scholarly journals PREVENT: A Randomized, Placebo-Controlled Crossover Trial of Avexitide for Treatment of Post-Bariatric Hypoglycemia

2021 ◽  
Author(s):  
Colleen M Craig ◽  
Helen Margaret Lawler ◽  
Clare Jung Eun Lee ◽  
Marilyn Tan ◽  
Dawn Belt Davis ◽  
...  
Keyword(s):  
Crossover Trial ◽  
Random Order ◽  
Hyperinsulinemic Hypoglycemia ◽  
Electronic Diary ◽  
Mixed Meal ◽  
Continuous Glucose Monitor ◽  
Self Monitoring ◽  
Severe Event ◽  
Promising Treatment ◽  
Tolerance Testing

Abstract Context Post-bariatric hypoglycemia (PBH), characterized by enteroinsular axis overstimulation and hyperinsulinemic hypoglycemia, is a complication of bariatric surgery for which there is no approved therapy. Objective To evaluate efficacy and safety of avexitide [exendin(9-39)], a GLP-1 antagonist, for treatment of PBH. Design Phase II, randomized, placebo-controlled crossover study (PREVENT). Setting Multicenter. Participants Eighteen female patients with PBH. Intervention Placebo for 14 days followed by avexitide 30 mg BID and 60 mg QD, each for 14 days in random order. Main Outcome Measures Glucose nadir and insulin peak during mixed-meal tolerance testing (MMTT) and hypoglycemic events captured by self-monitoring of blood glucose (SMBG), electronic diary, and blinded continuous glucose monitor (CGM). Results Compared to placebo, avexitide 30 mg BID and 60 mg QD raised the glucose nadir by 21% (p=0.001) and 26% (p=0.0002) and lowered the insulin peak by 23% (p=0.029) and 21% (p=0.042), corresponding to 50% and 75% fewer participants requiring rescue during MMTT, respectively. Significant reductions in rates of Levels 1-3 hypoglycemia were observed, defined, respectively, as SMBG<70 mg/dL, SMBG<54 mg/dL, and a severe event characterized by altered mental and/or physical function requiring assistance. CGM demonstrated reductions in hypoglycemia without induction of clinically-relevant hyperglycemia. Avexitide was well-tolerated, with no increase in adverse events. Conclusions Avexitide administered for 28 days was well-tolerated and resulted in robust and consistent improvements across multiple clinical and metabolic parameters, reinforcing the targeted therapeutic approach and demonstrating durability of effect. Avexitide may represent a first promising treatment for patients with severe PBH.

Some pearl millet-based foods promote satiety or reduce glycaemic response in a crossover trial

2020 ◽  
pp. 1-31
Author(s):  
Anna M.R. Hayes ◽  
Fanny Gozzi ◽  
Aminata Diatta ◽  
Tom Gorissen ◽  
Clay Swackhamer ◽  
...  
Keyword(s):  
Gastric Emptying ◽  
Pearl Millet ◽  
Octanoic Acid ◽  
Crossover Trial ◽  
Normal Weight ◽  
Glycaemic Response ◽  
Continuous Glucose Monitor ◽  
Gastric Emptying Rate ◽  
White Rice ◽  
Traditionally Prepared

Abstract In a previous trial in Mali, we showed traditional pearl millet couscous and thick porridge delayed gastric emptying (~5 h half-emptying times) in a normal weight population compared to non-traditional carbohydrate-based foods (pasta, potatoes, white rice; ~3 h half-emptying times), and in a gastric simulator we showed millet couscous had slower digestion than wheat couscous. In light of these findings, we tested the hypothesis in a normal weight U.S. population (n=14) that millet foods would reduce glycaemic response (continuous glucose monitor), improve appetitive sensations (Visual Analog Scale ratings), as well as reduce gastric emptying rate (13C octanoic acid breath test). Five carbohydrate-based foods (millet couscous – commercial and self-made, millet thick porridge, wheat couscous, white rice) were fed in a crossover trial matched on available carbohydrate basis. Significantly lower overall glycaemic response was observed for all millet-based foods and wheat couscous compared to white rice (p≤0.05). Millet couscous (self-made) had significantly higher glycaemic response than millet couscous (commercial) and wheat couscous (p<0.0001), but as there were no differences in peak glucose values (p>0.05) an extended glycaemic response was indicated for self-made couscous. Millet couscous (self-made) had significantly lower hunger ratings (p<0.05) and higher fullness ratings (p<0.01) than white rice, millet thick porridge, and millet couscous (commercial). A normal gastric emptying rate (<3 h half-emptying times) was observed for all foods, with no significant differences among them (p>0.05). In conclusion, some traditionally prepared pearl millet foods show the potential to reduce glycaemic response and promote satiety.

