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

Learn more about:
Related Clinical Trial
Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy Impact of GH Measurements on GHD Diagnosis Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™ The Impact of the Use of Recombinant Human Growth Hormone on ADHD Characteristics in Children and Adolescents Constructing an Insulin-Like Growth Factor-based Prediction Model Peripheral Metabolic Effects of Somatostatin Chromosome 18 Clinical Research Center The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids. An Observational Study on Treatment Compliance by Children Treated With Growth Hormone A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects Effectiveness of Growth Hormone Releasing Hormone in Reducing Abdominal Fat in People Who Are Obese Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters) A Study to Optimize Growth Hormone Dosing in Children With Chronic Kidney Disease by Measuring IGF-1 Levels in Blood Safety and Efficacy of Long-term Somatropin Treatment in Adults Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle Genotropin Study Assessing Use of Injection Pen Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary Validation of a Questionnaire That Identifies the Reasons for Non-adherence to Existing Growth Hormone Therapy Treatment of Children With Insufficient Secretion of Growth Hormone Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD Anterior Pituitary Hormone Replacement in Traumatic Brain Injury Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA) Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Inter-Assay Growth Hormone and IGF-I Variability A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy Easypod United States User Trial National Cooperative Growth Study in CKD Low and Conventional Dose of Somatropin in Growth Hormone Deficient Adult Patients Practicability and Acceptability of Stylomax® in Children Growth Hormone’s Effect on the Cardiovascular System Exploring Interactions Between Growth Hormone and the Microbiome Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children Phase 1 Safety Study of ALRN-5281 in Healthy Subjects Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Growth Hormone and Chromosome 18q- and Abnormal Growth An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood Study of TV-1106 in Growth Hormone-Deficient Adults Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Low Dose Growth Hormone (GH) on Insulin Sensitivity and Cortisol Production Rates Gene Expression in Monocytes of Growth Hormone Deficient Children Study of Pituitary Size and Function in Familial Dwarfism of Sindh Adipocyte Function and Somtropin Deficiency Sustained Release Formulation of Somatropin (rDNA Origin)for Injection Molecular Basis of the Growth Axis in Short Stature Cardiac and Skeletal Muscle Energy Metabolism in Abnormal Growth Hormone States The Effects of Growth Hormone (GH) on Lipid Depots The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing Metabolic Endocrinology and Growth Hormone in Adults Growth Hormone Treatment of Young Growth Hormone-Deficient Adults Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) rhGH Therapy on Hepatic Drug Metabolism Skeletal Muscle Effects of GH in Boys Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas Adipose Tissue and Serum Inflammation in GH Deficiency Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy

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


Primary Outcome

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

Secondary Outcome

 comparison of GHD & control population


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.


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

Recruitment Information

Estimated Enrollment


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

        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.




21 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Jozef Ukropec, PhD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID

GH GIIR - 2011

Responsible Party

Principal Investigator

Study Sponsor

Slovak Academy of Sciences


 PFIZER, Bratislava, Slovakia

Study Sponsor

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

Verification Date

April 2018