Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype
NCT01616095
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
- 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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Bratislava,
- Bratislava,
- Lubochna,
- Modena,
- Nashville, Tennessee
- Liverpool, Merseyside
- Liverpool, Merseyside
Descriptive Information | |||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brief Title | Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype | ||||||||||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||||||||||
Brief Summary | 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
as well as how it influences the adipose tissue
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. | ||||||||||||||||||||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||||||||||||||||||||
Study Type | Observational | ||||||||||||||||||||||||||||||||||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional | ||||||||||||||||||||||||||||||||||||
Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||||||||||||||
Biospecimen | Retention: Samples With DNA Description: plasma 2.5 ml, serum 5 ml, adipose tissue 300 mg taken by the percutaneous biopsy of abdominal subcutaneous adipose tissue, in local anaesthesia. | ||||||||||||||||||||||||||||||||||||
Sampling Method | Probability Sample | ||||||||||||||||||||||||||||||||||||
Study Population | Twenty growth hormone deficient adults, receiving supplementation with rhGH for 5 years (extensively examined in 2005-2006, prior to the start of rhGH therapy) and 20 age-, gender- and BMI- matched controls will enter the study. Both, GHD patients and controls will undergo an extensive clinical protocol, identical to that performed in 2005 (Ukropec et al., 2008a). The possibility of drop-out of patients needs to be taken into consideration. Possible lowering of the numbers of participants due to drop-out of individuals tested in the Baseline Study will be resolved by either (i) using biological material obtained in the Baseline Study which was originally not subjected to an extensive molecular genetic testing due to the limited capacity and high cost of these analyses and/or by (ii) recruiting necessary amount of new patients with history of 5 years rhGH therapy (initial examination is missing). | ||||||||||||||||||||||||||||||||||||
Condition | Growth Hormone Deficiency | ||||||||||||||||||||||||||||||||||||
Intervention | Not Provided | ||||||||||||||||||||||||||||||||||||
Study Groups/Cohorts |
| ||||||||||||||||||||||||||||||||||||
Publications * | Ukropec J, Penesová A, Skopková M, Pura M, Vlcek M, Rádiková Z, Imrich R, Ukropcová B, Tajtáková M, Koska J, Zórad S, Belan V, Vanuga P, Payer J, Eckel J, Klimes I, Gasperíková D. Adipokine protein expression pattern in growth hormone deficiency predisposes to the increased fat cell size and the whole body metabolic derangements. J Clin Endocrinol Metab. 2008 Jun;93(6):2255-62. doi: 10.1210/jc.2007-2188. Epub 2008 Mar 11. | ||||||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||||||||||||||||||||||
Recruitment Information | |||||||||||||||||||||||||||||||||||||
Recruitment Status | Completed | ||||||||||||||||||||||||||||||||||||
Actual Enrollment | 44 | ||||||||||||||||||||||||||||||||||||
Original Estimated Enrollment | 40 | ||||||||||||||||||||||||||||||||||||
Actual Study Completion Date | August 2015 | ||||||||||||||||||||||||||||||||||||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||
Eligibility Criteria | Inclusion Criteria: We will follow inclusion-exclusion criteria which are very much like those used in the pilot study performed in 2005.
Exclusion Criteria:
| ||||||||||||||||||||||||||||||||||||
Sex/Gender |
| ||||||||||||||||||||||||||||||||||||
Ages | 21 Years to 50 Years (Adult) | ||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||
Listed Location Countries | Slovakia | ||||||||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||||||
NCT Number | NCT01616095 | ||||||||||||||||||||||||||||||||||||
Other Study ID Numbers | GH GIIR - 2011 | ||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||||||||||||||||||||||||||
Responsible Party | Jozef Ukropec, Slovak Academy of Sciences | ||||||||||||||||||||||||||||||||||||
Study Sponsor | Slovak Academy of Sciences | ||||||||||||||||||||||||||||||||||||
Collaborators | PFIZER, Bratislava, Slovakia | ||||||||||||||||||||||||||||||||||||
Investigators |
| ||||||||||||||||||||||||||||||||||||
PRS Account | Slovak Academy of Sciences | ||||||||||||||||||||||||||||||||||||
Verification Date | April 2018 |