scholarly journals Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034883
Author(s):  
Reina Kameda ◽  
Hiroshi Nomoto ◽  
Kyu Yong Cho ◽  
Shinichiro Kawata ◽  
Kazuno Omori ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Medical Information ◽  
Dipeptidyl Peptidase ◽  
University Hospital ◽  
Haemoglobin A1c ◽  
Open Label ◽  
Nocturnal Hypertension ◽  
Parallel Group

IntroductionNocturnal hypertension is clinically important for patients with type 2 diabetes (T2D), considering its strong correlation with cardiovascular events. We aim to test the hypothesis that the sodium-glucose cotransporter 2 inhibitor, luseogliflozin, ameliorates nocturnal hypertension more effectively than a dipeptidyl peptidase (DPP)-4 inhibitor in patients with T2D.Methods and analysisThis study is a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group trial. Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%–9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their DPP-4 inhibitor or to switch to luseogliflozin 2.5 mg once daily for 8 weeks. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) will be performed twice at baseline and at the end of the study. All participants will continue their diet and exercise therapy, and the doses of concomitant medications will not be adjusted during the study. The primary endpoint is the effect of luseogliflozin on the mean change in systolic blood pressure (SBP) during the night, as measured by ABPM. The secondary endpoints are mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1 hour before the next dose, and other laboratory parameters. The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments.Ethics and disseminationThe Ethics Review Board of Hokkaido University Hospital has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numbersThe University Hospital Medical Information Network (UMIN000031451); Japan Registry of Clinical Trials (jRCTs011180019); Pre-results.

scholarly journals Effect of tofogliflozin on arterial stiffness in patients with type 2 diabetes: prespecified sub-analysis of the prospective, randomized, open-label, parallel-group comparative UTOPIA trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Naoto Katakami ◽  
◽  
Tomoya Mita ◽  
Hidenori Yoshii ◽  
Toshihiko Shiraiwa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Conventional Treatment ◽  
Mixed Effects ◽  
Mixed Effects Models ◽  
Open Label ◽  
Parallel Group ◽  
History Of

Abstract Background Tofogliflozin, an SGLT2 inhibitor, is associated with favorable metabolic effects, including improved glycemic control and serum lipid profile and decreased body weight, visceral adipose tissue, and blood pressure (BP). This study evaluated the effects of tofogliflozin on the brachial-ankle pulse wave velocity (baPWV) in patients with type 2 diabetes (T2DM) without a history of apparent cardiovascular disease. Methods The using tofogliflozin for possible better intervention against atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, multicenter, parallel-group, comparative study. As one of the prespecified secondary outcomes, changes in baPWV over 104 weeks were evaluated in 154 individuals (80 in the tofogliflozin group and 74 in the conventional treatment group) who completed baPWV measurement at baseline. Results In a mixed-effects model, the progression in the right, left, and mean baPWV over 104 weeks was significantly attenuated with tofogliflozin compared to that with conventional treatment (– 109.3 [– 184.3, – 34.3] (mean change [95% CI] cm/s, p = 0.005; – 98.3 [– 172.6, – 24.1] cm/s, p = 0.010; – 104.7 [– 177.0, – 32.4] cm/s, p = 0.005, respectively). Similar findings were obtained even after adjusting the mixed-effects models for traditional cardiovascular risk factors, including body mass index (BMI), glycated hemoglobin (HbA1c), total cholesterol, high-density lipoprotein (HDL)-cholesterol, triglyceride, systolic blood pressure (SBP), hypertension, smoking, and/or administration of drugs, including hypoglycemic agents, antihypertensive agents, statins, and anti-platelets, at baseline. The findings of the analysis of covariance (ANCOVA) models, which included the treatment group, baseline baPWV, and traditional cardiovascular risk factors, resembled those generated by the mixed-effects models. Conclusions Tofogliflozin significantly inhibited the increased baPWV in patients with T2DM without a history of apparent cardiovascular disease, suggesting that tofogliflozin suppressed the progression of arterial stiffness. Trial Registration UMIN000017607. Registered 18 May 2015. (https://www.umin.ac.jp/icdr/index.html)

scholarly journals TYPE 2 DIABETES MELLITUS;

