scholarly journals Efficacy of dulaglutide to improve Vascular Health indexes in subjects with Type 2 Diabetes: A Randomized Trial

2020 ◽  
Author(s):  
Antonino Tuttolomondo ◽  
Anna Cirrincione ◽  
Alessandra Casuccio ◽  
Alessandro Del Cuore ◽  
Mario Daidone ◽  
...  
Keyword(s):  
Arterial Stiffness ◽  
Endothelial Function ◽  
Ldl Cholesterol ◽  
Lower Percentage ◽  
Total Serum ◽  
Total Serum Cholesterol ◽  
Surrogate Markers ◽  
Vascular Health

Abstract Background: Recent cardiovascular outcome trials have shown significant reductions of major cardiovascular (CV) events with glucagon-like peptide (GLP)-1 receptor agonists. Adjunctive surrogates for cardiovascular risk more recently validated by some studies (23,24) are arterial stiffness and endothelial function indexes. No randomized trials have yet addressed the possible effects of antidiabetic interventional drugs such as GLP1 agonists on endothelial and arterial stiffness indexes as surrogate markers of vascular damageAims: A randomized trial to once-weekly dulaglutide (1.5 mg) added to traditional antidiabetic treatment compared to traditional treatment alone to evaluate some metabolic efficacy endpoints and surrogate vascular efficacy endpoints such as endothelial function and arterial stiffness indexes.Methods: Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA1c was 9.5% or less on stable doses of up to two oral glucose­lowering drugs with or without basal insulin therapy were eligible. Subcutaneous dulaglutide was initiated at the full dose (1.5 mg/day weekly). Arterial stiffness indexes (pulse wave velocity and augmentation index) and endothelial function index (reactive hyperemia index) were evaluated at baseline and at a three-month and nine-month examination visit. At each visit (at 3 and 9 month follow-up) were also evaluated glycemic variables such as fasting plasma glucose (FPG), HbA1c and lipid variables such as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride. Results: at a three month follow up subjects treated with dulaglutide in comparison with subjects treated with conventional therapy showed significantly lower serum levels of FBG and significantly lower percentage of HBa1c. At a 9 month follow up subjects treated with dulaglutide in comparison with control subjects treated with conventional therapy showed a significant lowering of diastolic blood pressure, BMI, mean total serum cholesterol, LDL cholesterol, FPGa significantly lower percentage of HBa1C and PWV and higher mean RHI values.Discussion: These findings are consistent with previous studies indicating the strict relationship between cardiovascular risk factors such as systolic blood pressure, total serum cholesterol and LDL levels and cardiovascular events and vascular health surrogate markers.

scholarly journals Efficacy of dulaglutide on vascular health indexes in subjects with type 2 diabetes: A randomized trial.

2020 ◽  
Author(s):  
Antonino Tuttolomondo ◽  
Anna Cirrincione ◽  
Alessandra Casuccio ◽  
Alessandro Del Cuore ◽  
Mario Daidone ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Arterial Stiffness ◽  
Endothelial Function ◽  
Randomized Trial ◽  
Conventional Therapy ◽  
Total Serum ◽  
Total Serum Cholesterol ◽  
Vascular Health ◽  
Antidiabetic Treatment

