scholarly journals Effect of Low-Dose Tadalafil Once Daily On Glycemic Control In Patients With Type 2 Diabetes and Erectile Dysfunction: A Randomized, Double-blind, Placebo-controlled Pilot Study

2021 ◽  
Author(s):  
Min-Kyung Lee ◽  
Jae-Hyuk Lee ◽  
Seo-Young Sohn ◽  
Seo Yeon Lee ◽  
Tae-Yoong Jeong ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Erectile Dysfunction ◽  
Placebo Group ◽  
Pilot Study ◽  
Erectile Function ◽  
Hba1c Level ◽  
Low Dose ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Background: Phosphodiesterase type 5 inhibitors restore nitric oxide signaling, which plays a significant role in erectile function and appears to counteract insulin resistance in animal and human models. This study was aimed to evaluate the glycemic and metabolic effects of low-dose tadalafil once a day in patients with type 2 diabetes and erectile dysfunction.Methods: A 6-month, randomized, double-blind, placebo-controlled pilot trial was conducted. Eligible patients were randomly assigned in a ratio of 2:1 to the tadalafil 5 mg and placebo groups; all patients received either tadalafil or placebo once a day. The primary efficacy endpoint was the change in the glycated hemoglobin (HbA1c) level during the 6-month study period. The secondary efficacy endpoints included metabolic parameters and erectile function. Results: Of the 68 patients who completed this study, 45 and 23 patients were allocated in the tadalafil and placebo groups, respectively. The mean HbA1c level was significantly different between the groups over the 6-month study period (P = 0.021). After 6 months of treatment, the HbA1c decrement in the tadalafil group was greater than that in the placebo group (-0.14% ± 0.53% vs. 0.20% ± 0.69%, P = 0.030). The improvement in the International Index of Erectile Function-5 scores were significantly greater in the tadalafil group than in the placebo group at 6 months (P = 0.003). Conclusion: This prospective pilot study shows that low-dose tadalafil once a day is effective in improving glycemic control and erectile function in patients with type 2 diabetes and erectile dysfunction.Trial Registration: KCT0005666

scholarly journals Effects of a multispecies synbiotic on glucose metabolism, lipid marker, gut microbiome composition, gut permeability, and quality of life in diabesity: a randomized, double-blind, placebo-controlled pilot study

2019 ◽  
Vol 59 (7) ◽  
pp. 2969-2983 ◽  
Author(s):  
Angela Horvath ◽  
Bettina Leber ◽  
Nicole Feldbacher ◽  
Norbert Tripolt ◽  
Florian Rainer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Type 2 Diabetes ◽  
Pilot Study ◽  
Glucose Metabolism ◽  
Life Assessment ◽  
Gut Permeability ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Purpose Diabesity, the combination of obesity and type 2 diabetes, is an ever-growing global health burden. Diabesity-associated dysbiosis of the intestinal microbiome has gained attention as a potential driver of disease and, therefore, a possible therapeutic target by means of pro- or prebiotic supplementation. This study tested the effects of a multispecies synbiotic (i.e. a combination of probiotics and prebiotics) on glucose metabolism, gut microbiota, gut permeability, neutrophil function and quality of life in treatment-experienced diabesity patients. Methods A randomized, double-blind, placebo-controlled pilot study with 26 diabesity patients was conducted in which patients received a daily dose of a multispecies probiotic and a prebiotic (or a placebo) for 6 months. Results There were no changes in glucose metabolism or mixed meal tolerance test responses throughout the study. The analysis of secondary outcomes revealed beneficial effects on hip circumference [− 1 (95% CI − 4; 3) vs +3 (− 1; 8) cm, synbiotics vs. placebo, respectively, p = 0.04], serum zonulin [− 0.04 (− 0.2; 0.1) vs +0.3 (− 0.05; 0.6) ng/ml, p = 0.004)] and the physical role item of the SF36 quality of life assessment [+ 5.4 (− 1.7; 12.5) vs − 5.0 (− 10.1; 0.2) points, p = 0.02] after 3 months of intervention, and lipoprotein (a) [− 2.1 (− 5.7; 1.6) vs +3.4 (− 0.9; 7.9) mg/dl, p = 0.02] after 6 months. There were no significant differences in alpha or beta diversity of the microbiome between groups or time points. Conclusions Glucose metabolism as the primary outcome was unchanged during the intervention with a multispecies synbiotic in patients with diabesity. Nevertheless, synbiotics improved some symptoms and biomarkers of type 2 diabetes and aspects of quality of life suggesting a potential role as adjuvant tool in the management of diabesity. Graphic abstract

Effects of Curcuminoids Plus Piperine on Glycemic, Hepatic and Inflammatory Biomarkers in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blind Placebo-Controlled Trial

