This trial is active, not recruiting.

Condition growth hormone deficiency
Sponsor Slovak Academy of Sciences
Collaborator PFIZER, Bratislava, Slovakia
Start date June 2011
End date May 2013
Trial size 44 participants
Trial identifier NCT01616095, GH GIIR - 2011


This study is designed as a follow up study to that performed in 2005.

In the Baseline study (2005) extensive clinical whole body metabolic phenotyping was combined with in depth molecular and cellular biology analyses aimed at investigating the adipose tissue morphology as well as metabolic and inflammatory phenotypes in the adult GHD patients. Results published in (Ukropec et al., 2008)

In this study identical endpoints will be investigated with the same methodology and within the same population; in order to seek relevant answers to questions on how the 6-yrs of rhGH therapy affects the

- whole body insulin sensitivity

- energy expenditure

- body fat distribution

- hepatic and skeletal muscle lipid content;

as well as how it influences the adipose tissue

- endocrine,

- metabolic &

- inflammatory phenotypes.

The strength of the planned study lies in the extensive whole body and adipose tissue phenotyping before and after the 6-year rhGH replacement therapy, that allows to determine the long-term effects of rhGH replacement therapy in GHD adults.

Envisaged weakness is the limited size of the population; GHD adults (n=20); controls [age BMI and gender matched] (n=20). This, however, reflects [is limited by] the complexity of the study protocol as well as the stringency of the inclusion criteria.

The clinical data obtained by methods of - integrated physiology would provide an excellent interpretation background for molecular-genetic studies at the tissue (adipose tissue) and cellular (adipocytes) level. Integration of the two could bring a new quality in the investigators understanding of metabolic derangements present in GHD, and will allow extending the investigators knowledge on the mechanisms of the long-term rhGH-therapy-induced improvement on body composition, metabolic health and the cardiovascular risk.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
if multiple hormonal deficiences exist, long term adequate supplementation is provided and tightly monitored.
matched for BMI, age, and gender

Primary Outcomes

Effects of GH therapy to GHD adults - the whole body level
time frame: 12 months
GH therapy effects on the endocrine, metabolic & inflammatory properties of adipose tissue
time frame: 2 years

Secondary Outcomes

comparison of GHD & control population
time frame: 2 years
Identification of the adiposity-associated parameters
time frame: 2 years

Eligibility Criteria

Male or female participants from 21 years up to 50 years old.

Inclusion Criteria: We will follow inclusion-exclusion criteria which are very much like those used in the pilot study performed in 2005. - Briefly, duration of the GHD prior to entering the study should last for at least 3 years prior rhGH treatment starts. Age of individuals eligible to enter should be 20-50 years old. All patients and healthy control volunteers will provide the witnessed written informed consent before entry into the study. - It has to be noted that differences in the etiology of GHD might influence several of the outcomes we plan to measure. Presence or absence of possible bias should therefore be excluded for each specific outcome prior further statistical data analysis. Individuals with different degree of pituitary deficiency will therefore be eligible to enter the study. - Complex information on the adequacy of the hormone replacement therapy will be based on the serum levels of growth hormone, insulin-like growth factor 1, free thyroid hormone, testosterone/estradiol, urinary free cortisol FT4, and morning cortisol. Examination and laboratory testing relevant to this study will be performed within 6 months of entering the study. The 24-hour urinary free cortisol will only be determined in individuals hospitalized in a period of two month prior to the study entry. Exclusion Criteria: - None of the patients should receive lipid lowering treatment. Patients with malignant disease, diabetes mellitus, existing vascular disease and uncontrolled hypertension are not eligible to enter this study.

Additional Information

Official title The Effect of a Long-Term Growth Hormone Supplementation on the Whole-Body Metabolic Characteristics and Adipose Tissue Phenotype in Growth Hormone Deficient Adults: the 5-yr Follow-up
Principal investigator Jozef Ukropec, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Slovak Academy of Sciences.