scholarly journals Icodextrin reduces insulin resistance in non-diabetic patients undergoing automated peritoneal dialysis: results of a randomized controlled trial (STARCH)

2015 ◽  
Vol 30 (11) ◽  
pp. 1905-1911 ◽  
Author(s):  
Thyago Proença de Moraes ◽  
Maria Cláudia Cruz Andreoli ◽  
Maria Eugênia Canziani ◽  
Dirceu Reis da Silva ◽  
Jacqueline Costa Teixeira Caramori ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Diabetic Patients ◽  
Automated Peritoneal Dialysis ◽  
Randomized Controlled

scholarly journals Randomized, Controlled Trial of Glucose-Sparing Peritoneal Dialysis in Diabetic Patients

2013 ◽  
Vol 24 (11) ◽  
pp. 1889-1900 ◽  
Author(s):  
Philip K.T. Li ◽  
Bruce F. Culleton ◽  
Amaury Ariza ◽  
Jun-Young Do ◽  
David W. Johnson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Diabetic Patients ◽  
Randomized Controlled

scholarly journals Adequacy of automated peritoneal dialysis with and without manual daytime exchange: A randomized controlled trial

2006 ◽  
Vol 70 (9) ◽  
pp. 1649-1655 ◽  
Author(s):  
D. Demetriou ◽  
A. Habicht ◽  
M. Schillinger ◽  
W.H. Hörl ◽  
A. Vychytil
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Controlled Trial ◽  
Automated Peritoneal Dialysis ◽  
Randomized Controlled

Outcomes of Remote Patient Monitoring for Automated Peritoneal Dialysis: A Randomized Controlled Trial

Nephron ◽  
2021 ◽  
pp. 1-9
Author(s):  
Hee-Yeon Jung ◽  
Yena Jeon ◽  
Yon Su Kim ◽  
Dong Ki Kim ◽  
Jung Pyo Lee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Kidney Disease ◽  
Patient Monitoring ◽  
Controlled Trial ◽  
Staff Satisfaction ◽  
Remote Patient Monitoring ◽  
Automated Peritoneal Dialysis ◽  
Randomized Controlled ◽  
Remote Patient

<b><i>Introduction:</i></b> We hypothesize that remote patient monitoring (RPM) for automated peritoneal dialysis (APD) and feedback could enhance patient self-management and improve outcomes. The aim of this study was to evaluate the efficacy of RPM-APD compared to traditional APD (T-APD) without RPM. <b><i>Methods:</i></b> In this multicenter, randomized controlled trial, patients on APD were randomized to T-APD (<i>n</i> = 29) or RPM-APD (<i>n</i> = 28) at 12 weeks and followed until 25 weeks. Health-related quality of life (HRQOL), patient and medical staff satisfaction with RPM-APD, and dialysis-related outcomes were compared between the 2 groups. <b><i>Results:</i></b> We found no significant differences in HRQOL scores at the time of enrollment and randomization between RPM-APD and T-APD. At the end of the study, the RPM-APD group showed better HRQOL for the sleep domain (<i>p</i> = 0.049) than the T-APD group and the T-APD group showed better HRQOL for the sexual function domain (<i>p</i> = 0.030) than the RPM-APD group. However, we found no significant interactions between the time and groups in terms of HRQOL. Different HRQOL domains significantly improved over time in patients undergoing RPM-APD (effects of kidney disease, <i>p</i> = 0.025) and T-APD (burden of kidney disease, <i>p</i> = 0.029; physical component summary, <i>p</i> = 0.048). Though medical staff satisfaction with RPM-APD was neutral, most patients were quite satisfied with RPM-APD (median score 82; possible total score 105 on 21 5-item scales) and the rating scores were maintained during the study period. We found no significant differences in dialysis adherence, accuracy, adequacy, overhydration status, blood pressure, or the number of unplanned visits between the 2 groups. <b><i>Discussion/Conclusion:</i></b> Although HRQOL and dialysis-related outcomes were comparable between RPM-APD and T-APD, RPM-APD was positive in terms of patient satisfaction. Further long-term and large-scale studies will be required to determine the efficacy of RPM-APD. <b><i>Trial Registration:</i></b> CRIS identifier: KCT0003390, registered on December 14, 2018 – retrospectively registered, https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=12348.

scholarly journals Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edward C. Deehan ◽  
Eloisa Colin-Ramirez ◽  
Lucila Triador ◽  
Karen L. Madsen ◽  
Carla M. Prado ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Metabolic Effects ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

scholarly journals Effects of low glycemic index diet on insulin resistance among obese adolescent with non-alcoholic fatty liver disease: a randomized controlled trial

2019 ◽  
Vol 28 (2) ◽  
pp. 123-8 ◽  
Author(s):  
Agustini Utari ◽  
Muhammad Saifulhaq Maududi ◽  
Ninung Rose Diana Kusumawati ◽  
Maria Mexitalia
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Liver Disease ◽  
Nutrition Education ◽  
Fatty Liver Disease ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Low Glycemic Index

BACKGROUND Obesity is strongly correlated with insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Some studies suggest that dietary intake with low glycemic index (GI) may prevent IR and reduce the incidences of NAFLD. This study was aimed to determine the effects of low GI diet on IR among obese adolescents with NAFLD. METHODS This study was a randomized controlled trial conducted in two JuniorHigh Schools in Semarang, Indonesia. The subjects were 12–14 years obese students with NAFLD, which divided into intervention and control groups according to schools using block random allocation. The intervention group received nutrition education and lunch diet (low energy, low GI, and low fat); meanwhile, the control group only received nutrition education for 12 weeks. The biochemical evaluation included fasting blood glucose (FBG) and insulin levels. IR was assessed using homeostatic model assessment-insulin resistance (HOMA-IR). RESULTS Thirty-two subjects were enrolled in this study, 16 of which were assigned to the intervention group and the other to the control group. After 12 weeks, the energy and carbohydrate intake reduced in the intervention group (p < 0.05), FBG remained unchanged, and HOMA-IR increased (4.9 [3.7]–7.2 [3.5]) compared to the control group (6.4 [4.9]–5.5 [2.8]) (p < 0.05). Meanwhile, within the control group, there were no significant differences in the energy and carbohydrate intake as well as biochemical variables. CONCLUSIONS Low GI modification diet alone may not reduce IR in the obeseadolescents with NAFLD.

Randomized Controlled Trial Comparing Open versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The Capd I Trial

2017 ◽  
Vol 38 (2) ◽  
pp. 104-112 ◽  
Author(s):  
Jorinde H.H. van Laanen ◽  
Tom Cornelis ◽  
Barend M. Mees ◽  
Elisabeth J. Litjens ◽  
Magda M. van Loon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Open Surgery ◽  
Clinical Success ◽  
Controlled Trial ◽  
Laparoscopic Group ◽  
Randomized Controlled ◽  
Surgery Group ◽  
Fixation Techniques ◽  
Open Versus

Objective To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 – 4 weeks after insertion. Methods All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Results Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 – 4 weeks after insertion compared with 70% of patients in the laparoscopic group ( p = not significant [NS]). In the open surgery group there was 1 post- operative death (2%) compared with none in the laparoscopic group ( p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. Conclusion This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome.

Sign in / Sign up

Export Citation Format

Share Document