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Efficacy and tolerability of various bowel preparations in diabetic patients: a randomized controlled trial.

ABSTRACT: Background and study aims ?Diabetes mellitus (DM) is an independent risk factor for poor bowel preparation prior to colonoscopy. Bisacodyl is a stimulant laxative that may mitigate colonic dysmotility associated with diabetes. We hypothesized that adding bisacodyl to split-dose bowel preparation (SDBP) would improve the quality of bowel preparation among patients with diabetes. Patients and methods ?Adult outpatients aged 18 to 80 years undergoing colonoscopy were recruited. One hundred and eighty-six patients with diabetes were randomly assigned to 1 of 3 treatment arms: 1) conventional 4?L of polyethylene glycol electrolyte lavage solution (PEG-ELS; conventional bowel preparation [CBP]); 2) split-dose of 4?L PEG-ELS (split-dose bowel preparation [SDBP]); or 3) split-dose of 4?L PEG-ELS preceded by 10?mg of oral bisacodyl 10 (SDBP-B). The primary outcome measure was bowel cleansing as indicated by Boston Bowel Preparation Scale (BBPS) score. Endoscopists were blinded to the preparation used. Secondary outcome measures were safety and patient tolerability. Results ?Of the 212 patients randomized, only 186 received assigned bowel preparation. There were no differences among the three study groups with regard to age, indication, duration of DM, insulin use, narcotic use, or presence of end-organ diabetic complications. There was a trend toward better bowel preparation quality among those receiving SDBP and SDBP-B compared to those receiving CBP, but the trend was not statistically significant ???6 BBPS; 67?% vs. 83?% vs. 75?%, P ?=?0.1). In terms of safety and tolerability, there were no differences among the three groups. Conclusion ?Adding bisacodyl to SDBP does not improve the quality of bowel preparation in patients with DM. Further efforts are needed to optimize colonoscopy bowel preparation in this population.

SUBMITTER: Madhoun MF

PROVIDER: S-EPMC6175603 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Efficacy and tolerability of various bowel preparations in diabetic patients: a randomized controlled trial.

Madhoun Mohammad F MF Chaudrey Khadija K KK Chisholm Sian S SS Ahmed Aftab A Frost Belinda B Tierney William M WM

Endoscopy international open 20181008 10

<b>Background and study aims</b> Diabetes mellitus (DM) is an independent risk factor for poor bowel preparation prior to colonoscopy. Bisacodyl is a stimulant laxative that may mitigate colonic dysmotility associated with diabetes. We hypothesized that adding bisacodyl to split-dose bowel preparation (SDBP) would improve the quality of bowel preparation among patients with diabetes. <b>Patients and methods</b> Adult outpatients aged 18 to 80 years undergoing colonoscopy were recruited. One hu ...[more]

PMID: 30302371

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Project description:IntroductionThere is limited data on the effects of low carbohydrate diets on renal outcomes particularly in patients with underlying diabetic kidney disease. Therefore, this study determined the safety and effects of very low carbohydrate (VLCBD) in addition to low protein diet (LPD) on renal outcomes, anthropometric, metabolic and inflammatory parameters in patients with T2DM and underlying mild to moderate kidney disease (DKD).Materials and methodsThis was an investigator-initiated, single-center, randomized, controlled, clinical trial in patients with T2DM and DKD, comparing 12-weeks of low carbohydrate diet (<20g daily intake) versus standard low protein (0.8g/kg/day) and low salt diet. Patients in the VLCBD group underwent 2-weekly monitoring including their 3-day food diaries. In addition, Dual-energy x-ray absorptiometry (DEXA) was performed to estimate body fat percentages.ResultsThe study population (n = 30) had a median age of 57 years old and a BMI of 30.68kg/m2. Both groups showed similar total calorie intake, i.e. 739.33 (IQR288.48) vs 789.92 (IQR522.4) kcal, by the end of the study. The VLCBD group showed significantly lower daily carbohydrate intake 27 (IQR25) g vs 89.33 (IQR77.4) g, p<0.001, significantly higher protein intake per day 44.08 (IQR21.98) g vs 29.63 (IQR16.35) g, p<0.05 and no difference in in daily fat intake. Both groups showed no worsening of serum creatinine at study end, with consistent declines in HbA1c (1.3(1.1) vs 0.7(1.25) %) and fasting blood glucose (1.5(3.37) vs 1.3(5.7) mmol/L). The VLCBD group showed significant reductions in total daily insulin dose (39(22) vs 0 IU, p<0.001), increased LDL-C and HDL-C, decline in IL-6 levels; with contrasting results in the control group. This was associated with significant weight reduction (-4.0(3.9) vs 0.2(4.2) kg, p = <0.001) and improvements in body fat percentages. WC was significantly reduced in the VLCBD group, even after adjustments to age, HbA1c, weight and creatinine changes. Both dietary interventions were well received with no reported adverse events.ConclusionThis study demonstrated that dietary intervention of very low carbohydrate diet in patients with underlying diabetic kidney disease was safe and associated with significant improvements in glycemic control, anthropometric measurements including weight, abdominal adiposity and IL-6. Renal outcomes remained unchanged. These findings would strengthen the importance of this dietary intervention as part of the management of patients with diabetic kidney disease.