scholarly journals Regulation of gastric and pancreatic lipase secretion by CCK and cholinergic mechanisms in humans

1997 ◽  
Vol 273 (2) ◽  
pp. G374-G380 ◽  
Author(s):  
J. Borovicka ◽  
W. Schwizer ◽  
C. Mettraux ◽  
C. Kreiss ◽  
B. Remy ◽  
...  
Keyword(s):  
Gastric Emptying ◽  
Pancreatic Lipase ◽  
Random Order ◽  
Dietary Lipids ◽  
Cholinergic Mechanisms ◽  
Mixed Meal ◽  
Fat Digestion ◽  
Gastric Lipase ◽  
Cck Release

Gastric lipase (HGL) contributes significantly to fat digestion. However, little is known about its neurohormonal regulation in humans. We studied the role of CCK and cholinergic mechanisms in the postprandial regulation of HGL and pancreatic lipase (HPL) secretion in six healthy subjects. Gastric emptying of a mixed meal and outputs of HGL, pepsin, acid, and HPL were determined with a double-indicator technique. Three experiments were performed in random order: intravenous infusion of 1) placebo, 2) low-dose atropine (5 micrograms.kg-.h-1), and 3) the CCK-A receptor antagonist loxiglumide (22 mumol.kg-.h-1). Atropine decreased postprandial outputs of HGL, pepsin, gastric acid, and HPL (P < 0.03) while slowing gastric emptying (P < 0.05). Loxiglumide markedly increased the secretion of HGL, pepsin, and acid while distinctly reducing HPL outputs and accelerating gastric emptying (P < 0.03). Plasma CCK and gastrin levels increased during loxiglumide infusion (P < 0.03). Atropine enhanced gastrin but not CCK release. Postprandial HGL, pepsin, and acid secretion are under positive cholinergic but negative CCK control, whereas HPL is stimulated by cholinergic and CCK mechanisms. We conclude that CCK and cholinergic mechanisms have an important role in the coordination of HGL and HPL secretion to optimize digestion of dietary lipids in humans.

Inhibition of gastric emptying by acarbose is correlated with GLP-1 response and accompanied by CCK release

2001 ◽  
Vol 281 (3) ◽  
pp. G752-G763 ◽  
Author(s):  
Feruze Y. Enç ◽  
Neşe I˙meryüz ◽  
Levent Akin ◽  
Turgut Turoğlu ◽  
Fuat Dede ◽  
...  
Keyword(s):  
Gastric Emptying ◽  
Peptide Yy ◽  
Area Under The Curve ◽  
Gut Hormones ◽  
Random Order ◽  
Mixed Meal ◽  
Carbohydrate Absorption ◽  
Plasma Response ◽  
Glucagon Like Peptide ◽  
Glucagon Like Peptide 1

We investigated the effect of acarbose, an α-glucosidase and pancreatic α-amylase inhibitor, on gastric emptying of solid meals of varying nutrient composition and plasma responses of gut hormones. Gastric emptying was determined with scintigraphy in healthy subjects, and all studies were performed with and without 100 mg of acarbose, in random order, at least 1 wk apart. Acarbose did not alter the emptying of a carbohydrate-free meal, but it delayed emptying of a mixed meal and a carbohydrate-free meal given 2 h after sucrose ingestion. In meal groups with carbohydrates, acarbose attenuated responses of plasma insulin and glucose-dependent insulinotropic polypeptide (GIP) while augmenting responses of CCK, glucagon-like peptide-1 (GLP-1), and peptide YY (PYY). With mixed meal + acarbose, area under the curve (AUC) of gastric emptying was positively correlated with integrated plasma response of GLP-1 ( r = 0.68 , P < 0.02). With the carbohydrate-free meal after sucrose and acarbose ingestion, AUC of gastric emptying was negatively correlated with integrated plasma response of GIP, implying that prior alteration of carbohydrate absorption modifies gastric emptying of a meal. The results demonstrate that acarbose delays gastric emptying of solid meals and augments release of CCK, GLP-1, and PYY mainly by retarding/inhibiting carbohydrate absorption. Augmented GLP-1 release by acarbose appears to play a major role in the inhibition of gastric emptying of a mixed meal, whereas CCK and PYY may have contributory roles.

