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

NCT ID: NCT01616095

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2015-08-31

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.

Conditions

Growth Hormone Deficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adults with Growth Hormone Deficiency

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

No interventions assigned to this group

Healthy Controls

matched for BMI, age, and gender

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PFIZER, Bratislava, Slovakia

UNKNOWN

Sponsor Role: collaborator

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jozef Ukropec

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jozef Ukropec, PhD

Role: PRINCIPAL_INVESTIGATOR

Inst. Exp. Endocrinology SAS, Bratislava, Slovakia

Barbara Ukropcova, MD, PhD

Role: STUDY_CHAIR

Inst. Exp. Endocrinology SAS, Bratislava, Slovakia

Iwar Klimes, prof, MD, PhD

Role: STUDY_DIRECTOR

Inst. Exp. Endocrinology SAS, Bratislava, Slovakia

Daniela Gasperikova, PhD

Role: STUDY_CHAIR

Inst. Exp. Endocrinology SAS, Bratislava, Slovakia

Juraj Payer, prof, MD, PhD

Role: STUDY_CHAIR

Dep. of Endocrinology, University Hospital, Comenius University, Bratislava

Martin Kuzma, MD

Role: STUDY_CHAIR

Dep. of Endocrinology, University Hospital, Comenius University, Bratislava

Mikulas Pura, MD, PhD

Role: STUDY_CHAIR

National Institute of Diabetology and Endocrinology, Lubochna, Slovakia

Peter Vanuga, MD, PhD

Role: STUDY_CHAIR

National Institute of Diabetology and Endocrinology, Lubochna, Slovakia

Miroslav Vlcek, MD, PhD

Role: STUDY_CHAIR

Inst Exp. Endocirnology SAS, Bratislava

Adela Penesova, MD, PhD

Role: STUDY_CHAIR

Inst Exp. Endocirnology SAS, Bratislava

Miroslav Balaz, Mgr.

Role: STUDY_CHAIR

Inst Exp. Endocirnology SAS, Bratislava

Timea Kurdiova, Mgr.

Role: STUDY_CHAIR

Inst Exp. Endocirnology SAS, Bratislava

Locations

V th Internal Clinic, Univeristy Hospital Bratislava, Comenius University

Bratislava, , Slovakia

Inst. Exp. Endocrinology Slovak Acad Sci

Bratislava, , Slovakia

National Institute of Endocrinology and Diabetology

Ľubochňa, , Slovakia

Countries

Slovakia

References

Ukropec J, Penesova A, Skopkova M, Pura M, Vlcek M, Radikova Z, Imrich R, Ukropcova B, Tajtakova M, Koska J, Zorad S, Belan V, Vanuga P, Payer J, Eckel J, Klimes I, Gasperikova 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.

Reference Type: BACKGROUND

PMID: 18334583 (View on PubMed)

Related Links

http://www.endo.sav.sk/

link to the website of the Institute of Experimental Endocrinology Slovak Academy of Sciences

Other Identifiers

GH GIIR - 2011

Identifier Type: -

Identifier Source: org_study_id