Abstract Background: Recent cardiovascular outcome trials have shown significant reductions in major cardiovascular (CV) events with glucagon-like peptide (GLP)-1 receptor agonists. Additionally, adjunctive surrogates for cardiovascular risk validated by some studies include arterial stiffness and endothelial function indexes. To date, no randomized trial has addressed the possible effects of antidiabetic interventional drugs such as GLP1 agonists on endothelial and arterial stiffness indexes as surrogate markers of vascular damage. Aims: We aimed to evaluate metabolic efficacy and surrogate vascular efficacy endpoints of once-weekly dulaglutide (1.5 mg) plus traditiona antidiabetic treatment compared with traditional antidiabetic treatment alone in subjects with type 2 diabetes. Methods: Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA1c level was 9.5% or less on stable doses of up to two oral glucose­lowering drugs with or without basal insulin therapy were eligible for randomization. Subcutaneous dulaglutide was initiated at the full dose (1.5 mg/day weekly). Arterial stiffness (PWV: pulse wave velocity and augmentation index) and endothelial function (RHI: reactive hyperaemia index) were evaluated at baseline and at three-month and nine-month examination visits. At each visit (at 3 and 9 months), the subjects were also evaluated for glycaemic variables such as fasting plasma glucose (FPG) and HbA1c and lipid variables such as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels. Results: At the three-month follow-up, the subjects treated with dulaglutide showed significantly lower serum levels of FPG and HbA1c than control subjects treated with conventional therapy. At the 9-month follow-up, subjects treated with dulaglutide showed significant lower values of the mean diastolic blood pressure, BMI, total serum cholesterol, LDL cholesterol, FPG, HbA1c and PWV and higher mean RHI values than control subjects treated with conventional therapy . Conclusions: Our randomized trial showed that subjects with type 2 diabetes treated with conventional therapy plus 1.5 mg/day of subcutaneous dulaglutide compared with subjects treated with conventional therapy alone showed favourable metabolic effects associated with positive effects on vascular health markers such as arterial stiffness and endothelial function markers. These findings are consistent with previous study findings indicating the strict relationship between cardiovascular risk factors such as systolic blood pressure, total serum cholesterol and LDL levels and cardiovascular events and vascular health surrogate markers.

scholarly journals Efficacy of dulaglutide on vascular health indexes in subjects with type 2 diabetes: a randomized trial

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Antonino Tuttolomondo ◽  
Anna Cirrincione ◽  
Alessandra Casuccio ◽  
Alessandro Del Cuore ◽  
Mario Daidone ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Arterial Stiffness ◽  
Endothelial Function ◽  
Randomized Trial ◽  
Conventional Therapy ◽  
Total Serum ◽  
Total Serum Cholesterol ◽  
Vascular Health ◽  
Antidiabetic Treatment

Abstract Background Recent cardiovascular outcome trials have shown significant reductions in major cardiovascular (CV) events with glucagon-like peptide (GLP)-1 receptor agonists. Additionally, adjunctive surrogates for cardiovascular risk validated by some studies include arterial stiffness and endothelial function indexes. To date, no randomized trial has addressed the possible effects of antidiabetic interventional drugs such as GLP1 agonists on endothelial and arterial stiffness indexes as surrogate markers of vascular damage. Aims We aimed to evaluate metabolic efficacy and surrogate vascular efficacy endpoints of once-weekly dulaglutide (1.5 mg) plus traditional antidiabetic treatment compared with traditional antidiabetic treatment alone in subjects with type 2 diabetes. Methods Men and women (aged ≥ 50 years) with established or newly detected type 2 diabetes whose HbA1c level was 9.5% or less on stable doses of up to two oral glucose­ lowering drugs with or without basal insulin therapy were eligible for randomization. Subcutaneous dulaglutide was initiated at the full dose (1.5 mg/day weekly). Arterial stiffness (PWV: pulse wave velocity and augmentation index) and endothelial function (RHI: reactive hyperaemia index) were evaluated at baseline and at three-month and nine-month examination visits. At each visit (at 3 and 9 months), the subjects were also evaluated for glycaemic variables such as fasting plasma glucose (FPG) and HbA1c and lipid variables such as total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride levels. Results At the three-month follow-up, the subjects treated with dulaglutide showed significantly lower serum levels of FPG and HbA1c than control subjects treated with conventional therapy. At the 9-month follow-up, subjects treated with dulaglutide showed significant lower values of the mean diastolic blood pressure, BMI, total serum cholesterol, LDL cholesterol, FPG, HbA1c and PWV and higher mean RHI values than control subjects treated with conventional therapy. Conclusions Our randomized trial showed that subjects with type 2 diabetes treated with conventional therapy plus 1.5 mg/day of subcutaneous dulaglutide compared with subjects treated with conventional therapy alone showed favourable metabolic effects associated with positive effects on vascular health markers such as arterial stiffness and endothelial function markers. These findings are consistent with previous study findings indicating the strict relationship between cardiovascular risk factors such as systolic blood pressure, total serum cholesterol and LDL levels and cardiovascular events and vascular health surrogate markers.

