Menstrual cycle length, serum lipids and lipoproteins in a cohort of Italian Mediterranean women: findings from Progetto ATENA.

BACKGROUND AND AIMS: Clinical studies suggest that menstrual irregularities are associated with metabolic and hormonal abnormalities, insulin resistance and a hyperestrogenic/hyperandrogenic imbalance, that may influence the risk of cardiovascular disease. METHODS AND RESULTS: The association of these abnormalities with the metabolic syndrome suggests that information on lipid patterns at different menstrual cycle length may be of interest in identifying women at higher cardiovascular risk. The association of lipid patterns with menstrual cycle length was evaluated in a cohort of 5062 women participating in the Progetto ATENA Study. Questions were administered to the participants about their cycle lengths at different periods of time over their reproductive life. The period between 20 and 50 years was investigated: normal cycle length was defined as short (30 days). Perimenopausal women were excluded and variables adjusted for age, BMI and menopausal status. In 4434 participants serum triglycerides were found to increase with an increased number of days in the menstrual cycle: 106 mg/dl in the short cycle pattern (21-26 days); 113 mg/dl in the medium cycle pattern (27-29 days); and 116 mg/dl in the long cycle pattern (30-31 days), whereas total and LDL cholesterol were found to be higher and HDL was lower in women with longer cycles, but the difference was not statistically significant. The results were very similar when the same adjusted analysis was restricted to a subgroup of 3823 women with a stable cycle length over the fourth and the fifth decade of life. CONCLUSIONS: These results suggest that cycle length may be a marker of higher cardiovascular risk due to associated metabolic and hormonal patterns.

Effectiveness and safety of insulin glargine in the therapy of complicated or secondary diabetes: clinical audit.

We wanted to assess the effectiveness and safety of glargine in the treatment of patients with type 2 diabetes mellitus in secondary failure and/or with severe comorbidities ("T2DM group"), and patients with secondary diabetes after corticosteroid and/or anticancer treatment ("secondary DM group"). We reviewed the records of patients on glargine from 1 August 2004 to 30 July 2005. The after-minus-before change in HbA1c was the main outcome measure. At baseline, the 18 "T2DM" patients had a mean (+/-SD) age of 66.7+/-9.5 years and a diabetes duration of 13.6+/-10.3 years; 52.9% were male. Their fasting plasma glucose (FPG) decreased from 228.6+/-76.6 to 134.6+/-37.5, two-hour post-prandial glycaemia (2hPPG) from 268.2+/-10.4 to 140.6+/-30.8 and HbA1c from 10.4+/-2.3 to 7.9+/-1.6%. Mean daily insulin dosage was 12.0+/-4.8 UI for glargine alone and 37.4+/-22.6 UI for basal-bolus scheme. The daily cost was Euro 0.75 (range Euro 0.31-1.15). The 24 "secondary DM" patients had a mean age of 67.0+/-11.0 years and a diabetes duration of 3.7+/-6.5 years; 54.2% were male and 91.7% had a metastatic cancer. Their FPG decreased from 222.3+/-108.6 to 121.5+/-28.7 mg/dl, 2hPPG from 259.4+/-108.6 to 133.0+/-35.0 mg/dl and HbA1c from 10.1+/-2.5 to 7.6+/-1.3%. Mean daily insulin dosage was 12.5+/-6.1 UI for glargine alone and 27.2+/-9.1 UI for basal-bolus scheme. Mean daily cost was Euro 0.70 (range Euro 0.31-1.38). One (4.2%) cancer patient withdrew from glargine because of nausea. Nine (37.5%) cancer patients had an increase in appetite after glargine therapy, including 3 end-of-life patients. No severe hypoglycaemia occurred. Insulin glargine was safe and effective in improving glycaemic control both in severe "T2DM" and in "secondary DM" patients.

How to start or change a daily insulin regimen without a specialist in diabetes. Effectiveness and RAND assessment of practical schemes for in-hospital or hospital-based home care services use.

When the diabetic patient is hospitalised or assisted by a hospital-based home care service, as a rule he/she is not cared for by a diabetologist all day long. The aim of the present work was to perform a RAND assessment of practical schemes to start or change a daily insulin regimen without a diabetologist. We created an expert panel of seven internists and two diabetologists. They judge the appropriateness of each practical scheme using the RAND method. We produced 21 clinical scenarios divided into two groups. The first group of 9 clinical scenarios-i.e., for diabetic patients who 'eat/not-always-eat' and are 'normal-weight/obese/underweight' or with 'renal failure' or 'defedated/end-of-life' or 'vomiting' or on 'parenteral nutrition'-useful for starting a daily insulin regimen without a diabetologist had a median RAND score of 8 (range 7-9). The second one-formed by 12 clinical scenarios useful to change the daily insulin dosage without a diabetologist based on low or high capillary glucose level monitoring-had a median RAND score of 9 (range 7-9). There was a high level of agreement between panellists in judging 'appropriate' the practical schemes to start or change a daily insulin regimen without a diabetologist.

