scholarly journals International randomised controlled trial evaluating metabolic syndrome in type 2 diabetic cigarette smokers following switching to combustion-free nicotine delivery systems: the DIASMOKE protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e045396
Author(s):  
Arkadiusz Krysinski ◽  
Cristina Russo ◽  
Sarah John ◽  
Jonathan D Belsey ◽  
Davide Campagna ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Delivery Systems ◽  
Ambulatory Setting ◽  
Cigarette Smokers ◽  
Nicotine Delivery ◽  
Patients With Diabetes ◽  
Type 2 Diabetic

IntroductionReducing exposure to cigarette smoke is an imperative for public health and for patients with diabetes. Increasingly, combustion-free nicotine delivery systems (C-F NDS) such as e-cigarettes and heated tobacco products are substituting conventional cigarettes and accelerating the downward trends in smoking prevalence. However, there is limited information about the long-term health impact in patients with diabetes who use C-F NDS. This randomised trial of type 2 diabetic cigarette smokers will test the hypothesis that following a switch from conventional cigarettes to C-F NDS a measurable improvement in metabolic syndrome (MetS) factors will be shown over the course of 2 years.Methods and analysisThe study is multicentre and thus will take place in five locations in four countries in an ambulatory setting. A total of 576 patients with diabetes will be randomised (1:2 ratio) to either a control arm (Study Arm A), in which they will be offered referral to smoking cessation programmes or to an intervention arm (Study Arm B) assigned to C-F NDS use. Participants will be at least 23 years old and of any gender. Patient recruitment will start in February 2021 and is expected to be completed by December 2021. Primary outcome measures include fasting plasma glucose, blood pressure, triglycerides, high-density lipoprotein and waist circumference, while secondary feature absolute change in the sum of the individual factors of MetS and change in each individual factor of MetS measured at each study time point.Ethics and disseminationThe approval of research ethics committee (REC) regarding the trial protocol, informed consent forms and other relevant documents is required to commence the study. Substantial amendments to the study protocol cannot be implemented until the REC grants a favourable opinion. The results of the study are intended to be published as articles in high quality peer-reviewed journals and disseminated through conference papers.Trial registration numberNCT04231838. Pre-results stage.

scholarly journals International Randomised Controlled Trial evaluating metabolic syndrome in type 2 Diabetic Cigarette Smokers following switching to Combustion-Free Nicotine Delivery Systems: the DIASMOKE protocol

2020 ◽  
Author(s):  
Arkadiusz Krysinski ◽  
Cristina Russo ◽  
Sarah John ◽  
Jonathan Belsey ◽  
Davide Campagna ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Impact ◽  
Diabetic Patients ◽  
Cigarette Smokers ◽  
Nicotine Delivery ◽  
Randomised Controlled ◽  
Type 2 Diabetic

Reducing exposure to cigarette smoke is an imperative for public health, and even more so for diabetic patients. Increasingly, combustion-free technologies for nicotine delivery such as e-cigarettes and heated tobacco products are substituting conventional cigarettes and accelerating the current downward trends in smoking prevalence. However, there is limited information about the long-term health impact in diabetics who use these technologies. This international randomised controlled trial of type 2 diabetic cigarette smokers will test the hypothesis that following a switch from conventional cigarettes to Combustion-Free Nicotine Delivery Systems (C-F NDS), a measurable improvement in metabolic syndrome (MetS) risk factors and functional parameters will be shown over the course of 2 years. A total of 576 patients will be randomized (1:2 ratio) to either a control arm (Study Arm A), in which they will be offered referral to smoking cessation programs or to an intervention arm (Study Arm B), in which they will be assigned to C-F NDS use. The primary outcome will be the prevalence of the a difference in MetS score between baseline and 2 years follow-up, with comparison being made between diabetic patients randomized to each arm of the study. Patient recruitment will start in October 2020 and enrolment is expected to be completed by August 2021. This will be the first study determining the overall health impact of using such technologies in diabetic patients. Data from this study will provide valuable insights into the overall potential of C-F NDS to reduce the risk of cardiovascular disease in individuals, particularly diabetic patients. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04231838

scholarly journals 459 Evaluation of LDL-C reductions by siRNA treatment with inclisiran in patients with diabetes mellitus, metabolic syndrome or neither

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
R. Scott Wright ◽  
David Kallend ◽  
Kausik K Ray ◽  
Lawrence Leiter ◽  
Wolfgang Koenig ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Metabolic Syndrome ◽  
Controlled Trial ◽  
Atherosclerotic Cardiovascular Disease ◽  
Double Blind ◽  
Sirna Treatment ◽  
Patients With Diabetes