scholarly journals Continuous Glucose Monitoring for Evaluation of Glycemic Excursions after Gastric Bypass

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Florencia Halperin ◽  
Mary Elizabeth Patti ◽  
Megan Skow ◽  
Muhammad Bajwa ◽  
Allison B. Goldfine
Keyword(s):  
Gastric Bypass ◽  
Continuous Glucose Monitoring ◽  
Rare Complication ◽  
Glucose Monitoring ◽  
Glycemic Variability ◽  
Hyperinsulinemic Hypoglycemia ◽  
History Of ◽  
Clinically Significant ◽  
Asymptomatic Subjects ◽  
Tolerance Testing

Background. Hyperinsulinemic hypoglycemia with neuroglycopenia is a rare complication of Roux-en-Y gastric bypass (RYGB). We hypothesized that continuous glucose monitoring (CGM) would be useful to characterize glycemic variability after RYGB.Methods. CGM and mixed meal tolerance testing (MMTT) were performed on sixteen post-RYGB subjects, ten with a history of neuroglycopenia on medical treatment and six asymptomatic controls.Results. 9 of 10 subjects with neuroglycopenia developed hypoglycemia defined by glucose <70 mg/dL on CGM, and 3 of 9 on MMTT. In asymptomatic subjects, 3 of 6 had asymptomatic hypoglycemia during CGM, and 3 of 5 on MMTT. Therefore, the sensitivity and specificity to detect clinically significant hypoglycemia was 90% and 50% for CGM and 33% and 40% for MMTT.Conclusions. Asymptomatic hypoglycemia after RYGB is more frequent than commonly recognized. For clinicians evaluating patients for postbypass neuroglycopenia, CGM may be a valuable diagnostic tool.

scholarly journals Effect of meal composition and alcohol consumption on postprandial glucose concentration in subjects with type 1 diabetes: a randomized crossover trial

2021 ◽  
Vol 9 (1) ◽  
pp. e002399
Author(s):  
Alia García ◽  
Vanessa Moscardó ◽  
Agustín Ramos-Prol ◽  
Julián Díaz ◽  
Miguel Boronat ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Type 1 Diabetes ◽  
Crossover Trial ◽  
Postprandial Glucose ◽  
High Fat ◽  
Mixed Meal ◽  
Low Protein ◽  
Randomized Crossover Trial ◽  
Meal Composition

IntroductionMeal composition is known to affect glycemic variability and glucose control in type 1 diabetes. The objective of this work was to evaluate the effect of high carbohydrate meals of different nutritional composition and alcohol on the postprandial glucose response in patients with type 1 diabetes.Research design and methodsTwelve participants were recruited to this randomized crossover trial. Following a 4-week run-in period, participants received a mixed meal on three occasions with the same carbohydrate content but different macronutrient composition: high protein-high fat with alcohol (0.7g/kg body weight, beer), high protein-high fat without alcohol, and low protein-low fat without alcohol at 2-week intervals. Plasma and interstitial glucose, insulin, glucagon, growth hormone, cortisol, alcohol, free fatty acids, lactate, and pH concentrations were measured during 6 hours. A statistical analysis was then carried out to determine significant differences between studies.ResultsSignificantly higher late postprandial glucose was observed in studies with higher content of fats and proteins (p=0.0088). This was associated with lower time in hypoglycemia as compared with the low protein and fat study (p=0.0179), at least partially due to greater glucagon concentration in the same period (p=0.04). Alcohol significantly increased lactate, decreased pH and growth hormone, and maintained free fatty acids suppressed during the late postprandial phase (p<0.001), without significant changes in plasma glucose.ConclusionsOur data suggest that the addition of proteins and fats to carbohydrates increases late postprandial blood glucose. Moreover, alcohol consumption together with a mixed meal has relevant metabolic effects without any increase in the risk of hypoglycemia, at least 6 hours postprandially.Trial registration numberNCT03320993.

