Dataset Information

Double-blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study.

ABSTRACT: Setting:Bariatric surgery is indicated for patients diagnosed with obesity and type 2 diabetes. Many patients achieve type 2 diabetes remission soon after bariatric surgery. Even though most maintain good glycemic control, remission is not maintained in all patients, and as a result, some patients may relapse. Type 2 diabetes relapse is common in patients who regain weight; weight regain is prevalent 1 to 2 years after surgery. Additional pharmacotherapy may be required to aid bariatric surgery in fostering weight loss and reducing blood glucose levels. Objectives:The purpose of this clinical trial was to determine the effects of canagliflozin in participants who initially achieved type 2 diabetes remission but subsequently relapsed. Methods:The double-blinded, randomized, and prospective study recruited participants (n = 16) roughly 3 years after bariatric surgery. The participants were followed for 6 months. Results:Body mass index (-1.24 kg/m2) and body weight (-3.7 kg) were significantly reduced with canagliflozin therapy versus placebo. There were improvements in body fat composition as denoted by reductions in android (-3.00%) and truncal (-2.67%) fat. Also, there were differences in blood glucose and hemoglobin A1C at 6 months. Conclusion:After bariatric surgery, canagliflozin improved weight loss and glycemic outcomes in participants with type 2 diabetes. Canagliflozin also facilitated improvements in body fat composition.

SUBMITTER: Kashyap SR

PROVIDER: S-EPMC7278903 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Double-blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study.

Kashyap Sangeeta R SR Kheniser Karim K Aminian Ali A Schauer Philip P Le Roux Carel C Burguera Bartolome B

Obesity science & practice 20200317 3

<h4>Setting</h4>Bariatric surgery is indicated for patients diagnosed with obesity and type 2 diabetes. Many patients achieve type 2 diabetes remission soon after bariatric surgery. Even though most maintain good glycemic control, remission is not maintained in all patients, and as a result, some patients may relapse. Type 2 diabetes relapse is common in patients who regain weight; weight regain is prevalent 1 to 2 years after surgery. Additional pharmacotherapy may be required to aid bariatric ...[more]

PMID: 32523714

Similar Datasets

Project description:Background:Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a "real-world" trial in cardiac surgery. Objective:We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design:A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting:A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants:Patients undergoing planned, isolated coronary revascularization. Measurements:Serum creatinine and patient weight were measured daily postoperatively. Methods:Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results:The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, "risk" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas "injury" occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations:The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions:This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

Project description:Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response, which is associated with postoperative morbidity and mortality. Hemoadsorption (HA) of cytokines may suppress inflammatory responses and improve outcomes. We tested a new sorbent used for HA (CytoSorb™; CytoSorbents Europe GmbH, Berlin, Germany) installed in the CPB circuit on changes of pro- and anti-inflammatory cytokines levels, inflammation markers, and differences in patients' perioperative course.In this first pilot trial, 37 blinded patients were undergoing elective CPB surgery at the Medical University of Vienna and were randomly assigned to HA (n = 19) or control group (n = 18). The primary outcome was differences of cytokine levels (IL-1?, IL-6, IL-18, TNF-?, and IL-10) within the first five postoperative days. We also analyzed whether we can observe any differences in ex vivo lipopolysaccharide (LPS)-induced TNF-? production, a reduction of high-mobility box group 1 (HMGB1), or other inflammatory markers. Additionally, measurements for fluid components, blood products, catecholamine treatment, bioelectrical impedance analysis (BIA), and 30-day mortality were analyzed.We did not find differences in our primary outcome immediately following the HA treatment, although we observed differences for IL-10 24 hours after CPB (HA: median 0.3, interquartile range (IQR) 0-4.5; control: not traceable, P = 0.0347) and 48 hours after CPB (median 0, IQR 0-1.2 versus not traceable, P = 0.0185). We did not find any differences for IL-6 between both groups, and other cytokines were rarely expressed. We found differences in pretreatment levels of HMGB1 (HA: median 0, IQR 0-28.1; control: median 48.6, IQR 12.7-597.3, P = 0.02083) but no significant changes to post-treatment levels. No differences in inflammatory markers, fluid administration, blood substitution, catecholamines, BIA, or 30-day mortality were found.We did not find any reduction of the pro-inflammatory response in our patients and therefore no changes in their perioperative course. However, IL-10 showed a longer-lasting anti-inflammatory effect. The clinical impact of prolonged IL-10 needs further evaluation. We also observed strong inter-individual differences in cytokine levels; therefore, patients with an exaggerated inflammatory response to CPB need to be identified. The implementation of HA during CPB was feasible.ClinicalTrials.gov: NCT01879176, registration date: June 7, 2013.

Project description:ObjectiveTo perform a pilot study to assess the efficacy of intraneural facilitation, a novel manual technique, in the treatment of carpal tunnel syndrome (CTS).DesignPatients with clinical and electrodiagnostic evidence of CTS were randomized into intraneural facilitation or sham groups.SettingElectrodiagnostic laboratory in a university medical center.ParticipantsPatients referred to our electrodiagnostic laboratory were screened based on nerve conduction studies that were diagnostic for distal median neuropathy at the wrist or CTS. A total of 14 participants were enrolled; 4 participants withdrew prior to randomization, with the remaining 10 participants (N=10) divided equally between treatment and control groups. There was a 9:1 female-to-male sex ratio and average duration of symptoms was 28.5 months.InterventionsTreatment was performed twice weekly for 3 weeks.Main outcome measuresPrimary outcomes were the Boston Carpel Tunnel Questionnaire (BCTQ) and Boston Functional Status Scale at enrollment and at 1 week and 3 months after completion of intervention. A secondary outcome was ultrasonography (US) of the median nerve performed at baseline and 1 week after intervention.ResultsTen participants completed the trial, 5 each in the treatment and 5 each in the sham groups. The total percentage change in BCTQ and Boston Functional Status Scale scores decreased at baseline, 1 week, and 3 months after intervention. However, there was no difference between control and intraneural facilitation group. Within-group differences showed nonstatistically significant differences for all the groups except for the BCTQ questionnaires after 3 months of intraneural facilitation therapy was completed (P=.043) compared with baseline. Between-group differences showed large effects for the BCTQ questionnaires (d=1.933) and wrist to forearm ratio (WFR) 1 week after completion of intervention.ConclusionsThis pilot study suggests that intraneural facilitation might improve symptoms and possibly function but did not improve median nerve cross-sectional area or WFR in CTS at follow-up evaluation 3 months after completion of intervention.

Dataset Information

Double-blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study.

Publications

Double-blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets