Abstract
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Alimentary Pharmacology and Therapeutics |
| Vol/bind | 29 |
| Udgave nummer | 11 |
| Sider (fra-til) | 1179-87 |
| Antal sider | 8 |
| ISSN | 0269-2813 |
| DOI | |
| Status | Udgivet - 2009 |
Bibliografisk note
Keywords: Adolescent; Adult; Aged; Blood Glucose; Cross-Over Studies; Diabetes Complications; Double-Blind Method; Female; Gastric Emptying; Gastroparesis; Ghrelin; Glucose Clamp Technique; Humans; Macrocyclic Compounds; Male; Middle Aged; Treatment Outcome; Young AdultAdgang til dokumentet
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Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis. / Ejskjaer, N; Vestergaard, E T; Hellström, P M; Gormsen, L C; Madsbad, S; Madsen, J L; Jensen, T A; Pezzullo, J C; Christiansen, J S; Shaughnessy, L; Kosutic, G.
I: Alimentary Pharmacology and Therapeutics, Bind 29, Nr. 11, 2009, s. 1179-87.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
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TY - JOUR
T1 - Ghrelin receptor agonist (TZP-101) accelerates gastric emptying in adults with diabetes and symptomatic gastroparesis
AU - Ejskjaer, N
AU - Vestergaard, E T
AU - Hellström, P M
AU - Gormsen, L C
AU - Madsbad, S
AU - Madsen, J L
AU - Jensen, T A
AU - Pezzullo, J C
AU - Christiansen, J S
AU - Shaughnessy, L
AU - Kosutic, G
N1 - Keywords: Adolescent; Adult; Aged; Blood Glucose; Cross-Over Studies; Diabetes Complications; Double-Blind Method; Female; Gastric Emptying; Gastroparesis; Ghrelin; Glucose Clamp Technique; Humans; Macrocyclic Compounds; Male; Middle Aged; Treatment Outcome; Young Adult
PY - 2009
Y1 - 2009
N2 - BACKGROUND: TZP-101 is a synthetic, selective ghrelin agonist in development for gastroparesis. AIM: To assess safety and effects of TZP-101 in diabetes patients with symptomatic gastroparesis. METHODS: Adults with type 1 or type 2 diabetes mellitus received placebo and TZP-101 (80, 160, 320 or 600 microg/kg) infusions in a cross-over manner following a radiolabelled meal. Blood glucose levels were stabilized using a hyperinsulinemic-euglycemic clamp. Primary endpoints were gastric half emptying and latency times. Secondary measures included assessment of gastroparesis symptoms and endocrine responses. RESULTS: Ten patients with type 1 (n = 7) or 2 (n = 3) diabetes, moderate-to-severe gastroparesis symptoms and > or =29% retention 4 h after a radiolabelled solid meal were enrolled. TZP-101 produced significant reductions in solid meal half-emptying (20%, P = 0.043) and latency (34%, P = 0.037) times vs. placebo. Reductions in overall postmeal symptom intensity (24%) and postprandial fullness (37%) following TZP-101 infusion were not statistically significant. Most adverse events were mild and self-limiting and there were no identifiable differences in numbers or types of adverse events between TZP-101 and placebo. CONCLUSIONS: This proof-of-concept study demonstrates that the ghrelin agonist TZP-101 is well-tolerated in diabetes patients with moderate-to-severe chronic gastroparesis and shows statistically significant improvements in gastric emptying.
AB - BACKGROUND: TZP-101 is a synthetic, selective ghrelin agonist in development for gastroparesis. AIM: To assess safety and effects of TZP-101 in diabetes patients with symptomatic gastroparesis. METHODS: Adults with type 1 or type 2 diabetes mellitus received placebo and TZP-101 (80, 160, 320 or 600 microg/kg) infusions in a cross-over manner following a radiolabelled meal. Blood glucose levels were stabilized using a hyperinsulinemic-euglycemic clamp. Primary endpoints were gastric half emptying and latency times. Secondary measures included assessment of gastroparesis symptoms and endocrine responses. RESULTS: Ten patients with type 1 (n = 7) or 2 (n = 3) diabetes, moderate-to-severe gastroparesis symptoms and > or =29% retention 4 h after a radiolabelled solid meal were enrolled. TZP-101 produced significant reductions in solid meal half-emptying (20%, P = 0.043) and latency (34%, P = 0.037) times vs. placebo. Reductions in overall postmeal symptom intensity (24%) and postprandial fullness (37%) following TZP-101 infusion were not statistically significant. Most adverse events were mild and self-limiting and there were no identifiable differences in numbers or types of adverse events between TZP-101 and placebo. CONCLUSIONS: This proof-of-concept study demonstrates that the ghrelin agonist TZP-101 is well-tolerated in diabetes patients with moderate-to-severe chronic gastroparesis and shows statistically significant improvements in gastric emptying.
U2 - 10.1111/j.1365-2036.2009.03986.x
DO - 10.1111/j.1365-2036.2009.03986.x
M3 - Journal article
C2 - 19298585
VL - 29
SP - 1179
EP - 1187
JO - Alimentary Pharmacology and Therapeutics, Supplement
JF - Alimentary Pharmacology and Therapeutics, Supplement
SN - 0953-0673
IS - 11
ER -