Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial.

BACKGROUND: The Center for Disease Control and Prevention's National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve ≥ 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP's weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control. METHODS: We propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time. DISCUSSION: The NDPP is the dominant public health strategy for T2DM prevention. Changing the program's dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program's effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome. TRIAL REGISTRATION: NCT05235425. Registered February 11, 2022.

Mixed methods pilot study of a low-carbohydrate diabetes prevention programme among adults with pre-diabetes in the USA.

OBJECTIVES: (1) To estimate weight change from a low-carbohydrate diabetes prevention programme (LC-DPP) and (2) to evaluate the feasibility and acceptability of an LC-DPP. RESEARCH DESIGN: Single-arm, mixed methods (ie, integration of quantitative and qualitative data) pilot study. SETTING: Primary care clinic within a large academic medical centre in the USA. PARTICIPANTS: Adults with pre-diabetes and Body Mass Index of ≥25 kg/m2. INTERVENTION: We adapted the Centers for Disease Control and Prevention's National Diabetes Prevention Program (NDPP)-an evidence-based, low-fat dietary intervention-to teach participants to follow a very low-carbohydrate diet (VLCD). Participants attended 23 group-based classes over 1 year. OUTCOME MEASURES: Primary outcome measures were (1) weight change and (2) percentage of participants who achieved ≥5% wt loss. Secondary outcome measures included intervention feasibility and acceptability (eg, attendance and qualitative interview feedback). RESULTS: Our enrolment target was 22. One person dropped out before a baseline weight was obtained; data from 21 individuals were analysed. Mean weight loss in kilogram was 4.3 (SD 4.8) at 6 months and 4.9 (SD 5.8) at 12 months. Mean per cent body weight changes were 4.5 (SD 5.0) at 6 months and 5.2 (SD 6.0) at 12 months; 8/21 individuals (38%) achieved ≥5% wt loss at 12 months. Mean attendance was 10.3/16 weekly sessions and 3.4/7 biweekly or monthly sessions. Among interviewees (n=14), three factors facilitated VLCD adherence: (1) enjoyment of low-carbohydrate foods, (2) diminished hunger and cravings and (3) health benefits beyond weight loss. Three factors hindered VLCD adherence: (1) enjoyment of high-carbohydrate foods, (2) lack of social support and (3) difficulty preplanning meals. CONCLUSIONS: An LC-DPP is feasible, acceptable and may be an effective option to help individuals with pre-diabetes to lose weight. Data from this pilot will be used to plan a fully powered randomised controlled trial of weight loss among NDPP versus LC-DPP participants. TRIAL REGISTRATION NUMBER: NCT03258918.

Real-Time Characterization of Diminutive Colorectal Polyp Histology Using Narrow-Band Imaging: Implications for the Resect and Discard Strategy.

BACKGROUND & AIMS: Narrow-band imaging (NBI) allows real-time histologic classification of colorectal polyps. We investigated whether endoscopists without prior training in NBI can achieve the following thresholds recommended by the American Society for Gastrointestinal Endoscopy: for diminutive colorectal polyps characterized with high confidence, a ≥90% negative predictive value for adenomas in the rectosigmoid and a ≥90% agreement in surveillance intervals. METHODS: Twenty-six endoscopists from 2 tertiary care centers underwent standardized training in NBI interpretation. Endoscopists made real-time predictions of diminutive colorectal polyp histology and surveillance interval predictions based on NBI. Their performance was evaluated by comparing predicted with actual findings from histologic analysis. Multilevel logistic regression was used to assess predictors of performance. Cumulative summation analysis was used to characterize learning curves. RESULTS: The endoscopists performed 1451 colonoscopies and made 3012 diminutive polyp predictions (74.3% high confidence) using NBI. They made 898 immediate post-procedure surveillance interval predictions. An additional 505 surveillance intervals were determined with histology input. The overall negative predictive value for high-confidence characterizations in the rectosigmoid was 94.7% (95% confidence interval: 92.6%-96.8%) and the surveillance interval agreement was 91.2% (95% confidence interval: 89.7%-92.7%). Overall, 97.0% of surveillance interval predictions would have brought patients back on time or early. High-confidence characterization was the strongest predictor of accuracy (odds ratio = 3.42; 95% confidence interval: 2.72-4.29; P < .001). Performance improved over time, however, according to cumulative summation analysis, only 7 participants (26.9%) identified adenomas with sufficient sensitivity such that further auditing is not required. CONCLUSIONS: With standardized training, gastroenterologists without prior expertise in NBI were able to meet the negative predictive value and surveillance interval thresholds set forth by the American Society for Gastrointestinal Endoscopy. The majority of disagreement in surveillance interval brought patients back early. Performance improves with time, but most endoscopists will require ongoing auditing of performance. ClinicalTrials.gov ID NCT02441998.

