No publications provided

Responsible Party: Prof. dr. M.L. Drent, MD PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01877512     History of Changes
Other Study ID Numbers: 2013/12, U1111-1142-9659, 2012-005066-36
Study First Received: June 11, 2013
Last Updated: June 11, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Cardiovascular Diseases
Metabolic Syndrome X
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014