Effectiveness and safety of carotid endarterectomy under remifentanil.

AIM: The aim of this study was to evaluate the effectiveness and safety of carotid endarterectomy (CEA) with conscious sedation under remifentanil (Remifentanil anesthesia - RA) vs conventional loco-regional anesthesia (Conventional-LRA) in the current practice of a vascular surgery unit. METHODS: We introduced the ''Remifentanil-RA'' in our practice according to a two-step protocol. In the first step we performed a pilot prospective study to assess the procedure's safety and reproducibility in our setting on 60 consecutive patients with symptomatic and/or high-grade (>70%) internal carotid artery stenosis and alternately assigning them either to ''Remifentanil-RA'' or ''Conventional-LRA'' CEA. In the second step we analysed our routine operative records as to effectiveness and safety on 533 patients who consecutively underwent ''Remifentanil-RA'' CEA. We compared them with 533 age- and sex-matched historical controls who underwent ''Conventional-LRA'' CEA. RESULTS: The patients' mean age was 71.2+/-6.8 vs 71.8+/-6.1 (''Remifentanil-RA'' vs ''Conventional-LRA''). About 73% of them were male and 56% had a symptomatic carotid stenosis. Neither the pilot study nor second step comparison showed differences in outcome measures. We found only higher peri-operative nausea/ vomit (3.6% vs 0.4% ''Remifentanil-RA'' vs ''Conventional-LRA'', P<0.0002) and fewer re-operations for post-operative hematomas (3% vs 5.4% respectively, P=0.048). CONCLUSIONS: We found that ''Remifentanil-RA'' CEA was safe, effective and satisfactory. Nevertheless, with the potential problems of intubation and those already found with side effects, a randomized control trial (RCT) is needed in order to prove that this method is superior to ''Conventional-LRA'' CEA.

Characteristics of Type 2 diabetic patients cared for by general practitioners either with medical nutrition therapy alone or with hypoglycaemic drugs.

The essential role of medical nutrition therapy (MNT) for people with diabetes is widely recognised, and its exclusive use is recommended in mild diabetes according to a stepwise therapeutic approach. We describe the characteristics of MNT-treated Type 2 diabetic patients (vs drugs) cared for by general practitioners (GPs) in order to check that appropriate differences did exist between the two groups, by auditing the data from our local shared-care program for diabetes. We had 16,000 diabetic patients (out of 630,000 inhabitants); 6,800 of them (42.5%) cared for by GPs. Thirty-one percent (2,079 out of 6,800 patients cared for by GPs) were treated with MNT and 69% with drugs. The MNT-treated patients (vs drugs) were younger (66.1 +/- 10.7 vs 67.7 +/- 11.0 yr, p<0.01), had shorter disease duration (8.2 +/- 6.6 vs 11.2 +/- 7.6 yr, p<0.01), lower HbA1c (7.0 +/- 1.1 vs 7.8 +/- 1.6%, p<0.01) and body mass index (BMI) (28.6 +/- 4.6 vs 29.0 +/- 4.9 kg/m2, p<0.01). They had less prevalence of high blood triglycerides (25.4% vs 29.0%, p<0.01). MNT-treated patients had less micro-albuminuria (5.3% vs 8.8%, p<0.01); less retinopathy both non-proliferant (6.5% vs 11.1%, p<0.01), and pre-proliferant (6.8% vs 12.7%, p<0.01), and proliferant (7.0% vs 12.9%, p<0.01); less peripheral neuropathy (3.9% vs 8.3%, p<0.01); and diabetic foot (1.0% vs 2.0%, p<0.01). They had less chronic heart failure (2.7% vs 4.6%, p<0.01), and claudicatio intermittens (3.3% vs 5.3%, p<0.01). In conclusion, the Type 2 diabetic patients cared for by GPs using MNT appropriately had a less severe form of diabetes.

Audit of a shared-care program for persons with diabetes: baseline and 3 annual follow-ups.

