Recombinant human growth hormone therapy in malnourished dialysis patients: A randomized controlled study

Iglesias, Pedro; Jj, Díez; Mj, Fernández-Reyes; Aguilera, Abelardo; Burgués, S; Martínez-Ara, Jorge; Miguel, J.L.; Gómez-Pan, A.; Selgas, Rafael

doi:10.1053/ajkd.1998.v32.pm9740162

Cited by 71 publications

(50 citation statements)

References 18 publications

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“…DG has been reported to be the "inactive" degradation product of AG but recent studies suggest that DG may itself have pleiotropic biologic activities, including opposing actions to AG (38)(39)(40)(41)(42)(43). In normal individuals, DG and AG levels decrease in parallel on feeding, but the ratio of DG/AG remains constant (22).…”

Section: Discussionmentioning

confidence: 99%

Association of Plasma Des-acyl Ghrelin Levels with CKD

Gupta

Kuppusamy²,

Patrie

et al. 2013

Clinical Journal of the American Society of Nephrology

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SummaryBackground and objectives There are no effective therapies for malnutrition in CKD/ESRD patients. This study hypothesized that ghrelin, an endogenous orexigenic hormone, would correlate with renal function and might suggest therapeutic interventions for CKD/ESRD malnutrition.Design, setting, participants, & measurements Fifty-one CKD and 15 hemodialysis patients were enrolled. Acyl ghrelin (AG) and des-acyl ghrelin (DG) were determined using separate two-site-specific assays. Leptin, insulin, growth hormone, insulin-link growth factor-1, C-reactive protein, TNF-a, and IL-6 were also measured.Results Univariate correlation analyses showed that CKD stage was highly, positively correlated with the levels of preprandial and postprandial DG and positively correlated with TNF-a, IL-6, leptin, and age. Multivariate partial-correlation analyses showed that CKD was independently associated with the proportion of preprandial and postprandial DG, whereas TNF-a, IL-6, leptin, insulin, and age were not independently associated with either. Geometric mean (GM) preprandial and postprandial AG were comparable between CKD stages #2 and .2, whereas GM preprandial DG and postprandial DG were 1.95-fold and 2.17-fold greater, respectively, for CKD stage .2 versus stage #2. DG was the dominant form of ghrelin preprandially and postprandially for both CKD stages #2 and .2. Dialysis had no effect on AG, but reduced DG by 73% to levels even lower (GM 48.7 pg/ml) than those seen postprandially in CKD stage #2 patients (GM 77.0 pg/ml).Conclusions This study shows a strong and independent correlation of DG with CKD stage. Postprandial suppression of ghrelin is impaired with reduced renal function. Hemodialysis selectively removes DG but not AG.

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Section: Discussionmentioning

confidence: 99%

Association of Plasma Des-acyl Ghrelin Levels with CKD

Gupta

Kuppusamy²,

Patrie

et al. 2013

Clinical Journal of the American Society of Nephrology

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“…Nevertheless, despite its evidently beneficial effects, it is uncertain whether long-term use of pharmacologic doses of GH may induce undesirable effects. In one clinical trial, GH treatment of MHD patients was associated with an initial increase in serum glucose, which reached a steady state in 2 wk (14). Another study in MHD patients did not show a significant increase in blood glucose (18).…”

Section: Safety Aspects Of Ghmentioning

confidence: 99%

“…Many reports indicate that GH injections into adult ESRD patients decrease net urea production (urea nitrogen appearance) and/or serum urea, and sometimes serum phosphorus and potassium (10,12,14,23). These findings suggest more effective utilization of protein and amino acids.…”

Section: Effects Of Gh In Normal Individuals and People With Advancedmentioning

confidence: 99%

“…Metabolic studies also indicate increased protein synthesis and more positive protein or nitrogen balance (13,22,23). Mild hyperglycemia occurred in some of these short-term studies (12,14). Longer-term interventional trials with GH lasting up to 6 mo often, but not always, showed an increase in muscle mass or lean body mass, decrease in fat mass, and new bone formation (15,16,18,19).…”

Section: Effects Of Gh In Normal Individuals and People With Advancedmentioning

confidence: 99%

“…Longer-term interventional trials with GH lasting up to 6 mo often, but not always, showed an increase in muscle mass or lean body mass, decrease in fat mass, and new bone formation (15,16,18,19). Serum albumin (11,18) or transferrin (14) rose in some trials. GH is reported to increase serum erythropoietin, leptin, IGF-I, and IGF binding protein-3, increase target organ sensitivity to parathyroid hormone and bone mineral density in GH-deficient people, and reduce serum parathyroid hormone levels (10,17,20,23,(35)(36)(37).…”

Section: Effects Of Gh In Normal Individuals and People With Advancedmentioning

confidence: 99%

See 2 more Smart Citations

Opportunity™

Kopple¹,

Cheung²,

Christiansen³

et al. 2008

Clinical Journal of the American Society of Nephrology

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Background: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health-related quality of life (HRQoL), which are significantly and positively associated with survival in MHD patients. The OPPORTUNITY TM Trial will examine whether GH reduces mortality and morbidity and improves overall health in hypoalbuminemic MHD patients.Hypothesis: The primary hypothesis is that daily recombinant human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity, and HRQoL, and has a favorable safety profile.Design/Measurements: This is a prospective, double-blind, multicenter, randomized clinical trial involving 2500 MHD patients, up to 50% with diabetes mellitus, from 22 countries. Patients are randomized in a 1:1 ratio to receive daily injections of GH (20 g/kg per day) or placebo for 104 weeks. Key inclusion criteria include clinically stable and well-dialyzed (Kt/V >1.2) adult MHD patients with serum albumin <4.0 g/dl. Exclusion criteria include active malignancy, active proliferative or severe nonproliferative diabetic retinopathy, uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy.Conclusions: The OPPORTUNITY TM Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers of body protein mass, inflammation, exercise capacity, and HRQoL.

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