P0226CONSEQUENCES OF SUPRAPHYSIOLOGICAL DYALYSATE MAGNESIUM CONCENTRATION ON ARTERIAL STIFFNESS, HEMODYNAMIC PROFILE AND ENDOTHELIAL FUNCTION IN HEMODIALYSIS: A RANDOMIZED CROSS-OVER STUDY AND FOLLOW-UP

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Rosaria Del Giorno ◽  
Soraya Lavorato ◽  
Kevyn Stefanelli ◽  
Giampiero Allegra ◽  
Claudia Zapparoli ◽  
...  
Keyword(s):  
Arterial Stiffness ◽  
Endothelial Function ◽  
Clinical Outcomes ◽  
Vascular Stiffness ◽  
Magnesium Concentration ◽  
Maintenance Hemodialysis ◽  
Total Serum ◽  
Hemodynamic Profile

Abstract Background and Aims Increasing dialysate magnesium improves vascular stiffness in subjects undergoing maintenance hemodialysis. The present findings merit a larger trial to evaluate the effects of a 0.75 mmol/L D-Mg2+ on major clinical outcomes. Method A randomized 4-week cross-over study aimed at investigating the consequences of increasing D-Mg2+ from 0.50 to 0.75 mmol/L on arterial stiffness, hemodynamic profile, and endothelial function in subjects undergoing hemodialysis. The long-term effect of higher D-Mg2+ on mineral metabolism markers was investigated in a six-month follow-up. Data were analysed by linear mixed models for repeated measures. Results Pulse wave velocity and pulse pressure significantly decreased on the higher D-Mg2+ compared with the standard one by -0.91 m/sec (95% confidence interval: -1.52 to -0.29; p=0.01) and -9.61 mmHg (-18.89 to -0.33, p=0.04), respectively. A significant reduction in systolic blood pressure of -12.96 mmHg (-24.71 to -1.22, p=0.03) was also observed. No period or carryover effects were observed. During the long-term follow-up the higher D-Mg2+ significantly increased total serum and ionized Mg (mean percentage change from baseline to follow-up +21%; and + 27%; p≤0.001 for both), while parathormone (PTH) decreased significantly (-11%, p=0.03). Conclusion Increasing dialysate magnesium improves vascular stiffness in subjects undergoing maintenance hemodialysis. The present findings merit a larger trial to evaluate the effects of a 0.75 mmol/L D-Mg2+ on major clinical outcomes.

scholarly journals Effect of interventions with ingestion of legumes and/or supervised exercise on the lipid profile of young, healthy sedentary women

2010 ◽  
pp. 224-234 ◽  
Author(s):  
Luis F. Fajardo ◽  
Dora G. Castellanos ◽  
Myriam Chinchilla ◽  
Luz N. Vargas ◽  
Martha Guerra ◽  
...  
Keyword(s):  
Lipid Profile ◽  
Life Style ◽  
Ldl Cholesterol ◽  
Hdl Cholesterol ◽  
Serum Levels ◽  
Total Serum ◽  
Total Serum Cholesterol ◽  
Supervised Exercise ◽  
Healthy Life Style ◽  
Sedentary Women

Objective: To contribute to the knowledge of some aspects of the Healthy Life Style by studying the effects of including legumes in the diet and exercise at two intensity levels, along with the lipid profile of young sedentary women living at 2640 meters above sea level. Materials and methods: The study included a non-randomized clinical trial with four intervention groups: exercise at 45% VO2 peak plus legumes in diet, exercise at 65% VO2 peak plus legumes in diet, only exercise at 65% VO2 peak, and only inclusion of legumes in diet. In each group, 20 to 23 sedentary women were included. The intervention was carried out for four weeks, three days a week. Exercise prescription was based on measurement of VO2 peak by ergospirometry; and the current intervention was monitored with heart-rate monitors. The outcome variables were total serum cholesterol, LDL cholesterol, HDL cholesterol, and triacylglycerols measured at baseline and after two and four weeks of intervention. Results: The measurements taken of participants in the group of exercise at 65% VO2 peak plus legumes in diet showed a reduction of 19.8 mg/dl in total cholesterol, of 21.8 mg/dl of LDL cholesterol, of 20.7 mg/dl of tracylglycerol, and an increase of 6.2 mg/dl of HDL cholesterol. The serum levels of HDL also increased in the group of only exercise at 65% VO2 peak. No significant changes in serum levels were documented for participants in the group with only dietary modifications. Conclusions: The results suggest that different interventions that meet some of the criteria for healthy eating and life style show different effects with regards to the level of change in the lipid profile components.