In Italy, data on shared-care programs for diabetes are lacking. We described the characteristics of type 2 diabetic population assisted in general practice and evaluated 3 years of follow-up outcomes and performance indicators in a shared-care program in Modena, Italy (1998-2001); only well-controlled diabetic patients were considered. Forty-nine percent of territorial GPs adhered to the project (257 out of 521) and 77% of them sent 6409 paired baseline and follow-up datasheets. Altogether, 97.8% patients had type 2 diabetes, mean age 68.6+/-11.7 years, disease duration 9.6+/-7.5 years, BMI 28.6+/-4.8 kg/m2, HbA(1c) 7.6%+/-1.6%, 16.1% of them were disabled. Among the non-disabled patients, 23.6% had optimal glycemic control (HbA(1c) < or =6.5%); at baseline the prevalence of micro- and macrovascular diabetic complications was: 8.2% microalbuminuria and 2.4% macroalbuminuria plus nephropathy, 11.0% nonproliferative and 3.0% preproliferative retinopathy, 7.0% neuropathy, 1.8% diabetic foot; 8.5% angina, 6.9% TIA or stroke, 6.3% infarction, 5.2% intermittent claudication, 4.1% heart failure. Among the disabled patients 27.9% had optimal glycemic control, but they had more diabetic complications. The performance indicators significantly improved over the 3-year study period: glycemic control indicators increased from 66%-75% to 83%-90% and micro- and macrovascular indicators from 59%-65% to 75%-81%. The outcome indicators also improved: mean HbA(1c) value changed from 7.6%+/-1.6% to 7.3%+/-1.3% and the percentage of people with HbA(1c)< or =6.5% significantly improved over time. Similar trends were observed in both disabled and non-disabled diabetic patients.

A diagnosis of left ventricular hypertrophy on ECG is associated with a high cardiovascular risk: findings from a 40- to 69-year-old cohort in general practice.

OBJECTIVE: Left ventricular hypertrophy (LVH) is an independent cardiovascular (CV) risk factor in both sexes. We studied if a diagnosis of LVH on electrocardiogram (ECG) was associated with a 'high CV risk condition' among 40- to 69-year-old individuals cared for by GPs. METHODS: We studied 4250 individuals, 5.4% of whom had LVH. Cross-sectional frequencies, and age- and gender-adjusted statistical differences have been calculated. RESULTS: All the study variables were significantly worse for 'LVH' than 'non-LVH' individuals (except smoking). The 'LVH' had both a mean '5-year CV risk' significantly greater than 'non-LVH' individuals (27.0% versus 8.6%), and a significantly higher prevalence of a '5-year CV risk >15%' (89% versus 15%). CONCLUSIONS: A diagnosis of LVH on ECG among the adult individuals of an opportunistic cohort from general practice was associated with a 6-fold greater prevalence of a 'high CV risk condition'.

GPs' satisfaction with the doctor-patient encounter: findings from a community-based survey.

OBJECTIVE: The aim of this study was to explore the characteristics of the doctor-patient relationship from the GP's point of view. METHODS: We performed a cross-sectional 1-day study in family practice. Thirty-three GPs volunteered to fill in a questionnaire at the end of each of 20 consecutive consultations on an index day. Six hundred and sixty-one patients (out of 665) participated in the study. Descriptive frequencies of GPs' judgements about personal experiences during the consultations, and predictors of GP's global satisfaction score on patient encounters were analysed. RESULTS: The mean age of the 33 GPs was 44.7 +/- 3.6 years. Professional skills (62% of the GPs had no doubts on diagnosis, therapy or prognosis) and the quality of the human/interpersonal interaction were major determinants of GPs' satisfaction in the patient-doctor relationship. Doctors felt professionally esteemed by 90% of their patients, and the median value of their global satisfaction score (matching the expectations from an 'ideal patient' to that experienced when meeting the real one) was very high (median 8, range 1-10). Nevertheless, GPs did not know if they were satisfied with the actual encounter with the patient in about one-third of the consultations. CONCLUSIONS: Professional skills and quality of the human/interpersonal interactions are major determinants of GPs' satisfaction in their professional activities.

Changes in long-term glycemic control and performance indicators in a cohort of type 2 diabetic patients cared for by general practitioners: findings from the "Modena Diabetes Project".

