The aim of this study was to evaluate the efficacy and safety of an anti-hypercholesterolemic agent containing
,
and monacolin K and KA in a sample of Caucasian patients at low cardiovascular risk ...according to Framingham score. The primary outcome was to evaluate the effects of this nutraceutical combination on lipid profile; the secondary outcome was to evaluate the effect on some inflammatory markers, in particular high sensitivity C-reactive protein and tumor necrosis factor-α interleukin-6. One hundred and forty-three patients were randomized to placebo or Berberol
K, once a day, during the dinner, for 3 months, in a randomized, double-blind, placebo-controlled trial. We recorded a significant reduction of fasting plasma glucose with Berberol
K compared to placebo (-12.2%,
< 0.05). Moreover, we recorded an increase of fasting plasma insulin with Berberol
K both compared to baseline and to placebo (+9.9%,
< 0.05). Accordingly, the homeostasis model assessment (HOMA) index obtained after treatment with Berberol
K was lower than the one in the placebo group (-2.8%,
< 0.05). No variations of lipid profile were observed with placebo, while there was a significant decrease of total cholesterol (-20.5%,
< 0.05), triglycerides (-17.7%,
< 0.05), and low density lipoprotein (LDL) cholestero (-27.8%,
< 0.05) with Berberol
K, compared to placebo. There was a decrease of high sensitivity C-reactive protein (-30.8%,
< 0.05), and interleukin-6 (-25.0%,
< 0.05), with Berberol
K compared to placebo. In conclusion, combining different hypocholesterolemic nutraceutical agents such as
,
and monacolin K and KA could be effective and safe to obtain a reduction of lipid profile and an improvement of inflammatory parameters.
Compared to higher income couples, those with low incomes experience a host of challenges and disparities in their intimate relationships, including lower levels of relationship satisfaction, higher ...rates of breakup of cohabiting relationships, and higher rates of divorce. In recognition of these disparities, a number of interventions targeting couples with low incomes have been developed. These interventions historically focused primarily on improving relationship skills through relationship education, but in recent years a new approach that integrates economic-focused interventions alongside relationship education has emerged. This integrated approach is intended to better address the challenges facing couples with low incomes, but the theory-driven, top-down approach to intervention development leaves open the question of whether couples with low incomes are interested in participating in a program that combines these two disparate components. The current study draws from a large randomized controlled trial of one such program (N = 879 couples) to provide descriptive information about the recruitment and retention of couples with low incomes in a study of relationship education with integrated economic services. Results indicate that it is possible to recruit a large, linguistically, and racially diverse sample of couples living with low income to participate in an integrated intervention, but the uptake of relationship-focused services was higher than the uptake of economic-focused services. Additionally, attrition over a 1-year follow-up data collection period was low but required labor-intensive efforts to reach participants for the survey. We highlight successful strategies for the recruitment and retention of diverse couples and discuss implications for future intervention efforts.
To evaluate if a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate (Reglicem
), can ameliorate glycemic status in patients with dysglycemia.
We enrolled 148 ...patients with impaired fasting plasma glucose or impaired glucose tolerance, not taking any hypoglycemic compounds. Patients were randomized to take nutraceutical or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Both nutraceutical and placebo were self-administered once a day, 1 tablet during the breakfast.
A reduction of fasting and post-prandial plasma glucose was observed with the nutraceutical combination (p < 0.05 vs baseline and p < 0.05 vs placebo, respectively). Furthermore, a decrease of glycated hemoglobin, and fasting plasma insulin was observed with the nutraceutical combination (p < 0.05 vs baseline and p < 0.05 vs placebo, respectively). Then, there was a reduction of homeostasis model assessment index with the nutraceutical combination (p < 0.05 vs baseline and p < 0.05 vs placebo). M value was higher (p < 0.05 vs baseline and p < 0.05 vs placebo) in the nutraceutical combination group at the end of the treatment. We observed a reduction of total cholesterol (TC) (p < 0.05 vs baseline) and triglycerides (Tg) (p < 0.05 vs baseline and p < 0.05 vs placebo) with the nutraceutical combination, respectively. Finally, high sensitivity C-reactive protein was reduced after 3 months with nutraceutical combination therapy (p < 0.05 vs baseline and p < 0.05 vs placebo, respectively).
A nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate can be helpful in improving glyco-metabolic compensation, TC and Tg value, and in reducing inflammatory status in patients with dysglycemia.
Psoriasis is an immune-mediated dermatosis with cardio-metabolic comorbidities. The aim of this study was to assess insulin-resistance, lipid abnormalities, and cardiovascular risk biomarkers in ...psoriatic patients with or without type 2 diabetes mellitus (T2DM).
We enrolled 425 patients: 86 psoriatics, 69 psoriatics with T2DM, 120 T2DM patients, and 150 healthy subjects. We measured the Psoriasis Area and Severity Index (PASI), body mass index (BMI), insulin-resistance parameters glycosylated hemoglobin (HbA
), fasting plasma glucose (FPG), fasting plasma insulin (FPI), and with homeostasis model assessment index (HOMA index), lipidic panel, plasminogen activator inhibitor-1 (PAI-1), homocysteine, soluble adhesion molecules, matrix metalloproteinase, and adipocytokines.