Fenofibrate improves endothelial function in the brachial artery and forearm resistance arterioles of statin-treated Type 2 diabetic patients

2010 ◽  
Vol 118 (10) ◽  
pp. 607-615 ◽  
Author(s):  
Sandra J. Hamilton ◽  
Gerard T. Chew ◽  
Timothy M.E. Davis ◽  
Gerald F. Watts
Keyword(s):  
Endothelial Dysfunction ◽  
Endothelial Function ◽  
Statin Therapy ◽  
Brachial Artery ◽  
Ldl Cholesterol ◽  
Density Lipoprotein ◽  
Diabetic Patients ◽  
Type 2 Diabetic Patients ◽  
Type 2 Diabetic

Dyslipidaemia contributes to endothelial dysfunction and CVD (cardiovascular disease) in Type 2 diabetes mellitus. While statin therapy reduces CVD in these patients, residual risk remains high. Fenofibrate corrects atherogenic dyslipidaemia, but it is unclear whether adding fenofibrate to statin therapy lowers CVD risk. We investigated whether fenofibrate improves endothelial dysfunction in statin-treated Type 2 diabetic patients. In a cross-over study, 15 statin-treated Type 2 diabetic patients, with LDL (low-density lipoprotein)-cholesterol <2.6 mmol/l and endothelial dysfunction [brachial artery FMD (flow-mediated dilatation) <6.0%] were randomized, double-blind, to fenofibrate 145 mg/day or matching placebo for 12 weeks, with 4 weeks washout between treatment periods. Brachial artery FMD and endothelium-independent NMD (nitrate-mediated dilatation) were measured by ultrasonography at the start and end of each treatment period. PIFBF (post-ischaemic forearm blood flow), a measure of microcirculatory endothelial function, and serum lipids, lipoproteins and apo (apolipoprotein) concentrations were also measured. Compared with placebo, fenofibrate increased FMD (mean absolute 2.1±0.6 compared with −0.3±0.6%, P=0.04), but did not alter NMD (P=0.75). Fenofibrate also increased maximal PIFBF {median 3.5 [IQR (interquartile range) 5.8] compared with 0.3 (2.1) ml/100 ml/min, P=0.001} and flow debt repayment [median 1.0 (IQR 3.5) compared with −1.5 (3.0) ml/100 ml, P=0.01]. Fenofibrate lowered serum cholesterol, triacylgycerols (triglycerides), LDL-cholesterol, apoB-100 and apoC-III (P≤0.03), but did not alter HDL (high-density lipoprotein)-cholesterol or apoA-I. Improvement in FMD was inversely associated with on-treatment LDL-cholesterol (r=−0.61, P=0.02) and apoB-100 (r=−0.54, P=0.04) concentrations. Fenofibrate improves endothelial dysfunction in statin-treated Type 2 diabetic patients. This may relate partly to enhanced reduction in LDL-cholesterol and apoB-100 concentrations.

[34] ENDOTHELIAL FUNCTION IS ASSOCIATED WITH ARTERIAL STIFFNESS IN SUBJECTS WITH TYPE 2 DIABETES

2009 ◽  
Vol 19 ◽  
pp. S9
Author(s):  
G. Daniele ◽  
L. Ghiadoni ◽  
R. Bruno ◽  
C. Bianchi ◽  
L. Pucci ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Arterial Stiffness ◽  
Endothelial Function

Effect of vildagliptin versus glibenclamide on endothelial function and arterial stiffness in patients with type 2 diabetes and hypertension: a randomized controlled trial