scholarly journals Fasting Glucose Response to Evening Snacks That Differ by Carbohydrate and Fat Composition: A 6-Week, Randomized, Crossover Trial in Subjects with Impaired Fasting Glucose

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1143-1143
Author(s):  
Philip Sapp ◽  
Kristina Petersen ◽  
Penny Kris-Etherton
Keyword(s):  
G Protein ◽  
Plasma Glucose ◽  
Crossover Trial ◽  
Fasting Glucose ◽  
Disease Risk ◽  
Cardiovascular Disease Risk ◽  
Saturated Fat ◽  
Random Order ◽  
Glucose Response ◽  
Randomized Crossover Trial

Abstract Objectives To examine the effect of consuming one ounce of peanuts (PNUT) as an evening snack on fasting plasma glucose and other cardiovascular disease risk factors, compared to an isocaloric lower fat higher carbohydrate snack (LFHC), in individuals with IFG. Methods Fifty-one individuals with IFG (52% male; 42 ± 15 y; BMI 28 ± 5.6 kg/m2; glucose 105 ± 4.9 mg/dL) were enrolled in this two-period, randomized, crossover trial. In random order, subjects consumed each snack in the evening (after dinner and before bedtime) for 6 weeks (PNUT: 164 kcal, 14 g fat, 2.2 g saturated fat, 6 g carbohydrate, 7 g protein, 2.4 g fiber; LFHC: 165 kcal, 6 g fat, 2 g saturated fat, 22 g carbohydrate, 7 g protein, 3.0 g fiber). Subjects were told not to consume other caloric foods/beverages after dinner. On two consecutive days at the beginning and end of each diet period a fasting blood sample was assessed for plasma glucose, serum lipids/lipoproteins, and insulin. Blood pressure (BP) and pulse wave velocity (PWV) were measured at each time point. Results Compared with baseline (100 mg/dL, 95% CI 99, 102), glucose was unchanged following both conditions (PNUT: −0.9 mg/dL 95% CI −2.1, 1.3; LFHC: −0.4 mg/dL 95% CI −2.6, 0.8) with no between-condition difference (P &gt; 0.05). Changes for LDL-C from baseline differed between conditions (−4.8 mg/dL; 95% CI −9.2, −0.4); there were no within-condition changes from baseline (LFHC −2.3 mg/dL, 95% CI −5.7, 1.0; PNUT 2.5 mg/dL, 95% CI −0.9, 5.8). Greater triglyceride lowering was observed with PNUT (−17 mg/dL, 95% CI −28, −6.2) vs. LFHC (−5.7 mg/dL, 95% CI −17, 5.1). There were no condition effects for weight, HDL-C, insulin, BP or PWV. In a post hoc analysis of subjects who had IFG (&gt;99 mg/dL) at baseline (107 mg/dL, 95% CI 106, 108), glucose was lowered compared to baseline for both conditions (PNUT: −2.6 mg/dL, 95% CI −4.6, −0.6; LFHC: −3.1 mg/dL, 95% CI −5.1, −1.0). Conclusions In individuals with IFG, consuming a relatively low-calorie, mixed macronutrient, nighttime snack improves fasting glucose levels. Greater reductions in triglycerides were observed with evening peanut consumption, which may be explained by the lower carbohydrate and higher fat content. Funding Sources The Peanut Institute Supported by the National Center for Advancing Translational Sciences, National Institutes of Health.

scholarly journals Micronutrient supplementation of lactating Guatemalan women acutely increases infants’ intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial

2020 ◽  
Vol 112 (3) ◽  
pp. 669-682
Author(s):  
Juliana A Donohue ◽  
Noel W Solomons ◽  
Daniela Hampel ◽  
Setareh Shahab-Ferdows ◽  
Mónica N Orozco ◽  
...  
Keyword(s):  
Divided Dose ◽  
Bolus Dose ◽  
Crossover Trial ◽  
Random Order ◽  
Acute Effects ◽  
Randomized Crossover Trial ◽  
Maternal Supplementation ◽  
B Vitamin ◽  
To Receive ◽  
Kinetics Of

