Track topics on Twitter Track topics that are important to you
This is a 28-week, prospective, multicenter, open-label, single arm study to assess the effect of bisoprolol on glycemic level in Type II diabetes mellitus (DM) controlled subjects with hypertension. The hypothesis of study is that there is no change in glycemic level and lipid metabolism as determined by HbA1C using bisoprolol in Type II DM subjects with suboptimal blood pressure (BP) control.
Diabetes mellitus and hypertension are two of the most common chronic conditions, and each predisposes to accelerated atherosclerosis, cardiovascular disease, and death. There has been a concern that β-blocker might have adverse effects in subjects with diabetes on glucose metabolism, but some data shows that highly β-1 selective agents such as bisoprolol are essentially free of metabolic disturbances involving blood sugar, insulin sensitivity and lipids.
This is a prospective, multicenter, single-arm, open-label study to assess the glycemic effect of bisoprolol in Type II DM patient with suboptimal BP control.
After prescreening period, each enrolled subject with type II DM and suboptimal BP control will underwent laboratory test for efficacy and safety measurement. After that, subject will continue his/her usual dosage of antihypertensive medication and bisoprolol will be added.
Subjects will be instructed to continue their diet and level of physical activity and to attempt to maintain current body weight until completion of the study.
Bisoprolol will be titrated upward until a dosage that lowers BP to <130/80 mmHg during the first 2 month of treatment. The maximum dosage of bisoprolol will be 20 mg o.d. Following 6 month of added bisoprolol therapy, all efficacy and safety measurement will be repeated.
The duration of study will be up to 28 weeks for each patient. This will include a 4-week screening and a 24-week treatment period.
- To assess the effect of bisoprolol on glycemic control measured by differences in the change from baseline HbA1C in Type II DM subjects with suboptimal BP control
- To evaluate the effect of bisoprolol as add-on therapy, on blood pressure in Type II DM subjects with suboptimal BP control
- To evaluate the effect of bisoprolol as add-on therapy, on insulin sensitivity as determined by Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
- To evaluate the effect of bisoprolol as add-on therapy, on lipid metabolism as determined by lipid profile in Type II DM subjects with suboptimal BP control
- To evaluate the safety and tolerability of bisoprolol in Type II DM subjects with suboptimal BP control
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:16:01-0400
This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects.
The b.p.m study will be performed to gain the insight in the courses of illness and therapy in subjects, suffering from hypertension and that have elevated heart rate. This study will show...
This is a Phase I, open-label, randomized, 2-period, 2-sequence, crossover study to demonstrate bioequivalence (BE) between the bisoprolol-amlodipine fixed-dose-combination (FDC) tablet (i...
Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice. Type of the program: multicente...
This study aimed to use cardiac magnetic resonance imaging (CMR) to evaluate the efficacy and safety of bisoprolol therapy for boys with Duchenne muscular dystrophy(DMD) and preserved ejec...
Many patients receiving dabigatran treatment might also require bisoprolol therapy. However, there is a possibility that bisoprolol as significant P-glycoprotein inhibitor might interact with dabigatr...
A cohort analysis using UK Clinical Practice Research Datalink (CPRD) was performed to compare the effects of bisoprolol, other β-blockers, and drugs other than β-blockers on the long-term risk of m...
To date, many questions about the extent and cause of pharmacokinetic variability of even the most widely studied and prescribed β1-adrenergic receptor blockers, such as metoprolol and bisoprolol, re...
This review summarizes literature pertaining to the dawning field of therapeutic targeting of mitochondria in hypertension and discusses the potential of these interventions to ameliorate hypertension...
Despite a growing prevalence of hypertension, young adults (18-39-year-olds) have lower hypertension control rates compared with older adults. The purpose of this study was to evaluate the role of soc...
A cardioselective beta-1-adrenergic blocker. It is effective in the management of hypertension and angina pectoris.
A condition in pregnant women with elevated systolic (>140 mm Hg) and diastolic (>90 mm Hg) blood pressure on at least two occasions 6 h apart. HYPERTENSION complicates 8-10% of all pregnancies, generally after 20 weeks of gestation. Gestational hypertension can be divided into several broad categories according to the complexity and associated symptoms, such as EDEMA; PROTEINURIA; SEIZURES; abnormalities in BLOOD COAGULATION and liver functions.
Hypertension due to RENAL ARTERY OBSTRUCTION or compression.
Hypertension that occurs without known cause, or preexisting renal disease. Associated polymorphisms for a number of genes have been identified, including AGT, GNB3, and ECE1. OMIM: 145500
Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.
Nephrology - kidney function
Nephrology is a specialty of medicine and pediatrics that concerns itself with the study of normal kidney function, kidney problems, the treatment of kidney problems and renal replacement therapy (dialysis and kidney transplantation). Systemic conditions...
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. The two main types of diabetes are: type 1 diabetes type 2 diabetes In the UK, diabetes affects approximately 2.9 million people. There are a...