2018 ◽  
Vol 55 (12) ◽  
pp. 1237-1245 ◽  
Author(s):  
Luciana Neves Cosenso-Martin ◽  
Luiz Tadeu Giollo-Júnior ◽  
Letícia Aparecida Barufi Fernandes ◽  
Cláudia Bernardi Cesarino ◽  
Marcelo Arruda Nakazone ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Arterial Stiffness ◽  
Endothelial Function ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Return-to-Function Following Treatment of Dupuytren Contracture With Collagenase Clostridium Histolyticum Versus Fasciectomy

Hand ◽  
2020 ◽  
pp. 155894472091992
Author(s):  
Victoria M. Divino ◽  
Mitch DeKoven ◽  
David Hurley
Keyword(s):  
Opioid Analgesics ◽  
Lower Percentage ◽  
Surrogate Markers ◽  
Collagenase Clostridium Histolyticum ◽  
Clostridium Histolyticum ◽  
Inflammatory Drugs ◽  
Dupuytren Contracture ◽  
The Mean ◽  
Analgesic Use

Background: Dupuytren contracture (DC) treatment with collagenase clostridium histolyticum (CCH) has lower associated treatment costs than fasciectomy, but real-world, postprocedure return-to-function data are limited. Methods: This retrospective study used a US claims database and included adults treated for DC with CCH or fasciectomy (first treatment = index date), who had continuous health plan enrollment ≥360 days preindex and ≥90 days postindex (ie, 90-day follow-up). Analgesic use and physical therapy (PT) and occupational therapy (OT) visits during the follow-up were used as surrogate markers for return-to-function. Results: Overall, 1654 and 2745 patients were included in the CCH and fasciectomy cohorts, respectively. A significantly lower percentage of patients in the CCH versus fasciectomy cohort used opioid analgesics (32.3% vs 82.7%; P < .0001), used nonsteroidal anti-inflammatory drugs (8.6% vs 17.2%; P < .0001), or had ≥1 DC-specific PT or OT visit during follow-up (PT, 38.9% vs 45.3% [ P < .0001]; OT, 32.8% vs 38.0% [ P = .0006]). The mean number of DC-specific PT and OT visits (PT, 2.5 vs 6.4 [ P < .0001]; OT, 1.4 vs 1.9 [ P < .0001]) per patient was significantly lower in the CCH versus fasciectomy cohort. Conclusions: This analysis using surrogate markers suggests that CCH treatment may allow earlier return-to-function than fasciectomy in adults treated for DC.

scholarly journals Combined effect ofLactobacillus acidophilusandβ-cyclodextrin on serum cholesterol in pigs

2015 ◽  
Vol 115 (1) ◽  
pp. 1-5 ◽  
Author(s):  
L. Alonso ◽  
J. Fontecha ◽  
P. Cuesta
Keyword(s):  
Treatment Group ◽  
Serum Cholesterol ◽  
Ldl Cholesterol ◽  
Combined Treatment ◽  
Combined Effect ◽  
Total Serum ◽  
Control Group ◽  
Total Serum Cholesterol ◽  
Treatment Groups ◽  
The Individual

AbstractA total of twenty-four Yorkshire gilt pigs of 6–7 weeks of age were used in a 2×2 factorial experiment to determine the individual and combined effects of the inclusion of two dietary factors (cholesterol rich, 3 %β-cyclodextrin (BCD) andLactobacillus acidophiluscultures) on total cholesterol and LDL-cholesterol levels in blood serum. Pigs were assigned randomly to treatment groups (n6). Total serum cholesterol concentrations decreased after 3 weeks in all the experimental treatment groups, including diets with BCD,L.acidophilusor both. Similar trends were observed for serum LDL-cholesterol concentrations among the experimental treatments. No statistically significant differences from the control group were observed in either total serum cholesterol or LDL-cholesterol concentrations (P<0·05) for each of the individual treatment groups: BCD orL.acidophilus. However, significant differences in total serum cholesterol concentrations were observed when comparing the combined treatment group (BCD andL.acidophilus) with the control group, which consisted of a basal diet and sterile milk. The combined treatment group exhibited 17·9 % lower total serum cholesterol concentration after 3 weeks. Similar significant differences were observed when comparing the combined effect experimental group with the control group after 3 weeks. The combined treatment group exhibited 27·9 % lower serum LDL-cholesterol concentrations.

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