Drug Research ◽  
2018 ◽  
Vol 68 (07) ◽  
pp. 403-409 ◽  
Author(s):  
Yunes Panahi ◽  
Nahid Khalili ◽  
Ebrahim Sahebi ◽  
Soha Namazi ◽  
Luis Simental-Mendía ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Placebo Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Inflammatory Biomarkers ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Hs Crp ◽  
The Impact

Abstract Introduction Curcuminoids have been shown to reduce glycemia and related complications in diabetes. In the present study, we evaluated the impact of curcuminoids plus piperine administration on glycemic, hepatic and inflammatory biomarkers in type 2 diabetes (T2D) patients. Methods T2D patients aged 18–65 years were enrolled in a randomized double-blind placebo-controlled trial and randomly allocated to standard-of-care treatment and dietary advises plus either curcuminoids (daily dose of 500 mg/day co-administered with piperine 5 mg/day) or placebo for a period of 3 months. Glycemic, hepatic and inflammatory parameters were measured at baseline and final conditions. Results A total of 100 subjects (50 in each group) completed the 3-month period of trial. A significant reduction was found in serum levels of glucose (−9±16 mg/dL vs. −3±11 mg/dL in curcuminoids and placebo groups, respectively; p=0.048), C-peptide (−0.6±0.8 ng/mL vs. 0.02±0.6 ng/mL; p<0.001) and HbA1c (−0.9±1.1% vs. −0.2±0.5%; p<0.001) after curcuminoids supplementation versus placebo group. Additionally, participants in the intervention group showed lower serum alanine aminotransferase (−2±6 vs. −1±5; p=0.032) and aspartate aminotransferase (−3±5 vs. −0.3±4; p=0.002) levels compared with the placebo group. Finally, no significant differences in high-sensitivity C-reactive protein (hs-CRP) concentrations were observed between curcuminoids and placebo groups (p>0.05). Conclusion The results of the present trial revealed a beneficial effect of curcuminoids plus piperine supplementation on glycemic and hepatic parameters but not on hs-CRP levels in T2D patients.

scholarly journals Six months of daily treatment with vardenafil improves parameters of endothelial inflammation and of hypogonadism in male patients with type 2 diabetes and erectile dysfunction: a randomized, double-blind, prospective trial

2016 ◽  
Vol 174 (4) ◽  
pp. 513-522 ◽  
Author(s):  
Daniele Santi ◽  
Antonio R M Granata ◽  
Alessandro Guidi ◽  
Elisa Pignatti ◽  
Tommaso Trenti ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Erectile Dysfunction ◽  
Erectile Function ◽  
Chronic Treatment ◽  
Double Blind ◽  
Phosphodiesterase Type 5 Inhibitors ◽  
Testosterone Levels ◽  
Male Patients

ObjectiveType 2 diabetes mellitus (T2DM) is associated with endothelial dysfunction, characterized by a reduction of nitric oxide (NO)-mediated relaxation. Phosphodiesterase type 5 inhibitors (PDE5i) improve NO levels. The aim of the study was to investigate whether long-term, chronic treatment with the PDE5i vardenafil improves systemic endothelial function in diabetic men.DesignA prospective, investigator-initiated, randomized, placebo-controlled, double-blind, clinical trial was conducted.MethodsIn total, 54 male patients affected by T2DM, diagnosed within the last 5 years, and erectile dysfunction were enrolled, regardless of testosterone levels. In all, 26 and 28 patients were assigned to verum and placebo groups respectively. The study consisted of an enrollment phase, a treatment phase (24 weeks) (vardenafil/placebo 10 mg twice in a day) and a follow-up phase (24 weeks). Parameters evaluated were as follows: International Index of Erectile Function 15 (IIEF-15), flow-mediated dilation (FMD), serum interleukin 6 (IL6), endothelin 1 (ET-1), gonadotropins and testosterone (measured by liquid chromatography/tandem mass spectrometry).ResultsIIEF-15 erectile function improved during the treatment (P<0.001). At the end of the treatment both FMD (P=0.040) and IL6 (P=0.019) significantly improved. FMD correlated with serum testosterone levels (R2=0.299;P<0.001). Testosterone increased significantly under vardenafil treatment and returned in the eugonadal range only in hypogonadal men (n=13), without changes in gonadotropins. Chronic vardenafil treatment did not result in relevant side effects.ConclusionThis is the first double-blind, placebo-controlled clinical trial designed to evaluate the effects of chronic treatment of vardenafil on endothelial health-related parameters and sexual hormones in patients affected by a chronic disease. Chronically administered vardenafil is effective and improves endothelial parameters in T2DM patient. Moreover, chronic vardenafil therapy improves hypogonadism in diabetic, hypogonadal men.

scholarly journals High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study

Diabetologia ◽  
2008 ◽  
Vol 52 (2) ◽  
pp. 208-212 ◽  
Author(s):  
N. Rabbani ◽  
S. S. Alam ◽  
S. Riaz ◽  
J. R. Larkin ◽  
M. W. Akhtar ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Pilot Study ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Thiamine Therapy
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