ABSTRACT Background Maternal supplementation during lactation could increase milk B-vitamin concentrations, but little is known about the kinetics of milk vitamin responses. Objectives We compared acute effects of maternal lipid-based nutrient supplement (LNS) consumption (n = 22 nutrients, 175%–212% of the RDA intake for the nutrients examined), as a single dose or at spaced intervals during 8 h, on milk concentrations and infant intake from milk of B-vitamins. Methods This randomized crossover trial in Quetzaltenango, Guatemala included 26 mother–infant dyads 4–6 mo postpartum who were randomly assigned to receive 3 treatments in a random order: bolus 30-g dose of LNS (Bolus); 3 × 10-g doses of LNS (Divided); and no LNS (Control), with control meals. Mothers attended three 8-h visits during which infant milk consumption was measured and milk samples were collected at every feed. Infant intake was assessed as $\mathop \sum \nolimits_{i\ = \ 1}^n ( {{\rm{milk\ volum}}{{\rm{e}}_{{\rm{feed\ }}n}} \times \ {\rm{nutrient\ concentratio}}{{\rm{n}}_{{\rm{feed}}\ n}}} )$ over 8 h. Results Maternal supplementation with the Bolus or Divided dose increased least-squares mean (95% CI) milk and infant intakes of riboflavin [milk: Bolus: 154.4 (138.2, 172.5) μg · min−1 · mL−1; Control: 84.5 (75.8, 94.3) μg · min−1 · mL−1; infant: Bolus: 64.5 (56.1, 74.3) μg; Control: 34.5 (30.0, 39.6) μg], thiamin [milk: Bolus: 10.9 (10.1, 11.7) μg · min−1 · mL−1; Control: 7.7 (7.2, 8.3) μg · min−1 · mL−1; infant: Bolus: 5.1 (4.4, 6.0) μg; Control: 3.4 (2.9, 4.0) μg], and pyridoxal [milk: Bolus: 90.5 (82.8, 98.9) μg · min−1 · mL−1; Control: 60.8 (55.8, 66.3) μg · min−1 · mL−1; infant: Bolus: 39.4 (33.5, 46.4) μg; Control: 25.0 (21.4, 29.2) μg] (all P &lt; 0.001). Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min−1 · mL−1; Control: 0.041 (0.035, 0.048) μg · min−1 · mL−1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018) μg, P = 0.001] compared with Control. Niacin was unaffected. Conclusions Maternal supplementation with LNS as a Bolus or Divided dose was similarly effective at increasing milk riboflavin, thiamin, and pyridoxal and infant intakes, whereas only the Bolus dose increased cobalamin. Niacin was unaffected in 8 h. This trial was registered at clinicaltrials.gov as NCT02464111.

Prebiotic effect of two grams of lactulose in healthy Japanese women: a randomised, double-blind, placebo-controlled crossover trial

2019 ◽  
Vol 10 (6) ◽  
pp. 629-639 ◽  
Author(s):  
Y. Sakai ◽  
N. Seki ◽  
K. Hamano ◽  
H. Ochi ◽  
F. Abe ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Crossover Trial ◽  
Random Order ◽  
Japanese Women ◽  
Double Blind ◽  
Colony Forming Units ◽  
Significant Difference ◽  
Faecal Consistency ◽  
Bristol Stool Scale ◽  
Trial Participants