2013 ◽  
Vol 20 (02) ◽  
pp. 237-243
Author(s):  
GHULAM HUSSAIN BALOCH ◽  
ABDUL QADIR DALL ◽  
ATIF SITWAT HAYAT ◽  
Syed Zulfiquar Ali Shah ◽  
Bikha Ram Devrajani
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
University Hospital ◽  
Diabetic Patients ◽  
Haemoglobin A1c ◽  
Type 2 Diabetic Patients ◽  
History Of ◽  
Upper Molar

Objective: To determine the frequency and pattern of dental carries in patients with type 2 diabetes mellitus. Design: Crosssectional descriptive study. Patients and methods: Patients with history of type 2 diabetes mellitus for ≥ 02 years duration with ≥ 35 years ofage and of either gender with dental pain visit at medical and dental outpatient department (OPD) of Liaquat University Hospital Hyderabad.The detail history was taken and the blood samples were taken for haemoglobin A1c (HbA1c) to assess the glycemic status. The existenceof dental carries and its pattern was diagnosed through dental examination by consultant dentist had clinical experience ≥05 years. The datawas collected on pre-designed proforma, entered and analyzed in SPSS version 11.00. Results: A total of 137 type 2 diabetic patients wereselected for this study, out of these 82 were males and 55 females. The dental carries was found in 98 (71.5%) patients. Out of these ninetyeight, 53 (54.08%) were males and 45 (45.92%) were female. Upper molar teeth involvement was present in 46 patients and lower molarteeth were involved in 52 patients. Dentine carries was seen in 35 patients, enamel carries in 19, white spot carries in 20 patients, pulpitis in16 patients, and pulp capping in 8 patients. Involvement of individual teeth was also assessed, the upper molar involvement was present in32 patients, premolar involvement was present in 11, incisor involvement in 03 patients. The lower molars were involved in 28 patients,lower pre molar in 21 and lower incisors in 03 patients. Dental carries was present in 43 (43.9%) patients in patients whose duration ofdiabetes was between 5-10 years, whereas those patients having duration >10 years had 31.6% frequency of dental carries, whileregarding duration of <5 years only 24 (24.5%) patients had dental carries. Conclusions: The diabetic patients are more prone to acquiredental caries.

scholarly journals Novel Urinary Glycan Biomarkers Predict Cardiovascular Events in Patients With Type 2 Diabetes: A Multicenter Prospective Study With 5-Year Follow Up (U-CARE Study 2)

2021 ◽  
Vol 8 ◽  
Author(s):  
Koki Mise ◽  
Mariko Imamura ◽  
Satoshi Yamaguchi ◽  
Mayu Watanabe ◽  
Chigusa Higuchi ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Medical Information ◽  
Information Criterion ◽  
Cox Proportional Hazards ◽  
University Hospital ◽  
Net Reclassification Improvement ◽  
Patients With Diabetes ◽  
High Mannose

Background: Although various biomarkers predict cardiovascular event (CVE) in patients with diabetes, the relationship of urinary glycan profile with CVE in patients with diabetes remains unclear.Methods: Among 680 patients with type 2 diabetes, we examined the baseline urinary glycan signals binding to 45 lectins with different specificities. Primary outcome was defined as CVE including cardiovascular disease, stroke, and peripheral arterial disease.Results: During approximately a 5-year follow-up period, 62 patients reached the endpoint. Cox proportional hazards analysis revealed that urinary glycan signals binding to two lectins were significantly associated with the outcome after adjustment for known indicators of CVE and for false discovery rate, as well as increased model fitness. Hazard ratios for these lectins (+1 SD for the glycan index) were UDA (recognizing glycan: mixture of Man5 to Man9): 1.78 (95% CI: 1.24–2.55, P = 0.002) and Calsepa [High-Man (Man2–6)]: 1.56 (1.19–2.04, P = 0.001). Common glycan binding to these lectins was high-mannose type of N-glycans. Moreover, adding glycan index for UDA to a model including known confounders improved the outcome prediction [Difference of Harrel's C-index: 0.028 (95% CI: 0.001–0.055, P = 0.044), net reclassification improvement at 5-year risk increased by 0.368 (0.045–0.692, P = 0.026), and the Akaike information criterion and Bayesian information criterion decreased from 725.7 to 716.5, and 761.8 to 757.2, respectively].Conclusion: The urinary excretion of high-mannose glycan may be a valuable biomarker for improving prediction of CVE in patients with type 2 diabetes, and provides the rationale to explore the mechanism underlying abnormal N-glycosylation occurring in patients with diabetes at higher risk of CVE.Trial Registration: This study was registered with the University Hospital Medical Information Network on June 26, 2012 (Clinical trial number: UMIN000011525, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013482).