BACKGROUND AND AIM: General practitioners (GPs) are being increasingly asked to play a key role in the shared care of people with diabetes mellitus, but data concerning the effects of this in Italy are still scarce. We therefore evaluated the 4-year follow-up changes in outcomes and performance indicators in type 2 diabetic patients cared for by GPs in the framework of the "Modena Diabetes Project". METHODS AND RESULTS: Seventy-four percent of the local GPs participating in the project (387 out of 521) sent 5260 paired baseline and follow-up datasheets. The baseline characteristics of the type 2 diabetic patients (49.6% male) were a mean age of 67.3+/-11.2 years, a mean disease duration of 10.9+/-7.4 years, a mean BMI of 28.7+/-4.8 kg/m2, and a mean HbA1c level 7.56+/-1.52%. After four years follow-up, the individual before/after match-paired outcomes revealed an improvement in glycemic control: HbA1c levels significantly decreased to 7.39+/-1.31%, and the percentage of patients with HbA1c level of <6.5% significantly increased from 15.7% to 22.1%. There was also a significant decrease in body weight (from 78.3+/-14.8 to 77.6+/-14.6 kg) and BMI (from 28.8+/-4.8 to 28.5+/-4.9 kg/m2). The time trends of glycemic control significantly improved during the 4-year follow up, but those of the body weight and BMI values did not. Furthermore, the percentages of performance indicators matching the expected rate of recurrence per each year of follow-up significantly improved during the study period. CONCLUSIONS: Long-term glycemic control and the performance indicators relating to the type 2 diabetic patients participating in our shared care programme progressively improved.

Characteristics of some wheat-based foods of the Italian diet in relation to their influence on postprandial glucose metabolism in patients with type 2 diabetes.

The present study was aimed at evaluating in patients with type 2 diabetes: (1) the glycaemic response to four starchy foods based on wheat, typical of the Italian diet; (2) the importance of some food characteristics in relation to their effects on postprandial glucose response. Seventeen patients with type 2 diabetes (eleven men and six women) participated in the study. All patients consumed, in random order and on alternate days, 50 g available carbohydrate provided by 90 g white bread and, according to a randomised procedure, an equivalent amount of carbohydrate provided by one (n 8) or two (n 9) of three other different test foods (g): pizza 85, potato dumplings 165, hard toasted bread 60. Foods had a similar nutrient composition. Plasma glucose response, measured for 180 min, was significantly lower after the potato dumplings than after white bread at 90 (P < 0.05), 120 (P < 0.01), and 150 (P < 0.05) min. No difference was observed in postprandial plasma insulin response after the various test foods. The percentage of starch hydrolysed after 5 h in vitro hydrolysis with alpha-amylase was about 30 % lower for potato dumplings than for the other foods. However, no differences in the resistant starch content, the rate of diffusion of simple sugars added to a dialysis tube containing the food, and the viscosity of digesta were observed among the test foods. Scanning electron microscopy of potato dumplings showed a compact structure compatible with impaired accessibility of starch to digestive enzymes. In conclusion, carbohydrate-rich foods typical of the Italian diet which are often consumed as an alternative to pasta dishes are not equivalent in terms of metabolic impact in diabetic patients. Due to their low blood glucose response, potato dumplings represent a valid alternative to other starchy foods in the diabetic diet. Food structure plays an important role in determining starch accessibility to digestion, thus influencing the postprandial blood glucose response.

Large-scale hormone replacement therapy and life expectancy: results from an international comparison among European and North American populations.

OBJECTIVES: An analysis was performed to determine the risks and benefits of a 10-year hormone replacement therapy regimen that had been applied to all women at 50 years of age in 8 countries. METHODS: Cumulative mortality with and without hormone replacement therapy over 20 years was estimated, with both current and predicted total and disease-specific secular mortality trends and the influence of a generational cohort effect taken into account. RESULTS: In countries with high ischemic heart disease frequency and predictable relative predominance of ischemic heart disease rates over breast cancer rates for the next 20 years, hormone replacement therapy could result in benefits with regard to overall mortality; this advantage decreases in younger-generation cohorts. In countries in which breast cancer mortality predominates over ischemic heart disease in early postmenopause and in which the predictable trends for both diseases reinforce this condition, a negative effect on overall mortality would be observed. In the United States, the effect of large-scale hormone replacement therapy would change over time. CONCLUSIONS: The long-term effect of hormone replacement therapy on life expectancy of postmenopausal women may vary among countries.

High endogenous estradiol is associated with increased venous distensibility and clinical evidence of varicose veins in menopausal women.

OBJECTIVE: The purpose of this study was to determine if there is an association between elevated sex hormones (ie, serum estradiol, sex hormone binding globulin [SHBG], testosterone) and increased venous distension and clinical evidence of varicose veins in menopausal women. METHODS: Participants were 104 healthy volunteer menopausal women, aged 48 to 65 years, who were not undergoing hormonal treatment. Of these 104, 14 were excluded from analyses because their estradiol levels were compatible with a premenopausal condition (4), because they had missing values for insulin concentration (5), and because they did not show up at venous vessel examination (5). Patients underwent a physical examination to determine the presence of varicose veins; a venous strain-gauge plethysmographic examination to compute instrumental measures of venous distensibility; and laboratory analyses of blood so serum testosterone, estradiol, SHBG, glucose, and insulin could be measured. There were also prevalence ratios and odds ratios used to test the presence of an association between biochemical and instrumental variables. RESULTS: Serum levels of estradiol in the upper tertile of the frequency distribution were significantly associated with clinical evidence of varicose veins (prevalence odds ratios 3.6; 95% CI 1.1-11.6) and with increased lower limb venous distensibility (prevalence odds ratios 4.4; 95% CI 1.2-15.5). No association was found for SHBG and testosterone. CONCLUSIONS: Our finding that high serum levels of estradiol are associated with clinical evidence of varicose veins and instrumental measurements indicating increased venous distensibility in menopausal women suggests that endogenous estrogens may play a role in the development of this very common venous vessel abnormalities.

Does a high-carbohydrate diet have different effects in NIDDM patients treated with diet alone or hypoglycemic drugs?

OBJECTIVE: To compare the effects of a nigh-carbohydrate diet on blood glucose and plasma lipids in NIDDM patients with either mild or severe glucose intolerance. RESEARCH DESIGN AND METHODS: A crossover design with a 15-day intervention diet was used. Eighteen patients were separated into two groups on the basis of hypoglycemic treatment (diet, n = 9, or diet plus glibenclamide, n = 9) and were assigned to a 15-day treatment with a high-carbohydrate/low-fiber diet containing 60% energy from carbohydrate and 20% from fat or a low-carbohydrate/low-fiber diet with 40% energy from carbohydrate and 40% from fat and then crossed over to the other diet for 15 more days. RESULTS: The high-carbohydrate diet produced a significant increase in postprandial blood glucose in patients on glibenclamide (13.6 +/- 1.4 vs. 11.0 +/- 1.8 mmol/l, P < 0.002, while no difference was recorded in the group on diet alone (9.7 +/- vs. 8.9 +/- 0.6 mmol/l). Postprandial insulin levels were significantly higher after the high-carbohydrate diet in the group on diet along (248 +/- 32 vs. 192 +/- 28 pmol/l, P < 0.01), while no significant differences were observed in the other group (226 +/- 19 vs. 202 +/- 24 pmol/l) The high-carbohydrate diet also induced a significant increase in fasting plasma triglyceride concentrations in both groups (1.36 +/- 0.2 vs. 1.12 +/- 0.2 mmol/l, P < 0.05 and 1.4 +/- 0.3 vs. 1.1 +/- 0.1 mmol/l, P < 0.05). No differences were observed in fasting plasma cholesterol and HDL. CONCLUSIONS: The effects of the high-carbohydrate diet on blood glucose control in NIDDM patients differ according to severity of glucose intolerance.

A high-monounsaturated-fat/low-carbohydrate diet improves peripheral insulin sensitivity in non-insulin-dependent diabetic patients.

It is commonly believed that high-carbohydrate (CHO) diets improve peripheral insulin sensitivity; however, this concept is based on anecdotal evidence. Furthermore, it has been demonstrated that in non-insulin-dependent diabetic patients treated with insulin, a high-monounsaturated-fat (MUFA) diet is more effective than a high-complex-CHO diet in reducing blood glucose levels. The aim of our study was to compare the effect of a high-MUFA diet and a high-CHO diet on peripheral insulin sensitivity and metabolic control in non-insulin-dependent diabetic patients. Ten non-insulin-dependent diabetic patients aged 52 +/- 8 years with a body mass index (BMI) of 26.7 +/- 3.5 kg/m2 who were being treated with diet alone (n = 5) or with diet plus glibenclamide (n = 5) were randomly assigned to a 15-day period of either a high-MUFA/low-CHO diet (CHO, 40%; fat, 40%; protein, 20%; fiber, 24g) or a low-MUFA/high-CHO diet (CHO, 60%; fat, 20%; protein, 20%; fiber, 24g) and were then crossed-over to the other diet. Diets were similar in their content of monosaccharides, disaccharides, and saturated fats, and were administered to the patients in a metabolic ward. The dosage of hypoglycemic drugs was maintained at a constant level throughout the study. With the high-MUFA/low-CHO diet, a decrease in both postprandial glucose (8.76 +/- 2.12 v 10.08 +/- 2.76 mmol/L; P < .05) and plasma insulin (195.0 +/- 86.4 v 224.4 +/- 75.6 pmol/L; P < .02) levels was observed. Furthermore, fasting plasma triglyceride levels were reduced after the high-MUFA fat/low-CHO diet (1.16 +/- 0.59 v 1.37 +/- 0.59 mmol/L; P < .01).(ABSTRACT TRUNCATED AT 250 WORDS)