Abstract
ObjectiveUse of growth hormone is associated with side effects, including insulin resistance. The objective of this study was to determine whether tesamorelin, a stabilized growth hormone-releasing hormone analogue, would alter insulin sensitivity or control of diabetes.DesignA 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three treatment groups: placebo, 1 and 2 mg tesamorelin.MeasurementsFasting glucose, glucose and insulin from oral glucose tolerance test, glycosylated hemoglobin (HbA1c), home blood glucose, insulin-like growth factor-1, and lipids.Main outcome measureRelative insulin response following oral ingestion of glucose.ResultsNo significant differences were observed between groups in relative insulin response over the 12-week treatment period. At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups. In addition, relevant modifications in diabetes medications were similar between groups. Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p<0.05 vs. placebo). No patient discontinued the study due to loss of diabetes control.ConclusionsTreatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin response or glycemic control.Trial registrationClinicalTrials.gov NCT01264497.
Highlights
Recombinant human growth hormone replacement therapy has been shown to reverse several metabolic alterations associated with low serum GH level or GH deficiency, including increased visceral adipose tissue (VAT), altered lipid profile, and impaired physical performance [1,2,3]
Strategies using growth hormone-releasing factor (GRF)/growth hormone-releasing hormone (GHRH) analogues to induce physiological increases of GH and preserve the insulin-like growth factor-1 (IGF-1) negative feedback have been shown to correct metabolic abnormalities and body composition changes associated with low GH levels with fewer side effects, with regard to hyperglycemia [5,6,7,8]
Of fifty five (55) patients assessed for eligibility, 53 received at least one dose of study treatment and were included in the analyses (16 patients randomized to placebo, to tesamorelin 1 mg, and to tesamorelin 2 mg)
Summary
Recombinant human growth hormone (rhGH) replacement therapy has been shown to reverse several metabolic alterations associated with low serum GH level or GH deficiency, including increased visceral adipose tissue (VAT), altered lipid profile, and impaired physical performance [1,2,3]. Administration of pharmacological doses of rhGH is associated with a variety of adverse effects, including hyperglycemia, insulin resistance, fluid retention, and carpal tunnel syndrome [3,4]. Strategies using growth hormone-releasing factor (GRF)/growth hormone-releasing hormone (GHRH) analogues to induce physiological increases of GH and preserve the insulin-like growth factor-1 (IGF-1) negative feedback have been shown to correct metabolic abnormalities and body composition changes associated with low GH levels with fewer side effects, with regard to hyperglycemia [5,6,7,8]. Because GH has been shown to worsen glucose tolerance in some subjects, including those receiving highly active antiretroviral therapy (HAART) [11], a randomized, parallel, placebo-controlled, multicenter study was carried out to assess the safety of tesamorelin in only subjects with type 2 diabetes mellitus
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