ECE2011 Poster Presentations Pituitary (111 abstracts)
Introduction: GH substitution in GH deficiency (GHD) must be subcutaneously administered daily. Recently, a new sustained release formulation of GH (LB03002) has been developed which has to be injected only once per week. As a sub-study to the double-blind, randomized, placebo-controlled, multicenter, phase-III-study we performed this prospective study to evaluate influences of the new GH formulation on metabolic parameters and the hormones leptin and ghrelin in adult patients with GHD.
Methods: Eleven patients with GHD (4f/7m, median age 58 years (2969 years)) without any GH therapy for at least 6 months were included in the study. Eight patients were treated with LB03002 for 12 months, three patients started with placebo for 6 months and were then switched to LB03002 for another 6 months. A 3 h oral glucose tolerance test (OGTT) was performed at study entry and at study end. Additionally, IGF1, lipid parameters including cholesterol, LDL, HDL, and triglycerides, leptin, ghrelin, HbA1c and C-peptide were measured. Body composition was evaluated by dual-energy-X-ray-absorptiometry, waist/hip (WHR) and waist/height (WHtR) ratio by tape.
Results: Multiple of upper limit of normal (xULN) of IGF1 (0.23 (0.090.4) vs 0.71 (0.41.04), P<0.01), WHR (0.98 (0.861.04) vs 1.01 (0.861.05), P<0.05) and ghrelin levels (119.8 ng/l (67.7266.6) vs 137 ng/l (67289.5), P<0.05) were significantly higher and fat mass (34.7% (20.449.2) vs 32.4% (16.748.5), P<0.05) and leptin levels (11.2 μg/l (3.355.7) vs (7.05 μg/l (2.454.3), P<0.05) were significantly lower at study end. Glucose and insulin levels during OGTT as well as insulin resistance (HOMA-IR), insulin sensitivity (ISI), β-cell function (HOMA-β), C-peptide and HbA1c were not statistically significantly different before and after GH substitution, neither were BMI, WHtR, bone-mineral-density (BMD) and lipid parameters.
Conclusion: Substitution with LB03002 showed statistically significant reduction of fat mass, which leads to reduced leptin levels and increased ghrelin levels but does not seem to influence glucose and lipid metabolism.