Effects of a Mediterranean-style diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes: a randomized trial.

BACKGROUND: Low-carbohydrate and low-fat calorie-restricted diets are recommended for weight loss in overweight and obese people with type 2 diabetes. OBJECTIVE: To compare the effects of a low-carbohydrate Mediterranean-style or a low-fat diet on the need for antihyperglycemic drug therapy in patients with newly diagnosed type 2 diabetes. DESIGN: Single-center, randomized trial. Randomization was computer-generated and unstratified. Allocation was concealed in sealed study folders held in a central, secure location until participants gave informed consent. Participants and investigators were aware of treatment assignment, and assessors of the primary outcome were blinded. SETTING: Teaching hospital in Naples, Italy. PATIENTS: 215 overweight people with newly diagnosed type 2 diabetes who were never treated with antihyperglycemic drugs and had hemoglobin A(1c) (HbA(1c)) levels less than 11%. INTERVENTION: Mediterranean-style diet (<50% of daily calories from carbohydrates) (n = 108) or a low-fat diet (<30% of daily calories from fat) (n = 107). MEASUREMENTS: Start of antihyperglycemic drug therapy, defined by protocol as indicated for follow-up HbA(1c) level greater than 7% (primary outcome), and changes in weight, glycemic control, and coronary risk factors (secondary outcomes). RESULTS: After 4 years, 44% of patients in the Mediterranean-style diet group and 70% in the low-fat diet group required treatment (absolute difference, -26.0 percentage points [95% CI, -31.1 to -20.1 percentage points]; hazard ratio, 0.63 [CI, 0.51 to 0.86]; hazard ratio adjusted for weight change, 0.70 [CI, 0.59 to 0.90]; P < 0.001). Participants assigned to the Mediterranean-style diet lost more weight and experienced greater improvements in some glycemic control and coronary risk measures than did those assigned to the low-fat diet. LIMITATIONS: Investigators responsible for initiating drug therapy were not blinded to treatment assignment. Dietary intake was self-reported. CONCLUSION: Compared with a low-fat diet, a low-carbohydrate, Mediterranean-style diet led to more favorable changes in glycemic control and coronary risk factors and delayed the need for antihyperglycemic drug therapy in overweight patients with newly diagnosed type 2 diabetes. PRIMARY FUNDING SOURCE: Second University of Naples.

Hyperlipidemia and sexual function in premenopausal women.

INTRODUCTION: No reported studies exist assessing the relationship between sexual function and hyperlipidemia in women. AIM: In this study, we assessed the domains of sexual function in a representative sample of sexually active premenopausal women with hyperlipidemia, but without cardiovascular disease, as compared with an age-matched female population without hyperlipidemia. METHODS: To be enrolled in the study, women had to meet at least one of the following criteria for the diagnosis of hyperlipidemia: low-density lipoprotein (LDL) cholesterol levels >160 mg/dL; high-density lipoprotein (HDL) cholesterol levels <50 mg/dL; or triglyceride levels >150 mg/dL. Lipid parameters were assessed and verified on blood taken at least twice in the hospital during the screening phase. Four hundred forty-one premenopausal women with hyperlipidemia were compared with 115 age-matched premenopausal women without hyperlipidemia. MAIN OUTCOME MEASURES: We used the Female Sexual Function Index (FSFI) for assessing the key dimensions of female sexual function. RESULTS: The two groups were well matched for age and smoking prevalence. Compared with women of the control group, women with hyperlipidemia had reduced mean global FSFI score (22.8 +/- 6.8 vs. 29.4 +/- 4.9, P < 0.001). Individual analysis of the different domains showed that women with hyperlipidemia reported significantly lower arousal, orgasm, lubrication, and satisfaction scores than control women. Based on the total FSFI score, 51% of women with hyperlipidemia had scores of 26 or less, indicating sexual dysfunction, as compared with 21% of women without hyperlipidemia (P < 0.001). Based on a more conservative analysis including women under the lower quartile of the distribution of FSFI score, 32% of women with hyperlipidemia had scores of 23 or less, as compared with 9% of women without hyperlipidemia (P < 0.001). Multiple regression analysis identified age, body mass index, HDL-cholesterol and triglycerides as independent predictors of FSFI score. CONCLUSIONS: Women with hyperlipidemia have significantly lower FSFI-domain scores as compared with age-matched women without hyperlipidemia. HDL cholesterol and triglyceride levels were independently associated with the FSFI score.

Post-meal glucose peaks at home associate with carotid intima-media thickness in type 2 diabetes.

