Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2013
The ghrelin agonist RM-131 accelerates gastric emptying of solids and reduces symptoms in patients with type 1 diabetes mellitus.
Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
52 citing papers in PubMed, 3 syntheses or guidelines pooled it, 110 citations in OpenAlex.
- Do prokinetic agents provide symptom relief through acceleration of gastric emptying? An update and revision of the existing evidence.United European gastroenterology journal · 2023Pooled it
- Efficacy and Safety of Ghrelin Agonists in Patients with Diabetic Gastroparesis: A Systematic Review and Meta-Analysis.Gut and liver · 2020Pooled it
- Pharmacological Approaches to Diabetic Gastroparesis: A systematic review of randomised clinical trials.Sultan Qaboos University medical journal · 2019Pooled it
- Trial
- GI Dysfunctions in Diabetic Gastroenteropathy, Their Relationships With Symptoms, and Effects of a GLP-1 Antagonist.The Journal of clinical endocrinology and metabolism · 2019Trial
- Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study.Gastroenterology · 2017Trial
- Relationship Between Gastric Emptying and Diurnal Glycemic Control in Type 1 Diabetes Mellitus: A Randomized Trial.The Journal of clinical endocrinology and metabolism · 2017Trial
- Effects of ghrelin receptor agonist, relamorelin, on gastric motor functions and satiation in healthy volunteers.Neurogastroenterology and motility · 2016Trial
- Short-Term Effects of Relamorelin on Descending Colon Motility in Chronic Constipation: A Randomized, Controlled Trial.Digestive diseases and sciences · 2016Trial
- Delayed Gastric Emptying Is Associated With Early and Long-term Hyperglycemia in Type 1 Diabetes Mellitus.Gastroenterology · 2015Trial
- Progress in Gastroparesis Management: From Pharmacotherapy to Interventional Treatments.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- Pharmacologic treatments for gastroparesis.Pharmacological reviews · 2025Review
- Resolution of severe gastroparesis induced by parasympathetic surge following facial trauma: a case report.Journal of medical case reports · 2024Article
- Common Pathophysiological Mechanisms and Treatment of Diabetic Gastroparesis.Journal of neurogastroenterology and motility · 2024Review
- Layer-Specific BTX-A Delivery to the Gastric Muscularis Achieves Effective Weight Control and Metabolic Improvement.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023Article
- Diabetic Gastroparesis and its Emerging Therapeutic Options: A Narrative Review of the Literature.Cureus · 2023Review
- Ten controversies in gastroparesis and a look to the future.Neurogastroenterology and motility · 2023Review
- Gastroparesis.Gastroenterology · 2022Review
- Structural basis of human ghrelin receptor signaling by ghrelin and the synthetic agonist ibutamoren.Nature communications · 2021Article
- Management of Gastroparesis.Gastroenterology & hepatology · 2021Article
Corrections and comments
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Authors and funding
9 authors at 2 institutions in 1 country.
Funding
Abstract
BACKGROUND &
aimsRM-131, a synthetic ghrelin agonist, greatly accelerates gastric emptying of solids in patients with type 2 diabetes and delayed gastric emptying (DGE). We investigated the safety and effects of a single dose of RM-131 on gastric emptying and upper gastrointestinal (GI) symptoms in patients with type 1 diabetes and previously documented DGE.
methodsIn a double-blind cross-over study, 10 patients with type 1 diabetes (age, 45.7 ± 4.4 y; body mass index, 24.1 ± 1.1 kg/m(2)) and previously documented DGE were assigned in random order to receive a single dose of RM-131 (100 μg, subcutaneously) or placebo. Thirty minutes later, they ate a radiolabeled solid-liquid meal containing EggBeaters (ConAgra Foods, Omaha, NE), and then underwent 4 hours of gastric emptying and 6 hours of colonic filling analyses by scintigraphy. Upper GI symptoms were assessed using a daily diary, gastroparesis cardinal symptom index (total GCSI-DD) and a combination of nausea, vomiting, fullness, and pain (NVFP) scores (each rated on a 0-5 scale).
resultsAt screening, participants' mean level of hemoglobin A1c was 9.1% ± 0.5%; their total GCSI-DD score was 1.66 ± 0.38 (median, 1.71), and their total NVFP score was 1.73 ± 0.39 (median, 1.9). The t1/2 of solid gastric emptying was 84.9 ± 31.6 minutes when subjects were given RM-131 and 118.7 ± 26.7 when they were given a placebo. The median difference (Δ)was 33.9 minutes (interquartile range [IQR] -12, -49), or -54.7% (IQR, -21%,-110%). RM-131 decreased gastric retention of solids at 1 hour (P = .005) and 2 hours (P = .019). Numeric differences in t1/2 for gastric emptying of liquids, solid gastric emptying lag time, and colonic filling at 6 hours were not significant. Total GCSI-DD scores were 0.79 on placebo (IQR, 0.75, 2.08) and 0.17 on RM-131 (IQR, 0.00, 0.67; P = .026); NVFP scores were lower on RM-131 (P = .041). There were no significant adverse effects.
conclusionsRM-131 significantly accelerates gastric emptying of solids and reduces upper GI symptoms in patients with type 1 diabetes and documented DGE.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.