scholarly journals Influence of Bromocriptine Plus Metformin Treatment on Glycaemia and Blood Pressure in Patients with Type 2 Diabetes Mellitus

2018 ◽  
Vol 25 (1) ◽  
pp. 59-66
Author(s):  
Alfredo Briones-Aranda ◽  
Javier Ramírez-Carballo ◽  
Bernardo Alfredo Romero Gómez ◽  
Victor Manuel Vega Villa ◽  
Manuela Castellanos Pérez ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Controlled Trial ◽  
Combined Therapy ◽  
The Body ◽  
Open Label ◽  
D2 Agonist

Abstract Background and aims: Bromocriptine is a dopaminergic (D2) agonist that has shown hypoglycemic and normotensive activity in preclinical and clinical studies. The main objective of this study was to investigate the effect of bromocriptine plus metformin on glycaemia and blood pressure in patients with type 2 diabetes mellitus (T2DM). Material and methods: An open-label randomised controlled trial was conducted for three months. It involved two groups (n=10), each containing 2 women and 8 men with an average age of 50 years. One group was given monotherapy (MT) with metformin (850 mg every 12 h) and the other combined therapy (CT) with the same dose of metformin plus an increasing dose of bromocriptine (from 1.25 mg per day to 2.5 mg per day). The parameters monitored were glycaemia, glycated hemoglobin (HbA1c), serum creatinine, blood pressure, and the body mass index. Results: CT was able to significantly decrease the level of glycaemia, HbA1c and diastolic blood pressure, whereas MT had no effect on any of the measured variables. Conclusions: The ability of CT with bromocriptine and metformin to control glycaemia and produce a normotensive effect reaffirms its advantages for controlling T2DM. Further research is needed to improve this therapeutic strategy.

scholarly journals Study protocol: a prospective controlled clinical trial to assess surgical or medical treatment for paediatric type 2 diabetes (ST2OMP)

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047766
Author(s):  
Amy S Shah ◽  
Michael A Helmrath ◽  
Thomas H Inge ◽  
Stavra A Xanthakos ◽  
Megan M Kelsey ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Medical Treatment ◽  
Medical Center ◽  
Institutional Review Boards ◽  
Controlled Clinical Trial ◽  
Haemoglobin A1c ◽  
Open Label ◽  
Beneficial Effects

IntroductionThe pathophysiology of type 2 diabetes (T2D) in youth differs from adults and conventional medical treatment approaches with lifestyle change, metformin, thiazolidinediones or insulin are inadequate. Metabolic bariatric surgery (MBS) improves multiple health outcomes in adults with T2D. Initial small, uncontrolled studies of Roux-en-Y gastric bypass have also suggested beneficial effects in adolescents. Definitive studies in youth with T2D are lacking, especially with the now more common form of MBS, vertical sleeve gastrectomy (VSG). The surgical or medical treatment for paediatric type 2 diabetes (ST2OMP) clinical trial was designed to test the hypothesis that VSG will more effectively reduce hyperglycaemic and diabetes comorbidities than the best currently available medical treatment incorporating state of the art pharmacotherapies. ST2OMP is also designed to better understand the pancreatic and enterohepatic mechanisms by which MBS improves diabetes and its associated comorbidities.Methods and analysisST2OMP is a prospective, open-label, controlled clinical trial that will recruit 90 postpubertal participants, age range 13–19.9 years, with body mass index ≥35 kg/m2 or >120% of 95th percentile and youth-onset T2D. The primary outcome is the per cent of youth achieving haemoglobin A1c <6.0% at 12 months postgroup allocation (post-VSG vs postmedical group allocation). Secondary outcomes include remission of comorbidities and measures of β-cell and incretin responses at 12 and 24 months post VSG versus AMT.Ethics and disseminationThe ST2OMP protocol was approved by the Cincinnati Children’s Hospital Medical Center and the University of Colorado Institutional Review Boards. Written informed consent is obtained prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberClinical Trials.Gov NCT04128995.

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