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Growth Hormone Deficiency clinical trials

View clinical trials related to Growth Hormone Deficiency.

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NCT ID: NCT01616095 Completed - Clinical trials for Growth Hormone Deficiency

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

GHAT
Start date: April 2011
Phase:
Study type: Observational

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.

NCT ID: NCT01613573 Completed - Clinical trials for Growth Hormone Deficiency

Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children

Phase 1
Start date: March 2010
Phase: Phase 1
Study type: Interventional

The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.

NCT ID: NCT01605331 Completed - Clinical trials for Growth Hormone Deficiency

Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)

Start date: December 2009
Phase: Phase 4
Study type: Interventional

As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).

NCT ID: NCT01576861 Completed - Clinical trials for Chronic Heart Failure

Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

Start date: January 2007
Phase: Phase 2
Study type: Interventional

After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.

NCT ID: NCT01495468 Completed - Clinical trials for Growth Hormone Deficiency

Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation). All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study. Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

NCT ID: NCT01467193 Completed - Insulin Sensitivity Clinical Trials

The Effect of Dietary Fat Load and Physical Exercise on the Flexibility and Partitioning of Ectopic Lipids.

Start date: August 2011
Phase:
Study type: Observational

This study aims at assessing the effect of standardized dietary fat load and short-term aerobic exercise on systemic lipolysis, flexibility and partitioning of ectopic fat stores (intramyocellular = IMCL, intrahepatocellular = IHCL, intramyocardial lipids = IMCaL) in relation to FFA in endurance trained athletes and hypopituitary patients compared to sedentary healthy control subjects. Exercise is a powerful stimulation for growth hormone (GH) secretion in health. A standardised exercise test can, therefore, be discriminative for the diagnosis of GH-deficiency in adults. This will be assessed. Hypothesis (ectopic fat stores) 1. Ectopic fats stores are flexible fuel stores and are influenced by diet and physical activity.FFA availability may play an important regulatory role. 2. There is a tissue specific partitioning of triglycerides and/or FFA among non-adipose organs after fat load and physical exercise 3. The flexibility of ectopic fat stores is related to insulin sensitivity 4. Lipolytic and anti-lipolytic hormones are critical for regulating FFA availability (at rest or during exercise) and therefore also for the regulation of ectopic fat stores. 5. GH is a lipolytica hormone. Lack of GH in adulthood is related to decreased FFA availability thereby influencing ectopic lipid stores Hypothesis diagnosis of GHD 6. A short intensive physical exercise shows a good discriminative power to diagnose GHD.

NCT ID: NCT01440686 Completed - Clinical trials for Growth Hormone Deficiency

Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers

HL-032
Start date: September 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of HL-032 after oral administration in healthy male volunteers.

NCT ID: NCT01365351 Completed - Clinical trials for Growth Hormone Deficiency

Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

Start date: December 1, 2007
Phase: N/A
Study type: Observational

The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.

NCT ID: NCT01359488 Completed - Clinical trials for Growth Hormone Deficiency

VRS-317 in Adult Subjects With Growth Hormone Deficiency

Start date: March 2011
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to determine the safety and tolerability of up to five doses of VRS-317 in Adult Growth Hormone Deficient patients. - Patients will be evaluated for evidence of activity of VRS-317 by measurement of changes from baseline in insulin-like growth factor-1 (IGF-I) and binding protein (IGFBP-3), and bone turnover (bone alkaline phosphatase) - Descriptive pharmacokinetic (PK) and pharmacodynamic (PD) parameters (IGF-I and IGFBP-3) will be determined by standard model independent methods based on the plasma concentration-time data of each subject. These parameters include: Cmax, Tmax, AUCavg, AUC0-inf, and t1/2. - The purpose is to determine the appropriate dose of VRS-317 to maintain a normal range (for appropriate age/gender) for IGF-I levels in adult patients for up to one month after administration of a single dose

NCT ID: NCT01351818 Completed - Clinical trials for Growth Hormone Deficiency

Adipocyte Function and Somtropin Deficiency

FAYDS
Start date: May 2005
Phase: N/A
Study type: Observational

To assess the influence of exogenous GH (growth hormone) administration on adipocyte endocrine function (leptin, adiponectin, and resistin) and on ghrelin secretion in children with delayed growth due to GH deficiency. Study hypothesis: hormones produced by the adipocyte (leptin, adiponectin, and resistin) and ghrelin may exert a certain control on production of GH and IGF-I, and GH may in turn have a regulatory effect on such hormones.