FPG, HbA
, and HOMA-IR were higher in diabetics with psoriasis (
< 0.0001) than in psoriatics. FPI levels were higher in diabetics with psoriasis than in diabetics and psoriatics (
< 0.0001), and higher in psoriatics than controls (
< 0.0001). Psoriatics and diabetics with psoriasis showed higher triglyceride and LDL-C levels (
< 0.0001) than diabetics. Homocysteine was higher in psoriatics and diabetics with psoriasis (
< 0.0001) than in diabetics. PAI-1 was higher in diabetics with psoriasis than diabetics (
< 0.01). sICAM-1 and sVCAM-1 were higher in diabetics with psoriasis than diabetics (
< 0.001 and
< 0.01) and psoriatics (
< 0.001 and
< 0.0001). Visfatin and resistin were lower in psoriatics (
< 0.0001) and in diabetics with psoriasis (
< 0.001 and
< 0.0001, respectively) than diabetics.
A limitation of this study is that there is a significant difference in mean age between controls and other study groups: the lack of matching between case and control groups may interfere with the external validity of the study findings. Despite this, the study highlights a pathogenetic link between psoriasis, considered a pre-diabetic condition, and diabetes. Insulin-resistance seems to be the keystone of psoriasis comorbidities. Psoriasis reinforces diabetes, causing a greater cardiometabolic risk.
Background: Hepatic fibrosis is characterized by a progressive accumulation of fibrillar extracellular matrix (ECM) proteins including collagen, which occurs in most types of chronic liver diseases. ...Transforming growth factor‐β (TGF‐β)/Smad3 signalling plays a central role in tissue fibrogenesis, acting as a potent stimulus of ECM accumulation.
Aim: To evaluate the potential protective role of Smad3 deficiency in the pathogenesis of liver fibrosis induced by dimethylnitrosamine (DMN) in Smad3 null mice.
Methods: Chronic hepatitis‐associated fibrosis was induced in 13 Smad3 null and 13 wild‐type (WT) mice by intraperitoneal DMN administration (10 μg/g body weight/day) for three consecutive days per week for 6 weeks. The liver was excised for macroscopic examination and histological, morphometric and immunohistochemical (IHC) analyses. For IHC, α‐smooth muscle actin (α‐SMA), collagen types I–III, TGF‐β1, connective tissue growth factor (CTGF), Smad3, Smad7 and CD3 antibodies were used.
Results: At macroscopic examination, the liver of DMN‐treated Smad3 WT appeared harder with a dark brown colouring and necrotic areas compared with that from null mice. Histological and morphometric evaluation revealed a significantly higher degree of hepatic fibrosis and accumulation of connective tissue in the Smad3 WT compared with null mice. IHC evaluation showed a marked increase in α‐SMA, CTGF, collagen I‐III, TGF‐β and Smad3 staining in the liver of Smad3 WT compared with that in null mice, whereas Smad7 was increased only in null mice.
Conclusions: The results indicate that Smad3 loss confers resistance to the development of DMN‐induced hepatic fibrosis. The reduced fibrotic response appears to be due to a reduction of fibrogenic myofibroblast activation and ECM production and accumulation. Smad3 could be a novel target for potential treatment of fibrosis complicating chronic hepatitis.
Abstract The aim of the study was to compare the effects of the addition of sitagliptin or metformin to pioglitazone monotherapy in poorly controlled type 2 diabetes mellitus patients on body weight, ...glycemic control, β -cell function, insulin resistance, and inflammatory state parameters. One hundred fifty-one patients with uncontrolled type 2 diabetes mellitus (glycated hemoglobin HbA1c >7.5%) in therapy with pioglitazone 30 mg/d were enrolled in this study. We randomized patients to take pioglitazone 30 mg plus sitagliptin 100 mg once a day, or pioglitazone 15 mg plus metformin 850 mg twice a day. We evaluated at baseline and after 3, 6, 9, and 12 months these parameters: body weight, body mass index, HbA1c , fasting plasma glucose (FPG), postprandial plasma glucose (PPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), homeostasis model assessment β -cell function index, fasting plasma proinsulin (Pr), Pr/FPI ratio, adiponectin, resistin (R), tumor necrosis factor- α (TNF- α ), and high-sensitivity C-reactive protein. A decrease of body weight and body mass index was observed with metformin, but not with sitagliptin, at the end of the study. We observed a comparable significant decrease of HbA1c , FPG, and PPG and a significant increase of homeostasis model assessment β -cell function index compared with baseline in both groups without any significant differences between the 2 groups. Fasting plasma insulin, fasting plasma Pr, Pr/FPI ratio, and HOMA-IR values were decreased in both groups even if the values obtained with metformin were significantly lower than the values obtained with sitagliptin. There were no significant variations of ADN, R, or TNF- α with sitagliptin, whereas a significant increase of ADN and a significant decrease of R and TNF- α values were recorded with metformin. A significant decrease of high-sensitivity C-reactive protein value was obtained in both groups without any significant differences between the 2 groups. There was a significant correlation between HOMA-IR decrease and ADN increase, and between HOMA-IR decrease and R and TNF- α decrease in pioglitazone plus metformin group after the treatment. The addition of both sitagliptin or metformin to pioglitazone gave an improvement of HbA1c , FPG, and PPG; but metformin led also to a decrease of body weight and to a faster and better improvement of insulin resistance and inflammatory state parameters, even if sitagliptin produced a better protection of β -cell function.
Objective The effects of dipeptidyl peptidase-4 (DPP-4) inhibition on adipose tissue inflammation remain obscure. The aim of this study was to evaluate the effects of the addition of sitagliptin on ...the β-cell function and various inflammatory biomarkers in type 2 diabetic patients. Methods After a run-in period of taking metformin, 178 diabetic patients with poor glycemic control were randomized to take sitagliptin at a dose of 100 mg once a day or a placebo in addition to metformin for 12 months. We evaluated the following parameters at three, six, nine and twelve months: body mass index (BMI), glycemic control, the homeostasis model assessment insulin resistance index (HOMA-IR), the homeostasis model assessment β-cell function index (HOMA-β), the proinsulin/fasting plasma insulin ratio (Pr/FPI ratio) and the levels of fasting plasma insulin (FPI), fasting plasma proinsulin (FPPr), C-peptide, glucagon, resistin, vaspin, omentin-1 and tumor necrosis factor-α (TNF-α). Before and twelve months after the addition of sitagliptin, the patients underwent combined euglycemic hyperinsulinemic and hyperglycemic clamping with subsequent arginine stimulation to assess insulin sensitivity and secretion. Results Treatment with sitagliptin + metformin was more effective than placebo + metformin in improving glycemic control, the HOMA-IR and the glucagon level and increasing the HOMA-β and all β-cell measurements after combined euglycemic hyperinsulinemic and hyperglycemic clamping with subsequent arginine stimulation. Regarding inflammatory biomarkers, sitagliptin + metformin more effectively reduced the levels of resistin, vaspin and omentin-1 than placebo + metformin. Conclusion When treatment with metformin alone is not adequate for obtaining glycemic control, the addition of sitagliptin can be considered due to its actions in preserving the β-cell function and reducing the levels of biomarkers of inflammation.
The aim of this study was to evaluate the effects of acarbose on inflammatory biomarkers and insulin resistance in diabetic patients before and after a standardized oral fat load (OFL). Ninety six ...patients were assigned to take acarbose 50mg three times a day and 92 to take placebo; after the first month acarbose was titrated to 100mg three times a day. We evaluated the following parameters at the baseline, and after 1, 2 and 7months: body mass index (BMI), glycemic control, fasting plasma insulin, post-prandial plasma insulin, homeostasis model assessment insulin resistance index (HOMA-IR), blood pressure, lipid profile, soluble intercellular adhesion molecule-1 (sICAM-1), interleukin-6 (IL-6), high-sensitivity C reactive protein (Hs-CRP), soluble vascular cell adhesion molecule-1 (sVCAM-1), and soluble E-selectin (sE-selectin). Furthermore, at the baseline and at the end of the study all patients underwent OFL, and an euglycemic hyperinsulinemic clamp to evaluate M value and total glucose requirement. Acarbose was better than placebo in improving glycemic and lipid profile, and HOMA-IR. Furthermore, acarbose gave a decrease of fasting plasma insulin, post-prandial insulin, s-ICAM-1, sVCAM-1, IL-6, and Hs-CRP, not observed with placebo, even if no significant differences between the two groups were observed. During the second OFL performed after the therapy with acarbose, we observed a significant decrease of all inflammatory parameters' peaks compared to the OFL administered at baseline. Acarbose was more effective than acarbose in reducing the post-OFL peaks of the various parameters included the inflammatory markers, after 7months of therapy.
Sufficiently powered studies to investigate the CKD prevalence are few and do not cover southern Europe.
For the INCIPE study, 6200 Caucasian patients ≥40 years old were randomly selected in ...northeastern Italy in 2006. Laboratory determinations were centralized. The albumin to creatinine ratio in urine and estimated GFR from calibrated creatinine (SCr) were determined. A comparison with 2001 through 2006 NHANES surveys was performed.
Prevalence of CKD was 13.2% in northeastern (NE) Italy (age and gender standardized to the U.S. 2007 Caucasian population). Prevalence of CKD in U.S. Caucasians is higher (20.3%), the major difference being in CKD 3. Risk factors for CKD are more prevalent in the United States than in Italy. With use of CKD 3a and 3b stages, CKD prevalence decreased in NE Italy (8.5%) and in the United States (12.8%).
The prevalence of CKD is high in NE Italy, but lower than that in the United States. A large part of the difference in CKD prevalence in NE Italy versus that in the United States is due to the different prevalence of CKD 3. The higher prevalence of a number of renal risk factors in persons from the United States explains in part the different dimensions of the CKD problem in the two populations.
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