Effects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype (GHAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01616095|
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : April 17, 2018
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
- 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.
|Condition or disease|
|Growth Hormone Deficiency|
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|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|
|Actual Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2015|
Adults with Growth Hormone Deficiency
if multiple hormonal deficiences exist, long term adequate supplementation is provided and tightly monitored.
matched for BMI, age, and gender
- 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.
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616095
|V th Internal Clinic, Univeristy Hospital Bratislava, Comenius University|
|Bratislava, Slovakia, 82606|
|Inst. Exp. Endocrinology Slovak Acad Sci|
|Bratislava, Slovakia, 83306|
|National Institute of Endocrinology and Diabetology|
|Lubochna, Slovakia, 03491|
|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|