Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype

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.
    

Study Type

Observational

Primary Outcome

Effects of GH therapy to GHD adults - the whole body level

Secondary Outcome

 comparison of GHD & control population

Condition

Growth Hormone Deficiency

Study Arms / Comparison Groups

 Adults with Growth Hormone Deficiency

Description:  if multiple hormonal deficiences exist, long term adequate supplementation is provided and tightly monitored.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

44

Start Date

April 2011

Completion Date

August 2015

Primary Completion Date

May 2013

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.
      

Gender

All

Ages

21 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jozef Ukropec, PhD, , 

Location Countries

Slovakia

Location Countries

Slovakia

NCT ID

NCT01616095

Organization ID

GH GIIR - 2011

Responsible Party

Principal Investigator

Study Sponsor

Slovak Academy of Sciences

Collaborators

 PFIZER, Bratislava, Slovakia

Study Sponsor

Jozef Ukropec, PhD, Principal Investigator, Inst. Exp. Endocrinology SAS, Bratislava, Slovakia

Verification Date

April 2018