Effects of Growth Hormone Supplementation to Adults With Growth Hormone

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01616095
Study type	Observational
Source	Slovak Academy of Sciences
Contact
Status	Completed
Phase
Start date	April 2011
Completion date	August 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02243852` - Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)	N/A
Completed	`NCT01440686` - Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers	Phase 1
Completed	`NCT00990340` - Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method	Phase 4
Completed	`NCT00235599` - The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.	N/A
Completed	`NCT00149708` - Consequence of Lifetime Isolated Growth Hormone Deficiency	N/A
Completed	`NCT00459940` - The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients	N/A
Completed	`NCT01157793` - 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	Phase 4
Completed	`NCT00004365` - Study of Pituitary Size and Function in Familial Dwarfism of Sindh	N/A
Recruiting	`NCT00227253` - Chromosome 18 Clinical Research Center
Recruiting	`NCT04121780` - Growth Hormone Replacement Therapy for Retried Professional Football Players	Phase 2
Completed	`NCT02934399` - Dynamic Hormone Diagnostics in Endocrine Disease
Completed	`NCT01090778` - Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)	Phase 2
Completed	`NCT00965484` - Genotropin Study Assessing Use of Injection Pen	Phase 3
Completed	`NCT01062529` - Peripheral Metabolic Effects of Somatostatin	N/A
Completed	`NCT00616278` - National Cooperative Growth Study in CKD	N/A
Completed	`NCT02693522` - Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency	Phase 3
Recruiting	`NCT02908958` - Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency	Phase 4
Terminated	`NCT01243892` - A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device	N/A
Withdrawn	`NCT00638287` - Inter-Assay Growth Hormone and IGF-I Variability	N/A
Completed	`NCT00957671` - Anterior Pituitary Hormone Replacement in Traumatic Brain Injury	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms