Solid Test Meal Research Articles

When symptoms are more than reflux.

45 year-old male patient with history of heartburn and regurgitation of non-acid food in the immediate postprandial period, with no symptomatic improvement after anti-acid treatment. The patient underwent an upper endoscopy that was unremarkable. A high-resolution impedance manometry (HRIM) was performed according to Chicago Protocol 4.0, as well as an additional solid test meal, with findings of rumination syndrome (RS) (figure 1). The study was completed with a 24-hour impedance pH monitoring that showed, in the immediate postprandial period, episodes of reflux that reached the proximal sensor followed by a normal swallow (figure 2). Abdominophrenic biofeedback was started with clinical improvement and anti-acid treatment was maintained at once a day. Discussion: RS is diagnosed by a complete clinical history, using the Rome IV or DSM-5 criteria (figure 3). Due to lack of knowledge of the disease and the fact that regurgitation can be present in other conditions including gastroesophageal reflux disease and achalasia, most patients undergo multiple tests and visit several physicians before reaching the diagnosis1. The gold standard investigation for RS, in cases where there are diagnostic doubts, is HRIM with solid meal administration, that shows a sudden increase in intragastric pressure > 30 mmHg concurrent with a drop in impedance and both simultaneous lower and upper esophageal sphincter relaxation, that may or may not be followed by re-swallowing food2. Rumination episodes can appear spontaneously (type 1) or may be preceded by a reflux episode (type 2) or a supragastric belch (type 3)3. 24-hour impedance pH monitoring cannot confirm de diagnosis, but during rumination, in the majority of episodes, the refluxed material reaches the proximal esophagus2.

Clinical utility of the solid meal test during high-resolution esophageal manometry. A study in a Latin American population

Introduction and aimsThe solid test meal (STM) is a challenge test that is done during esophageal manometry and appears to increase the diagnostic yield of the study. The aim of our analysis was to establish the normal values for STM and evaluate its clinical utility in a group of Latin American patients with esophageal disorders versus healthy controls. Material and methodsA cross-sectional study was conducted on a group of healthy controls and consecutive patients that underwent high-resolution esophageal manometry, in which STM was done at the final part of the study and consisted of asking the subjects to eat 200 g of precooked rice. The results were compared during the conventional protocol and the STM. ResultsTwenty-five controls and 93 patients were evaluated. The majority of the controls (92%) completed the test in under 8 min. The STM changed the manometric diagnosis in 38% of the cases. The STM diagnosed 21% more major motor disorders than the conventional protocol; it doubled the cases of esophageal spasm and quadrupled the cases of jackhammer esophagus, whereas it demonstrated normal esophageal peristalsis in 43% of the cases with a previous diagnosis of ineffective esophageal motility. ConclusionsOur study confirms the fact that complementary STM during esophageal manometry adds information and enables a more physiologic assessment of esophageal motor function to be made, compared with liquid swallows, in patients with esophageal motor disorders.

Utilidad clínica de la prueba de comida sólida durante la realización de manometría esofágica de alta resolución. Un estudio en población latinoamericana

Introduction and aimsThe solid test meal (STM) is a challenge test that is done during esophageal manometry and appears to increase the diagnostic yield of the study. The aim of our analysis was to establish the normal values for STM and evaluate its clinical utility in a group of Latin American patients with esophageal disorders versus healthy controls. Material and methodsA cross-sectional study was conducted on a group of healthy controls and consecutive patients that underwent high-resolution esophageal manometry, in which STM was done at the final part of the study and consisted of asking the subjects to eat 200g of precooked rice. The results were compared during the conventional protocol and the STM. ResultsTwenty-five controls and 93 patients were evaluated. The majority of the controls (92%) completed the test in under 8min. The STM changed the manometric diagnosis in 38% of the cases. The STM diagnosed 21% more major motor disorders than the conventional protocol; it doubled the cases of esophageal spasm and quadrupled the cases of jackhammer esophagus, whereas it demonstrated normal esophageal peristalsis in 43% of the cases with a previous diagnosis of ineffective esophageal motility. ConclusionsOur study confirms the fact that complementary STM during esophageal manometry adds information and enables a more physiologic assessment of esophageal motor function to be made, compared with liquid swallows, in patients with esophageal motor disorders.

How provocative tests in addition to wet swallows during high-resolution manometry can direct clinical management.

Provocative tests have been advocated to address limitations of high-resolution manometry (HRM) with wet swallows. We describe the commonly used provocative manometric manoeuvres [rapid drink challenge (RDC), multiple rapid swallows (MRS), solid swallows and the solid test meal (STM)], compare their diagnostic yield and accuracy to wet swallows, and outline their role in directing clinical management. Provocative testing with RDC and STM identifies a proportion of achalasia cases missed by standard testing, and RDC can play a similar role to radiology in the evaluation of treatment response. In EGJOO, provocative testing with RDC and STM not only increase the diagnostic yield, but can also help differentiate between spurious cases and those representing true outflow obstruction likely to respond to achalasia-type therapies. MRS and STM can help determine the clinical relevance (or otherwise) of ineffective oesophageal motility, and in this setting, MRS may predict the likelihood of postfundoplication dysphagia. RDC and STM can help identify cases of postfundoplication dysphagia more likely to respond to dilatation. Provocative testing has been shown to increase diagnostic yield of HRM, clarify inconclusive diagnoses, allows corroboration of dysmotility with patient symptoms and helps direct clinical management.

Effect of liquid and solid test meals on symptoms and gastric myoelectrical activity in patients with gastroparesis and functional dyspepsia.

Patients with gastroparesis (GP) and functional dyspepsia (FD) have similar symptoms, but the pathophysiology of postprandial symptoms remains uncertain. To compare symptoms and gastric myoelectrical activity (GMA) after liquid and solid test meals in patients with GP and FD. Patients enrolled in the Gastroparesis Clinical Research Consortium Registry were studied. Clinical characteristics were measured with standard questionnaires. GP was determined by 4-h solid-phase gastric scintigraphy. GMA was measured using electrogastrography before and after ingestion of a water load or nutrient bar on separate days. Symptoms were measured on visual analog scales. GMA responses to the water load for individual patients were also determined. 284 patients with GP and 113 with FD were identified who ingested both test meals. Patients with GP and FD had similar maximal tolerated volumes of water [mean (SD) 378 (218) ml vs. 402 (226) ml, p=0.23] and reported similar intensity of fullness, nausea, bloating, and abdominal discomfort after the test meals. Twenty-six percent and 19% of the patients with GP and FD, respectively, ingested subthreshold (<238ml) volumes of water (p=0.15). Gastric dysrhythmias were recorded in 66% of the GP and 65% of the FD patients after the water load. Symptoms and GMA were similar in both groups after ingestion of the nutrient bar. The similarity in GMA responses and symptoms after ingestion of solid or liquid test meals suggests GP and FD are closely related gastric neuromuscular disorders.

Chicago classification version 4.0© technical review: Update on standard high-resolution manometry protocol for the assessment of esophageal motility.

The Chicago Classification v4.0 (CCv4.0) is the updated classification scheme for esophageal motility disorders using metrics from high-resolution manometry (HRM). A key feature of CCv.4.0 is the more rigorous and expansive protocol that incorporates single wet swallows acquired in different positions (supine, upright) and provocative testing, including multiple rapid swallows and rapid drink challenge. Additionally, solid bolus swallows, solid test meal, and/or pharmacologic provocation can be used to identify clinically relevant motility disorders and other conditions (eg, rumination) that occur during and after meals. The acquisition and analysis for performing these tests and the evidence supporting their inclusion in the Chicago Classification protocol is detailed in this technical review. Provocative tests are designed to increase the diagnostic sensitivity and specificity of HRM studies for disorders of esophageal motility. These changes attempt to minimize ambiguity in prior iterations of Chicago Classification, decrease the proportion of HRM studies that deliver inconclusive diagnoses and increase the number of patients with a clinically relevant diagnosis that can direct effective therapy. Another aim in establishing a standard manometry protocol for motility laboratories around the world is to facilitate procedural consistency, improve diagnostic reliability, and promote collaborative research.

Solid Swallow Examination During High Resolution Manometry and EGJ-Distensibility Help Identify Esophageal Outflow Obstruction in Non-obstructive Dysphagia

Single water swallow (SWS) high-resolution manometry (HRM) may miss relevant esophageal motility disorders. Solid test meal (STM) during HRM and lately the functional lumen imaging probe (FLIP) have been shown to be of diagnostic value in the assessment of motility disorders. We aimed to assess the diagnostic yield of STM and FLIP in non-obstructive dysphagia (NOD). Patients assessed for dysphagia with both HRM and FLIP between April 2016 and August 2019 were analyzed for signs of non-obstructive EGJ outflow obstruction (EGJOO) according to Chicago Classification 3.0 (CCv3) and CC adapted for the use with solid swallows (CC-S), followed by an individual group-specific analysis. Five subjects without dysphagia served as control group. Standard HRM- and FLIP-values as well as esophagograms and Eckardt Scores were analyzed. Forty-two patients were identified (male/female, 14/36, median age 62). Twenty-five (59.5%) were diagnosed with EGJOO during STM only (= SWS-negative patients; CC-S). The EGJ distensibility index (EGJ-DI) of symptomatic patients was significantly lower compared to the control group (p = 0.006). EGJ-DI was < 3mm2/mmHg in 67% and 88% of patients diagnosed according to CC-S and CCv3, respectively. The IRP during STM showed a significant association to the corresponding EGJ-DI values (p < 0.001). Seventy-six percent of patients received treatment because of additional STM evaluation with a favorable clinical response rate of 89%. STM and FLIP identify EGJOO in symptomatic patients with normal SWS during HRM. STM resembles an inexpensive and clinically meaningful option to diagnose motility disorders and helps to select patients for interventional treatment.

Changes in Ghrelin and Glucagon following a Low Glycemic Load Diet in Women with PCOS.

Altered satiety hormones in women with polycystic ovarian syndrome (PCOS) may contribute to obesity. Diets with a low glycemic load (GL) may influence appetite-regulating hormones including glucagon and ghrelin. To test the hypothesis that following a 4-week, eucaloric low vs high GL diet habituation, a low vs high GL meal will increase glucagon and decrease ghrelin to reflect greater satiety and improve self-reported fullness. Secondary analysis of a randomized crossover trial. Thirty women diagnosed with PCOS. Participants were provided low (41:19:40% energy from carbohydrate:protein:fat) and high (55:18:27) GL diets for 8 weeks each. At each diet midpoint, a solid meal test was administered to examine postprandial ghrelin, glucagon, glucose, insulin, and self-reported appetite scores. After 4 weeks, fasting glucagon was greater with the low vs high GL diet (P = .035), and higher fasting glucagon was associated with lesser feelings of hunger (P = .009). Significant diet effects indicate 4-hour glucagon was higher (P < .001) and ghrelin was lower (P = .009) after the low vs high GL meal. A trending time × diet interaction (P = .077) indicates feelings of fullness were greater in the early postprandial phase after the high GL meal, but no differences were observed the late postprandial phase. These findings suggest after low GL diet habituation, a low GL meal reduces ghrelin and increases glucagon in women with PCOS. Further research is needed to determine the influence of diet composition on ad libitum intake in women with PCOS.

Resistance of postprandial gastric functions and autonomic balance to taste stimulation.

Exposure to unpleasant tastes leads to disturbances of interdigestive gastric myoelectrical activity (GMA) and may affect sympathetic/parasympathetic balance (SPB). We made a careful study to determine whether taste stimulation modulates the postprandial GMA, SPB, and gastric emptying (GE) of a solid meal. Eighteen healthy volunteers (9F/9M) entered the study. On six separate days, we recorded a four-channel electrogastrogram from each volunteer during a 35-min fasting period, then for 90 min after ingestion of a solid test meal of 300 kcal. GE was measured using a 13C-octanoic acid breath test. Heart rate variability (HRV) analysis was simultaneously performed. At the start of the 21st min after the test meal, subjects received an agar cube delivering either a sweet, salty, sour, or bitter taste, which they kept in the mouth for 35 min. Control procedures involved sessions performed with a tasteless agar cube, and without any stimulation. There was no effect of the experimental intervention upon the relative power share of particular GMA rhythms. Stimulation with the salty and the bitter taste evoked a statistically significant increase in the dominant frequency, whereas the sweet and sour taste did not affect it. Taste stimulation did not interfere with the meal-induced rise in the dominant power, nor affect slow wave coupling. The kinetics of the solid GE remained unchanged by the intervention. None of the taste stimulations affected the postprandial SPB. Taste stimulation elicited after ingestion of a meal, in contrast to that during a fast, did not adversely modify the postprandial pattern of either the GMA or SPB, nor affect the GE of solids.

A Novel Method for Time-Dependent Numerical Modeling of Gastric Motility Directly from Magnetic Resonance Imaging.

Gastric motility has a critical role in disintegration and mixing of the ingested food inside the stomach. Several studies have been conducted to quantify and analyze the effect of the contractions of gastric musculature on the stomach contents. Despite the anatomical variation in stomach shape and motility patterns, previous numerical studies employed generalized geometries of the stomach as the computational domain for simulations. To model realistic gastric muscular contractions, the variation in stomach geometries need to be accounted for in numerical simulations. In the current study, a novel method was developed to utilize the recent advances in magnetic resonance imaging (MRI) technology and computational power expansion to build anatomically and physiologically realistic subject specific models of human gastric motility. In this method, MRI scans of the stomach were used to construct two and three dimensional geometry models of gastric motility. MRI was performed on 4 healthy participants. Using the developed method, dynamic numerical geometry models of gastric motility for each participant were constructed and related geometrical calculations were presented. Different combinations of solid and liquid test meals were consumed prior to the scans. The volume of the stomach ranged between 0.36 - 1.10 L in the fed state. The stomach models had an average length of 184 to 226 mm and a maximum diameter of 65 to 102 mm. Contraction propagation speed calculated from the models and MRI data were in good agreement, measuring around 2 mm/s.Clinical relevance- Clinicians can benefit from the proposed method for diagnostic purposes as the method is semi-automatic and can provide dynamic three-dimensional visualization of gastric motility of patients.

1018-P: Comparison of Short- and Long-Acting Glucagon-Like Peptide-1 Receptor Agonist Effects on Postprandial Glucose and Lipid Excursion via Gastric Emptying

Background: It has been suggested that short- and long-acting glucagon-like peptide 1 receptor agonists (GLP-1RAs) exert different actions on gastric emptying rate (GE). However, the alterations in gastric emptying and their contributions to postprandial glucose and lipid excursions have not been fully evaluated. Methods: A 3-arm non-randomized trial was conducted in Japanese patients with type 2 diabetes. Meal tolerance test was performed before and 12 weeks after initiation of treatment by short-acting GLP-1RA (Lixisenatide (X)) or long-acting GLP-1RA [Liraglutide (R) or Dulaglutide(D)]. Plasma glucose, ApoB48, insulin and gastric emptying (13C breath test) were measured after taking a solid test meal. Data were presented as average±SD and evaluated using student’s or paired t-test. p&amp;lt;0.05 was considered significant. Results: 18 patients were enrolled [X: n=7; age(year) 45.6±2.3; duration(year) 4.6±5.0; ΔCPR(glucagon stimulation test (mg/dl) 3.2±1.4, R: n=6; age 49.0±11.4; duration 8.2±9.2; ΔCPR 3.1±0.5, D; n=5; age 51.8±7.6; duration 4.6±3.8; ΔCPR 2.7±1.3)]. After 12 weeks administration, HbA1c was significantly improved in all groups [HbA1c (%), X: 8.2±1.6 to 6.3±0.4, L: 9.0±0.8 to 6.6±1.1, D: 8.6±0.9 to 6.6±0.3]. GE was delayed only in X [T1/2(min), X: 26.4±6.5 to 64.4±34.4, L: 33.5±15.5 to 29.1±9.2, and D: 26.3±3.8 to 31.1±9.7]. Postprandial insulin and ApoB48 secretion was significantly decreased only in X [IRI-AUC0-240(uIU/dlxmin), X: 11724.0±5582.0 to 6248.2±3718.7, L: 8206.7±3075.4 to 9905.0±3450.3, D: 9832.8±5087.3 to 10640.6±4195.1 and ApoB48-iAUC0-240(ug/mlxmin), X: 513.2±394.4 to -83.7±242.6; L: 745.1±352.4 to 534.1±193.4; and D: 983.5±239.0 to 568.2±374.4]. Conclusion: These results indicate that short-acting agents improve postprandial glycemic and lipidemic metabolism through delaying GE; long-acting agents improve glycemic control through enhanced insulin secretion. Disclosure H. Kuwata: Research Support; Self; Eli Lilly and Company. D. Yabe: Advisory Panel; Self; Abbott. Research Support; Self; Astellas Pharma Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited. Y. Hamamoto: Speaker's Bureau; Self; Novo Nordisk A/S. T. Kurose: Consultant; Self; Taisho Pharmaceutical Co., Ltd. Speaker's Bureau; Self; FujiFilm Pharma, Ono Pharmaceutical Co., Ltd. Y. Seino: Research Support; Self; Arkray, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck &amp; Co., Inc., Novo Nordisk Inc., Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Company Limited, Terumo Medical Corporation.

Tu1235 – Clinical Utility of High-Resolution Esophageal Manometry with a Solid Test Meal. A Cross Sectional Study of Healthy Controls and Patients

Tu1235 – Clinical Utility of High-Resolution Esophageal Manometry with a Solid Test Meal. A Cross Sectional Study of Healthy Controls and Patients

Tu1236 – Pathophysiological Mechanisms Associated with Supragastric Belching. an Evaluation with Esophageal High-Resolution Manometry with a Solid Test Meal

Tu1236 – Pathophysiological Mechanisms Associated with Supragastric Belching. an Evaluation with Esophageal High-Resolution Manometry with a Solid Test Meal

Interpretation und performance of high-resolution esophageal manometry: Recommendations of the German Association of Neurogastroenterology and Motility (DGNM) and the German Association of Gastroenterology, Digestive and Metabolic Diseases (DGVS)

Esophageal manometry provides a detailed evaluation of esophageal contractility and, therefore, represents the reference method for diagnosis of esophageal motility disorders. Significance and clinical relevance have been further increased by implementation of high-resolution esophageal manometry (HRM), which reveals the functional anatomy of the esophagus in a visually-intuitive manner. The current 3 rd version of the international Chicago Classification (CC v3.0) gives standardized recommendations on performance and interpretation of HRM and serves as the basis for much of this expert consensus document. However, CC v3.0 gives only limited information with regards to the function of the lower and upper esophageal sphincters, the use of adjunctive tests including solid test meals and long-term ambulatory HRM measurements. In this expert consensus, we describe how to perform and interpret HRM on the basis of the CC v3.0 with additional recommendations based on the results of recent, high-quality clinical studies concerning the use of this technology to assess the causes of esophageal symptoms in a variety of clinical scenarios.

Abnormal esophageal motility during a solid test meal in systemic sclerosis-detection even in very early disease and association with disease progression.

This study assessed whether high-resolution manometry (HRM) with a test meal can detect clinically relevant, abnormal motility already in very early systemic sclerosis (SSc) and whether this finding is associated with subsequent disease progression. This prospective, longitudinal cohort study recruited 68 consecutive SSc patients (group #1: 32 established disease (ACR, American College of Rheumatology /EULAR, The European League against Rheumatism 2013 and ACR 1980 criteria fulfilled); group #2: 24 early disease (only ACR/EULAR 2013 fulfilled); group #3: 12 very early disease (clinical expert diagnosis of SSc) and 72 healthy controls. HRM evaluated esophageal motility for water swallows and a solid test meal. Systemic sclerosis patients had less frequent effective esophageal contractions during the test meal compared to healthy controls even in very early disease (0.15, 1.0, 2.1 per minute for groups #1, #2, and #3, vs 2.5 per minute in health; P<0.001, P<0.001, and P<0.0085, respectively). Ineffective motility at HRM was associated with a higher modified Rodnan skin score at baseline. Moreover, at mean 18 (10-31) months of follow-up, the presence of ineffective motility at baseline was associated with progression of skin disease (P=0.01). Cox proportional hazard regression analysis identified hypotensive peristalsis in the test meal (<15% effective solid swallows) and low distal contractile integral (DCI; <400 mm Hg·cm·s) as predictors for skin aggravation, but not for new organ involvement. Ineffective motility during a test meal is present already in patients with very early SSc. Findings on HRM studies are associated with disease severity at baseline, and low percentage of effective swallows in test meal and low mean DCI are both predictors of skin progression during follow-up.

Idiopathic Dumping Syndrome in Patients Presenting with Chronic Unexplained Nausea

Introduction: Dumping syndrome is a well—known complication after gastric surgery. However, limited literature exists on idiopathic dumping syndrome. Our aim is to investigate the clinical characteristics of non—surgical patients with rapid gastric emptying who present with unexplained chronic nausea. Methods: A retrospective study was conducted on patients who had severe rapid gastric emptying, defined as gastric retention <30% at one hour during a four—hour isotope—labeled solid meal test. These patients were identified by chart review and were seen in a Neurogastroenterology Clinic at an academic institution between January 2011 and December 2017 for nausea and other unexplained gastrointestinal symptoms. Results: Forty—six patients were identified with severe rapid gastric emptying; sixteen were excluded due to previous gastric surgeries. The remaining thirty non—surgical patients (50% females, mean age 49 years, mean BMI 28) had a mean gastric retention of 19% (range 2% to 30%) at one hour. Thirteen (43%) had diabetes, and nine (30%) were insulin dependent. Six patients (20%) had a previous diagnosis of gastroparesis. All patients presented with unexplained nausea, fifteen (50%) had early satiety, and fifteen (50%) had bloating. Variations in bowel habits were reported as follows: 26% with diarrhea, 27% with constipation, 10% with diarrhea and constipation, and 27% with normal bowel movements. Sixteen (53%) patients had electrogastrogram tests: 69% had poor water load satiety test (ingested <557 mL in five min), 13% had tachygastria, 25% had bradygastria, 19% had mixed tachygastria and bradygastria, and 44% were normal. Five patients (17%) had positive breath tests for small bowel bacterial overgrowth. Conclusion: 1. Patients with severe idiopathic rapid gastric emptying may present with nausea and gastroparesis—like symptoms rather than vasomotor symptoms and diarrhea typically seen in postsurgical dumping syndrome; 2. Over half of the patients had risk factors for abnormal gastric motility, such as diabetes, poor water load satiety tests, and gastric dysrhythmias, which may contribute to altered emptying rates; 3. Physiological mechanisms underlying rapid gastric emptying warrants further investigations; and 4. Rapid gastric emptying should be considered in patients who present with chronic unexplained nausea without previous gastric surgeries.

Esophageal motility disorders

Esophageal symptoms are most often related to gastroesophageal reflux disease and other mucosal or structural processes in the tubular esophagus. When these have been appropriately ruled out with careful endoscopy, or when motility disorders are suspected based on persistent symptoms or endoscopic findings, esophageal motility testing is performed. High resolution manometry has been shown to be superior and has largely replaced conventional esophageal manometry, as it provides more detailed evaluation of esophageal motor function and results in an accurate diagnosis more often. Using innovative and intuitive software tools applied to the electronic pressure data from high resolution manometry, esophageal outflow obstruction (including achalasia spectrum disorders), major motor disorders (hypercontractile esophagus, distal esophageal spasm, and absent contractility), and minor disorders (ineffective esophageal motility and fragmented peristalsis) can be diagnosed. Provocative testing (multiple rapid swallows, rapid drink challenge, and solid test meal) can provide additional gain in motor diagnoses in symptomatic patients with normal or inconclusive standard manometry, but the clinical value is still controversial. New metrics have been introduced to characterize the esophagogastric junction in terms of barrier function and morphology, which are relevant in the context of gastroesophageal reflux disease. Barium radiography has a complementary role in the evaluation and follow-up in patients with symptoms suggestive of esophageal motility disorders. Symptomatic patients with minor motor disorders or normal motility, especially when response to provocative testing is normal, may have a functional basis for symptoms.

Better Postprandial Glucose (PPG) Control with BioChaperone Combo (BC Combo) than with Lispro Mix25 (LMx) or Separate Glargine and Lispro (G+L) Administrations in Subjects with Type 2 Diabetes (T2DM)

BC Combo is a co-formulation of prandial insulin lispro (25%) and basal insulin glargine (75%) with a rapid “prandial“ insulin component and prolonged flat “basal“ component compared to LMx. In this study the effects of BC Combo on PPG vs. LMx and G+L were investigated. Thirty-nine T2DM subjects (mean±SD age 60.8±7.5 years and HbA1c 7.97±0.6%) were randomized to receive the three insulin combinations immediately before a standardized solid meal test (MMT, 20% protein 30% fat 50% carbohydrates) in a double-blind, double-dummy, cross-over design. The individual insulin dose was the same for each visit day (mean 0.62 U/kg). BC Combo demonstrated improved PPG compared to LMx (Figure, reduction ∆AUCBG,0-2h of 18%, p=0.0009) and G+L (reduction ∆AUCBG,0-2h of 10%, p=0.0450). The proportion of subjects experiencing documented symptomatic hypoglycemic events (plasma glucose &amp;lt;70 mg/mL) over 24h was numerically lower with BC Combo (15.8%) vs. LMx (32.4%) and G+L (21.6%). The total insulin PK profile of BC Combo showed a faster time to insulin peak and a lower exposure in the late prandial phase (2-6 h) than LMx and G+L. In conclusion, BC Combo demonstrated superior PPG control in T2DM subjects with numerically fewer subjects experiencing symptomatic hypoglycemia compared to both LMx and separate G+L. Disclosure T. Heise: Research Support; Self; ADOCIA, Boehringer Ingelheim GmbH, Dance Biopharm, Eli Lilly and Company, Janssen Research &amp; Development, MedImmune, Merck Sharp &amp; Dohme Corp., Mylan, Nordic Bioscience, Novo Nordisk A/S, Poxel SA, Roche Diagnostics Corporation, Saniona, Sanofi, Senseonics, Zealand Pharma A/S. Advisory Panel; Self; Novo Nordisk A/S, Mylan. Speaker's Bureau; Self; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk A/S, Sanofi. L. Plum-Moerschel: None. C. Mégret: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. T. Herbrand: None. V. Vacher: Employee; Self; ADOCIA. E. Anastassiadis: None. O. Klein: None. M. Gaudier: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. O. Soula: Board Member; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA. Employee; Spouse/Partner; ADOCIA. S. Glezer: Stock/Shareholder; Self; Sanofi. Stock/Shareholder; Spouse/Partner; Sanofi. Employee; Self; ADOCIA, Novo Nordisk Inc.. Employee; Spouse/Partner; Pfizer Inc., Teva Pharmaceutical Industries Ltd.. Stock/Shareholder; Spouse/Partner; Teva Pharmaceutical Industries Ltd.. B. Alluis: None. G. Meiffren: Employee; Self; ADOCIA. Stock/Shareholder; Self; ADOCIA.

Glass half empty? Lessons learned about gastroparesis.

Gastroparesis is defined as a combination of chronic dyspeptic symptoms and delayed emptying of a solid test meal. It remains a difficult-to-treat disorder with a significant impact on quality of life. Although gastroparesis is defined by delayed emptying, several important studies did not find a correlation between this biomarker and symptom severity or treatment success. Thus, some of the more recent trials explored strategies that ranged from antiemetics to antidepressants. Although dietary management showed benefit, most of the other interventions were barely superior to placebo or were not superior at all. Placebo responses were often quite high and this complicates the assessment of active agents. While it complicates the design and interpretation of clinical trials, high response rates for active and sham interventions indicate that we can achieve symptom relief in many patients and thus give them some reassurance. If indeed most therapies are only marginally better than placebo, the differences in adverse effects should be weighed more strongly, a point that is especially important in view of the controversy surrounding metoclopramide. Mechanistic studies introduced the network of macrophages as another potentially important player in the development of gastroparesis. Results are too preliminary and are largely based on preclinical data but show up- and downregulation of cellular elements controlling gastric function. Thus, future developments may teach us how they interfere with some of these mechanisms in clinical settings, potentially making gastroparesis a reversible process.

Mo1530 - High Resolution Esophageal Manometry with a Solid Test Meal Improves Diagnostic Yield for Esophageal Dysmotility and Symptom Reproducibility: Validation Study in Asians

Mo1530 - High Resolution Esophageal Manometry with a Solid Test Meal Improves Diagnostic Yield for Esophageal Dysmotility and Symptom Reproducibility: Validation Study in Asians