Abstract Aims Patients with diabetes (DM) and metabolic syndrome (MS) have elevated risks for atherosclerotic cardiovascular disease (ASCVD). Aggressive LDL-C lowering reduces risks. Inclisiran, a new siRNA, lowers LDL-C and was evaluated in patients with Type 2 diabetes (DM), metabolic syndrome (MS) without DM or neither (N) in the ORION-10 trial. Methods ORION-10 was a double-blind, randomized, placebo controlled trial evaluating inclisiran in 1561 patients with ASCVD on maximally tolerated therapy for lowering LDL-C. 781 inclisiran (INC) participants and 780 placebo (P) patients received 1.5 mL SQ tx at Days 1, 90, then every 6 months until Day 540. We evaluated the time adjusted change in LDL-C from baseline after Days 90–540 in DM (n = 702), MS (n = 455) and N participants (n = 404). Results There were no differences in baseline demographics and background therapies between INC and P. Statins were utilized in 89.8% INC and 88.7% of P. High intensity statins were utilized in 67.2% of INC and 68.8% of P; ezetimibe in 10.2% of NC and 9.5% of P participants. INC reduced LDL-C by − 54.4% (−58.3, −50.6 95% CI) in DM, (P < 0.001), −58.6% (−62.3, −54.8), P < 0.001 in-MS and −56.0% (−60.2, −51.7), in N subjects P < 0.001 (see Figure). Conclusions Inclisiran potently and durably reduces LDL-C across patients with DM, MS and those with neither, demonstrating potent efficacy and durability across glycaemic categories. Inclisiran may also represent a potent LDL-C lowering treatment for those with DM and MS.

Sleep Quality of Diabetic Patients with Metabolic Syndrome, Is There A Difference?

2020 ◽  
Author(s):  
Savas Karatas ◽  
Aysun Işıklar
Keyword(s):  
Metabolic Syndrome ◽  
Sleep Quality ◽  
Diabetic Patients ◽  
Poor Sleep ◽  
Type 2 Diabetic Patients ◽  
Subjective Sleep Quality ◽  
Significant Difference ◽  
Patients With Diabetes ◽  
Type 2 Diabetic

Poor sleep quality is a prevalent health problem among patients with diabetes. Metabolic syndrome (MetS) is common in type 2 diabetic patients and associated with morbidity and mortality. We aimed to investigate sleep quality among type 2 diabetes patients according to their metabolic syndrome status. This was an analysis of data collected from 189 adult type 2 diabetic patients. The patients divided into two groups (metabolic and non-metabolic) based on the presence of MetS. Anthropometric measurements, blood pressure, and serum glucose, lipid levels were collected. The Pittsburgh Sleep Quality Index (PSQI) calculated for all patients. There was no significant difference in subjective sleep quality scores between the two groups (p > 0.05). However, there was a significant difference in sleep latency scores between the two groups; the scores of patients with MetS were lower than those of patients without MetS (p = 0.010, p < 0.05).Sleep quality was low in 57.1% (n = 108) of patients with diabetes. Poor sleep is common among diabetic patients, but in this study, metabolic syndrome existence not associated with sleep quality in type 2 diabetic patients.

Status of antioxidant and lipid peroxidation in type 2 diabetic human subjects diagnosed with and without metabolic syndrome by using NCEP-ATPIII, IDF and WHO criteria

2015 ◽  
Vol 9 (2) ◽  
pp. 158-167 ◽  
Author(s):  
Dhananjay Yadav ◽  
Meerambika Mishra ◽  
Anish Zacharia Joseph ◽  
Senthil Kumar Subramani ◽  
Sunil Mahajan ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Lipid Peroxidation ◽  
Human Subjects ◽  
Who Criteria ◽  
Type 2 Diabetic

scholarly journals E-healthcare for diabetes mellitus type 2 patients – a randomised controlled trial in Slovenia

2017 ◽  
Vol 56 (3) ◽  
pp. 150-157 ◽  
Author(s):  
Rade Iljaž ◽  
Andrej Brodnik ◽  
Tatjana Zrimec ◽  
Iztok Cukjati
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Nurse Practitioners ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Patients With Diabetes ◽  
Randomised Controlled ◽  
Interventional Group

Abstract Background Telemonitoring and web-based interventions are increasingly used in primary-care practices in many countries for more effective management of patients with diabetes mellitus (DM). A new approach in treating patients with diabetes mellitus in family practices, based on ICT use and nurse practitioners, has been introduced and evaluated in this study. Method Fifteen Slovene family practices enrolled 120 DM patients treated only with a diet regime and/or tablets into the study. 58 of them were included into the interventional group, and the other 62 DM patients into the control group, within one-year-long interventional, randomised controlled trial. Patients in the control group had conventional care for DM according to Slovenian professional guidelines, while the patients in the interventional group were using also the eDiabetes application. Patients were randomised through a balanced randomisation process. Results Significant reductions of glycated haemoglobin (HbA1c) values were found after 6 and 12 months among patients using this eDiabetes application (p<0.05). Among these patients, a significant correlation was also found between self-monitored blood pressure and the final HbA1c values. Diabetic patients’ involvement in web-based intervention had only transient impact on their functional health status. Conclusion This eDiabetes application was confirmed to be an innovative approach for better self-management of DM type 2 patients not using insulin. Both a significant reduction of HbA1c values and a significant correlation between the average self-measured blood pressure and the final HbA1c values in the interventional group were found. Nurse practitioners – as diabetes care coordinators – could contribute to better adherence in diabetes e-care.

scholarly journals Adiponectin Concentrations in Type 2 Diabetic Patients with or without Metabolic Syndrome

2008 ◽  
Vol 32 (3) ◽  
pp. 224 ◽  
Author(s):  
Ja Young Park ◽  
Ja Won Kim ◽  
Ji Min Kim ◽  
Ying Han ◽  
Soo Kyung Park ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic
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