CONTEXT: Two-hour postprandial hyperglycemia is related to chronic complications of diabetes and is currently used in the international guidelines to drive the therapy. OBJECTIVE: Our objective was to assess the size and timing of post-meal glucose peaks in the everyday life of type 2 diabetic patients and the relationship with carotid atherosclerosis. DESIGN, SETTING, AND PATIENTS: This was an observational study performed in 644 outpatients with type 2 diabetes attending diabetes clinics located in the area of the Campania County, South Italy, who provided complete home blood glucose profiles and centralized carotid intima-media thickness (CIMT) assessment. The study was conducted from 2001-2005. MAIN OUTCOME MEASURES: Incremental glucose peak (IGP) was the maximal incremental increase in blood glucose obtained at any point after the meal. CIMT was assessed by carotid sonography. RESULTS: The level of glycosylated hemoglobin and CIMT progressively increased across quintiles of IGP (P for trend = 0.01 for both). In univariate analysis, all examined glycemic parameters were significantly correlated with CIMT. IGP (r = 0.40; P = 0.006) showed the strongest correlation with CIMT, which remained significant in multiple linear regression analysis (R(2) = 0.26; P = 0.01). IGP was associated with a significant increase of CIMT in tertiles of glycosylated hemoglobin. IGP occurred within 1 h from the start of the meal in 95% of the entire diabetic population. CONCLUSION: IGPs are frequent in the everyday life of patients with type 2 diabetes, occur for most (95%) within 1 h after meal, timing of IGPs is not influenced by treatment (diet or drugs), and IGPs correlate with CIMT.

Effect of a single high-fat meal on endothelial function in patients with the metabolic syndrome: role of tumor necrosis factor-alpha.

BACKGROUND AND AIMS: A single high-fat meal may induce endothelial activation and dysfunction in both normal subjects and in patients with type 2 diabetes. The aim of this study was to assess the effect of a high-fat meal on endothelial function in patients with the metabolic syndrome. METHODS AND RESULTS: Twenty-five patients with the metabolic syndrome (ATP III criteria) were matched for sex, age and body mass index with 25 subjects without the metabolic syndrome. All subjects ate under supervision a high fat meal (760 calories) with 59% energy from fat, 12% energy from protein and 29% energy from carbohydrates. Compared with the control group, subjects with the metabolic syndrome had reduced endothelial function, as assessed with the l-arginine test, and higher circulating levels of TNF-alpha. Following the high-fat meal, both triglyceride and TNF-alpha levels increased more in subjects with the metabolic syndrome than in subjects without, while endothelial function decreased more in subjects with the metabolic syndrome. There was a significant relation between increases in TNF-alpha levels and decreases in endothelial function score in subjects with the metabolic syndrome (r=-0.39, P=0.03). CONCLUSION: TNF-alpha levels are increased in subjects with the metabolic syndrome; moreover, a high-fat meal produces further increase in its levels associated with endothelial dysfunction.

Effect of rosiglitazone on endothelial function and inflammatory markers in patients with the metabolic syndrome.

OBJECTIVE: The aim of this study was to assess the effect of rosiglitazone on endothelial function and inflammatory markers in patients with the metabolic syndrome. RESEARCH DESIGN AND METHODS: This was a randomized, double-blind, controlled clinical trial. One hundred subjects (54 men and 46 women) with the metabolic syndrome, as defined by the Adult Treatment Panel III, were followed for 12 months after random assignment to rosiglitazone (4 mg/day) or placebo. Primary end points were flow-mediated dilation and high-sensitivity C-reactive protein (hs-CRP) levels; secondary end points were lipid and glucose parameters, homeostasis model assessment (HOMA) of insulin sensitivity, endothelial function score, and circulating levels of interleukin (IL)-6, IL-18, and adiponectin. RESULTS: Compared with 60 control subjects matched for age and sex, patients with the metabolic syndrome had decreased endothelial function, raised concentrations of inflammatory markers, and reduced insulin sensitivity. After 12 months, subjects with the metabolic syndrome receiving rosiglitazone showed improved flow-mediated vasodilation (4.2%, P < 0.001) and reduced hs-CRP levels (-0.7 mg/dl, P = 0.04), compared with the placebo group. Moreover, HOMA (-0.8, P = 0.01) and serum concentrations of IL-6 (-0.5 pg/ml, P = 0.045) and IL-18 (-31 pg/ml, P = 0.036) were significantly reduced in subjects receiving rosiglitazone, whereas adiponectin levels showed a significant increment (2.3 microg/ml, P = 0.02). High-density lipoprotein-cholesterol levels increased more and triglyceride levels decreased more in the rosiglitazone group compared with the placebo group. At 1 year of follow-up, 30 subjects receiving rosiglitazone still had features of the metabolic syndrome, compared with 45 subjects receiving placebo (P < 0.001). CONCLUSIONS: Rosiglitazone might be effective in reducing the prevalence of the metabolic syndrome.