Sixty healthy Japanese women with a defaecation frequency of 2-4 times/week participated in this randomised, double-blind crossover trial. Participants received 2 g/day lactulose for 2 weeks and placebo in a random order, separated by a washout period of 3 weeks. Eight participants were excluded who did not satisfy the conditions, and therefore data from 52 were analysed. The primary outcome was defaecation frequency and the secondary outcomes were the number of defaecation days, faecal consistency, faecal volume, and the number and percentage of Bifidobacterium in faeces. The defaecation frequency (times/week) was significantly higher during lactulose (4.28±0.23) than placebo (3.83±0.23) treatment (delta (Δ) 0.45 [95% confidence interval (CI) 0.10-0.80], P=0.013). The defaecation days (days/week) was significantly higher during lactulose (3.77±0.17) than placebo (3.47±0.17) treatment (Δ0.30 [95% CI 0.04-0.56], P=0.024). Faecal consistency using the Bristol Stool Scale (/defaecation) was significantly higher during lactulose (3.84±0.10) than placebo (3.68±0.10) treatment (Δ0.16 [95% CI 0.00-0.31], P=0.044). Faecal volume (/week) was significantly higher during lactulose (21.73±3.07) than placebo (17.65±3.07) treatment (Δ4.08 [95% CI 0.57-7.60], P=0.024). The number of Bifidobacterium in faeces (log colony forming units/g faeces) was significantly higher during lactulose (9.53±0.06) than placebo (9.16±0.06) treatment (Δ0.37 [95% CI 0.23-0.49], P<0.0001). The percentage of Bifidobacterium in faeces was also significantly higher during lactulose (25.3±1.4) than placebo (18.2±1.4) treatment (Δ7.1 [95% CI 2.9-11.4], P=0.0014). Finally, straining at defaecation (/defaecation) during lactulose (3.62±0.24) treatment was significantly lower than during placebo (3.97±0.24) treatment (Δ0.35 [95% CI -0.69 – -0.02], P=0.037). No significant difference was observed between lactulose and placebo with regard to flatulence. Severe adverse effects did not occur. Thus, oral ingestion of 2 g/day lactulose had a prebiotic effect, increasing the number and percentage of bifidobacteria in faeces, softening the faeces, and increasing defaecation frequency, but without increasing flatulence.

scholarly journals Importance of Multiple Reinforcing Comments and Areas for Change in Optimizing Dietary and Exercise Self-Monitoring Feedback in Behavioral Weight Loss Programs: Factorial Design (Preprint)

2020 ◽  
Author(s):  
Rebecca Krukowski ◽  
Hyeonju Kim ◽  
Melissa Stansbury ◽  
Qian Li ◽  
Saunak Sen ◽  
...  
Keyword(s):  
Weight Loss ◽  
Factorial Design ◽  
Random Order ◽  
Behavioral Changes ◽  
Behavioral Weight Loss ◽  
Response Scale ◽  
Core Element ◽  
Self Monitoring ◽  
The Future ◽  
The Individual

BACKGROUND Individualized dietary and physical activity self-monitoring feedback is a core element of behavioral weight loss interventions and is associated with clinically significant weight loss. To our knowledge, no studies have evaluated individuals’ perspectives on the composition of feedback messages or the effect of feedback composition on the motivation to self-monitor. OBJECTIVE This study aims to assess the perceptions of feedback emails as a function of the number of comments that reinforce healthy behavior and the number of areas for change (ie, behavioral changes that the individual might make to have an impact on weight) identified. METHODS Emailed feedback followed a factorial design with 2 factors (ie, reinforcing comments and areas for change), each with 3 levels (ie, 1, 4, or 8 comments). A total of 250 adults with overweight or obesity who were interested in weight loss were recruited from the Qualtrics research panel. Participants read 9 emails presented in a random order. For each email, respondents answered 8 questions about the likelihood to self-monitor in the future, motivation for behavioral change, and perceptions of the counselor and the email. A mixed effects ordinal logistic model was used to compute conditional odds ratios and predictive margins (ie, average predicted probability) on a 5-point Likert response scale to investigate the optimal combination level of the 2 factors. RESULTS Emails with more reinforcing comments or areas for change were better received, with small incremental benefits for 8 reinforcing comments or areas for change versus 4 reinforcing comments or areas for change. Interactions indicated that the best combination for 3 of 8 outcomes assessed (ie, motivation to make behavioral changes, counselor’s concern for their welfare, and the perception that the counselor likes them) was the email with 8 reinforcing comments and 4 areas for change. Emails with 4 reinforcing comments and 4 areas for change resulted in the highest average probability of individuals who reported being very likely to self-monitor in the future. CONCLUSIONS The study findings suggest how feedback might be optimized for efficacy. Future studies should explore whether the composition of feedback email affects actual self-monitoring performance.

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