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Trial record 1 of 1 for:    NCT01616095
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Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype (GHAT)

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ClinicalTrials.gov Identifier: NCT01616095
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
PFIZER, Bratislava, Slovakia
Information provided by (Responsible Party):
Jozef Ukropec, Slovak Academy of Sciences

Tracking Information
First Submitted Date June 7, 2012
First Posted Date June 11, 2012
Last Update Posted Date April 17, 2018
Actual Study Start Date April 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 8, 2012)
  • Effects of GH therapy to GHD adults - the whole body level [ Time Frame: 12 months ]
    to determine the effects of a long-term (6 years) growth hormone supplementation on the whole-body metabolic phenotype in adult GHD patients (namely (i) insulin sensitivity, (ii) energy expenditure, (iii) body fat distribution and (iv) bone mineral density, (v) glucose tolerance, (vi) hepatic and skeletal muscle lipid content as well as (vii) serum lipids and (viii) inflammatory markers in circulation.
  • GH therapy effects on the endocrine, metabolic & inflammatory properties of adipose tissue [ Time Frame: 2 years ]
    to investigate the effects of long-term (5 years) growth hormone supplementation on the subcutaneous adipose tissue (i) endocrine, (ii) metabolic and (iii) inflammatory phenotype in adult GHD patients, by extensive profiling of adipose tissue protein & gene expression (protein antibody arrays & real-time PCR) which could identify potential molecular mechanisms associated with abdominal obesity and insulin resistance modulated by rhGH replacement therapy.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 8, 2012)
  • comparison of GHD & control population [ Time Frame: 2 years ]
    to compare the whole-body metabolic profile and subcutaneous adipose tissue phenotype of rhGH supplemented GHD adults with that of the healthy control group
  • Identification of the adiposity-associated parameters [ Time Frame: 2 years ]
    to evaluate parameters associated primarily with adiposity which are largely independent on the severity of the GH deficiency
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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

  • 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.

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
  • Adults with Growth Hormone Deficiency
    if multiple hormonal deficiences exist, long term adequate supplementation is provided and tightly monitored.
  • Healthy Controls
    matched for BMI, age, and gender
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
 (submitted: July 18, 2013)
44
Original Estimated Enrollment
 (submitted: June 8, 2012)
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.

  • 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.
Sex/Gender
Sexes Eligible for Study: All
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
Principal Investigator: Jozef Ukropec, PhD Inst. Exp. Endocrinology SAS, Bratislava, Slovakia
Study Chair: Barbara Ukropcova, MD, PhD Inst. Exp. Endocrinology SAS, Bratislava, Slovakia
Study Director: Iwar Klimes, prof, MD, PhD Inst. Exp. Endocrinology SAS, Bratislava, Slovakia
Study Chair: Daniela Gasperikova, PhD Inst. Exp. Endocrinology SAS, Bratislava, Slovakia
Study Chair: Juraj Payer, prof, MD, PhD Dep. of Endocrinology, University Hospital, Comenius University, Bratislava
Study Chair: Martin Kuzma, MD Dep. of Endocrinology, University Hospital, Comenius University, Bratislava
Study Chair: Mikulas Pura, MD, PhD National Institute of Diabetology and Endocrinology, Lubochna, Slovakia
Study Chair: Peter Vanuga, MD, PhD National Institute of Diabetology and Endocrinology, Lubochna, Slovakia
Study Chair: Miroslav Vlcek, MD, PhD Inst Exp. Endocirnology SAS, Bratislava
Study Chair: Adela Penesova, MD, PhD Inst Exp. Endocirnology SAS, Bratislava
Study Chair: Miroslav Balaz, Mgr. Inst Exp. Endocirnology SAS, Bratislava
Study Chair: Timea Kurdiova, Mgr. Inst Exp. Endocirnology SAS, Bratislava
PRS Account Slovak Academy of Sciences
Verification Date April 2018