Correlación entre síntomas gastrointestinales funcionales y la histopatología de la mucosa gástrica, incluyendo la infección por Helicobacter pylori, en Lima, Perú.

OBJECTIVE: This study aims to investigate the relationship between functional gastrointestinal disorders and histopathology characteristics, including H. pylori infection, of gastric mucosa, at Cayetano Heredia National Hospital, Lima-Peru, in 2013. MATERIALS AND METHODS: 112 patients were interviewed prospectively between June and July 2013 in the gastroenterology service. Dyspepsia, irritable bowel syndrome, and postprandial distress syndrome were characterized using the Rome III Survey. RESULTS: Pathology results were determined by gastric biopsies obtained by endoscopy. Of the patients interviewed, biopsy results were obtained for 101. 22.8% had atrophy, 24.8% had intestinal metaplasia, 57.4% presented with H pylori. CONCLUSIONS: Using chi-square analysis, no statistically significant relationship could be identified between clinical presentation and biopsy results.

Correlación entre síntomas gastrointestinales funcionales y la histopatología de la mucosa gástrica, incluyendo la infección por Helicobacter pylori, en Lima, Perú / Correlation between functional gastrointestinal disorders and gastric mucosa histopathology findings, including Helicobacter pylori infection, in Lima, Peru

This study aims to investigate the relationship between functional gastrointestinal disorders and histopathology characteristics, including H. pylori infection, of gastric mucosa, at Cayetano Heredia National Hospital, Lima-Peru, in 2013. Materials and methods: 112 patients were interviewed prospectively between June and July 2013 in the gastroenterology service. Dyspepsia, irritable bowel syndrome, and postprandial distress syndrome were characterized using the Rome III Survey. Results: Pathology results were determined by gastric biopsies obtained by endoscopy. Of the patients interviewed, biopsy results were obtained for 101. 22.8% had atrophy, 24.8% had intestinal metaplasia, 57.4% presented with H pylori. Conclusions: Using chisquare analysis, no statistically significant relationship could be identified between clinical presentation and biopsy results...

El objetivo de este estudio fue investigar la correlación que existe entre la presencia de síntomas gastrointestinales y los hallazgos histopatológicos de la biopsia gástrica incluyendo la presencia de la infección por Helicobacter pylori. Materiales y métodos: Este estudio prospectivo comprendió a 112 pacientes que se incluyeron entre junio y julio de 2013 en el Servicio de Gastroenterología del Hospital Nacional Cayetano Heredia, Lima-Perú a los que se les hizo endoscopía y biopsia gástrica. Los síntomas de dispepsia, síndrome de intestino irritable y síndrome de distrés post prandial fueron obtenidos usando las encuestas de Roma III. Resultados: De los pacientes a los que se les hizo la encuesta sólo en 101 se les evaluó la biopsia. 22,8% tuvo atrofia, 24,8% presentó metaplasia intestinal, y en 57,4% se reportó la infección por Helicobacter pylori. Conclusiones: Usando el análisis con chi-cuadrado no se pudo establecer ninguna correlación estadísticamente significativa entre la presentación clínica y los resultados de las biopsias...