POS-679 Safety and efficacy of using cereal food (Frugra®) to improve blood pressure and bowel health in patients undergoing chronic hemodialysis: A pilot study

Introduction: The Dietary Approaches to Stop Hypertension (DASH) eating pattern is widely used for lowering blood pressure in the United States. Food preference and intake volume are quite different among American and Japanese diet; therefore, it is necessary to develop a modified version of DASH dietary pattern for Japanese people (JDASH). Hypothesis: The JDASH is feasible, safe and effective among Japanese people. Methods: This crossover pilot study recruited Japanese men and women aged 30 years and over. Participants were randomized to a three week JDASH diet followed by a three week control diet, or the reverse sequence. Intervention periods were separated by two weeks’ washout in which participants returned to their usual diet. The JDASH dietary pattern consisted of higher potassium, magnesium, calcium, dietary fiber, and n-3 fatty acid and lower sodium than Japanese typical diet. The nutrient balance of the control diet was average Japanese diet based on the National Health and Nutrition Survey in Japan. Primary outcome of this trial was a change in 24 hour urine sodium-to-potassium (Na/K) ratios and secondary outcomes were changes in home and office blood pressure values, lipoprotein profiles and body mass index. These outcomes were from 24 hour urine and blood specimens taken measured before and on the last day of each experimental period. The impact on these measurements was calculated with generalized estimating equation model in consideration of the sequences of intervention. Results: The JDASH diet was well tolerated and with no dropouts. No participant reported any adverse effect regarding this intervention diet and no adverse effects were also observed in biological measures. There were no differences in biological measurements between two diets before intervention. A significant difference in 24 hour urine Na/K ratio was observed (-4.33 mol/mol, p<0.001) between the JDASH diet and the control diet. The differences of systolic blood pressure were - 2.1 mmHg (p=0.396) at the office and -0.1 mmHg (p=0.956) at home, respectively. Significant differences in body mass index and low density lipoprotein were -0.4 kg/m 2 (p=0.002) and -11.0 mg/dl (p=0.038), respectively. Conclusion: Developed modified DASH dietary pattern for Japanese were significantly decrease 24 hour urine Na/K ratio. In conclusion, the results of this pilot study showed the feasibility, safety and efficacy.

Download Full-text

Phase 2a Pilot Study to Explore Safety and Efficacy of NBMI Treatment in Patients With Beta Thalassemia Major, Requiring Iron Chelation

Case Medical Research ◽

10.31525/ct1-nct04092205 ◽

2019 ◽

Author(s):

Keyword(s):

Pilot Study ◽

Iron Chelation ◽

Thalassemia Major ◽

Beta Thalassemia ◽

Safety And Efficacy ◽

Beta Thalassemia Major

Download Full-text

Cardiovascular safety and efficacy of metformin-SGLT2i versus metformin-sulfonylureas in type 2 diabetes: systematic review and meta-analysis of randomized controlled trials

Scientific Reports ◽

10.1038/s41598-020-80603-8 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Desye Gebrie ◽

Desalegn Getnet ◽

Tsegahun Manyazewal

Keyword(s):

Blood Pressure ◽

Type 2 Diabetes ◽

Combination Therapy ◽

Adverse Events ◽

Meta Analysis ◽

Controlled Trials ◽

Safety And Efficacy ◽

Randomized Controlled ◽

Sodium Glucose Cotransporter

AbstractDiabetes is a serious threat to global health and among the top 10 causes of death, with nearly half a billion people living with it worldwide. Treating patients with diabetes tend to become more challenging due to the progressive nature of the disease. The role and benefits of combination therapies for the management of type 2 diabetes are well-documented, while the comparative safety and efficacy among the different combination options have not been elucidated. We aimed to systematically synthesize the evidence on the comparative cardiovascular safety and efficacy of combination therapy with metformin-sodium-glucose cotransporter-2 inhibitors versus metformin-sulfonylureas in patients with type 2 diabetes. We searched MEDLINE-PubMed, Embase, Cochrane Library, and ClinicalTrials.gov up to 15 August 2019 without restriction in the year of publication. We included randomized controlled trials of patients with type 2 diabetes who were on metformin-sodium-glucose cotransporter-2 inhibitors or metformin-sulphonylureas combination therapy at least for a year. The primary endpoints were all-cause mortality and serious adverse events, and the secondary endpoints were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and changes in glycated hemoglobin A1c (HbA1c), body weight, fasting plasma glucose, blood pressure, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. We used a random-effects meta-analysis model to estimate mean differences for continuous outcomes and risk ratio for dichotomous outcomes. We followed PICOS description model for defining eligibility and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for reporting results. Of 3,190 citations, we included nine trials involving 10,974 participants. The pooled analysis showed no significant difference in all-cause mortality (risk ration [RR] = 0.93, 95% CI [0.52, 1.67]), serious adverse events (RR = 0.96, 95% CI [0.79, 1.17]) and adverse events (RR = 1.00, 95% CI [0.99, 1.02]) between the two, but in hypoglycemia (RR = 0.13, 95% CI [0.10, 0.17], P < 0.001). Participants taking metformin-sodium glucose cotransporter-2 inhibitors showed a significantly greater reduction in HbA1c (mean difference [MD] = − 0.10%, 95% CI [− 0.17, − 0.03], body weight (MD = − 4.57 kg, 95% CI [− 4.74, − 4.39], systolic blood pressure (MD = − 4.77 mmHg, 95% CI [− 5.39, − 4.16]), diastolic blood pressure (MD = − 2.07 mmHg, 95% CI [− 2.74, − 1.40], and fasting plasma glucose (MD = − 0.55 mmol/L, 95% CI [− 0.69, − 0.41]), p < 0.001. Combination therapy of metformin and sodium-glucose cotransporter-2 inhibitors is a safe and efficacious alternative to combination therapy of metformin and sulphonylureas for patients with type 2 diabetes who are at risk of cardiovascular comorbidity. However, there remains a need for additional long-term randomized controlled trials as available studies are very limited and heterogeneous.

Download Full-text

Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽

10.1136/bmjopen-2020-048541 ◽

2021 ◽

Vol 11 (6) ◽

pp. e048541

Author(s):

Anna-Maria Hoffmann-Vold ◽

Håvard H Fretheim ◽

Vikas K Sarna ◽

Imon Barua ◽

Maylen N Carstens ◽

...

Keyword(s):

Systemic Sclerosis ◽

Pilot Study ◽

Phase Ii ◽

Intestinal Microbiome ◽

Induction Phase ◽

Inflammatory Disorder ◽

Faecal Microbiota ◽

Safety And Efficacy ◽

Faecal Microbiota Transplantation ◽

Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

Download Full-text