Project description:Aims/hypothesis: Dietary restriction (DR) reduces adiposity and improves metabolism in patients with one or more symptoms of the metabolic syndrome. Nonetheless, it remains elusive whether the benefits of DR in humans are mediated by calorie or nutrient restriction. This study was conducted to identify whether isocaloric dietary protein restriction is sufficient to confer the beneficial effects of dietary restriction in patients with metabolic syndrome. Methods: We performed a prospective, randomized controlled dietary intervention under constant nutritional and medical supervision. A total of 21 individuals diagnosed with the metabolic syndrome was randomly assigned for caloric restriction (CR; n = 11, mean age 49 ± 8.5 years, female 63%; diet of 5,941 ± 686 KJ per day) or isocaloric dietary protein restriction (PR; n = 10, mean age 51.6 ± 8.9 years, female 50%; diet of 8,409 ± 2,360 KJ per day) and followed for 27 days. Results: Like CR, PR promoted weight loss (-6.6%, P= 0.0041) due to reduction in adiposity (-9.9%, P= 0.0007), associated with reductions in blood glucose (-52.7%, P= 0.0002), lipid levels (cholesterol, -35.4%, P= 0.0010; triglycerides, -39.5% P= 0.0022) and blood pressure (systolic, -37.7 P< 0.0001; diastolic, -73.2% P< 0.0001). PR resulted in enrichment of metabolic pathways related to the immune system such as B cell proliferation, lymphocyte proliferation and leukocyte proliferation in subcutaneous adipose tissue. Hence, a reduction in calorie intake or changes in the gut microbiome are not necessary to confer the metabolic benefits of DR. Instead, a reduction in protein intake with a mild increase in carbohydrate intake to maintain the isocaloric balance of the diet is sufficient to improve metabolic control. Conclusions/interpretation: Protein restriction is sufficient to confer almost the same clinical outcomes as calorie restriction without the need for a reduction in calorie intake. The isocaloric characteristic of the PR intervention makes this approach a more attractive and less drastic dietary strategy in clinical settings and has greater potential to be used as adjuvant therapy for people with the metabolic syndrome.

Project description:Patients with irritable bowel syndrome (IBS) are often placed on diets guided by food intolerance assays, although these have not been validated. We assessed the effects of individualised diets in patients with IBS guided by a leucocyte activation test.This is a parallel-group, double-blind, randomised controlled trial of 58 adults with IBS seen at an academic health centre in Northeast USA. Peripheral venous blood was analysed using a leucocyte activation test; individual foods were reported to produce positive or negative results. Participants were randomised to a 4-week diet with either individualised guidance to eliminate foods with positive assay results and allow foods with negative assay results (intervention), or with individualised guidance, matched in rigour and complexity, to eliminate foods with negative assay results and allow foods with positive assay results (comparison). The primary outcome was between-group differences in the IBS Global Improvement Scale (GIS). Secondary outcomes included reductions in IBS Symptom Severity Scale (SSS) scores and increases in IBS Adequate Relief (AR) and Quality of Life (QOL) scores. An aptamer-based proteomic analysis was conducted in strong responders.The intervention group had significantly greater increases in mean GIS score after 4 weeks (0.86 vs comparison; 95%?CI 0.05 to 1.67; p=0.04) and 8 weeks (1.22 vs comparison; 95%?CI 0.22 to 2.22; p=0.02). The intervention group also had significantly greater reductions in mean SSS score at 4 weeks (-61.78 vs comparison; 95%?CI -4.43 to -119.14; p=0.04) and 8 weeks (-66.42 vs comparison; 95%?CI -5.75 to -127.09; p=0.03). There were no significant differences between intervention and comparison groups in mean AR or QOL scores. A reduction in neutrophil elastase concentration was associated with reduced symptoms.Elimination diets guided by leucocyte activation tests reduced symptoms. These findings could lead to insights into the pathophysiology of IBS.NCT02186743.

Project description:The purpose of this study was to compare the efficacy and tolerability of combination therapy of ezetimibe and atorvastatin in patients with high LDL cholesterol that had not reached the lipid management target value with 10 mg atorvastatin monotherapy, against increasing the dose to 20 mg atorvastatin or switching to 2.5 mg rosuvastatin.This was an open-label, randomized, multicenter, 3-parallel-group comparison trial at 23 community hospitals and clinics in Japan (enrollment period March 2009 to May 2010) in 125 patients with high LDL cholesterol.A total of 125 Japanese patients with high LDL cholesterol level were randomized to 1 of the following 3 treatment groups: the ezetimibe (10 mg/d) and atorvastatin (10 mg/d) group, the atorvastatin (20 mg/d) group, or the rosuvastatin (2.5 mg/d) group for 12 weeks after treatment with 10 mg atorvastatin alone for 4 weeks.Percent change in LDL cholesterol level from baseline (4 weeks after treatment with 10 mg atorvastatin alone) until study completion.The percent change in LDL cholesterol level from baseline until study completion was statistically greater for the combination of 10 mg ezetimibe + 10 mg atorvastatin compared with increasing atorvastatin to 20 mg (-25.8% vs -15.1%; P < 0.0001). A similar result was observed for ezetimibe + atorvastatin compared with switching to 2.5 mgt rosuvastatin (-25.8% vs 0.8%; P < 0.0001). The proportion of patients who reached the target LDL cholesterol value with the combination of ezetimibe + atorvastatin was significantly higher than increasing atorvastatin and switching to rosuvastatin (78.7%, 41.3%, and 3.1%, respectively). Although 5 serious adverse experiences bearing no relation to the study medications were reported, there were no adverse reactions.The combination of 10 mg ezetimibe +10 mg atorvastatin was more effective than increasing atorvastatin to 20 mg or switching to 2.5 mg rosuvastatin in patients with hypercholesterolemia whose LDL cholesterol levels had not reached the recommended target value with 10 mg atorvastatin monotherapy for 4 weeks. Ezetimibe coadministration with atorvastatin was well tolerated. ClinicalTrials.gov identifier: NCT00871351.

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Efficacy and tolerability of various bowel preparations in diabetic patients: a randomized controlled trial.

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Efficacy and tolerability of various bowel preparations in diabetic patients: a randomized controlled trial.

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