Search

Aims To investigate whether the satiety-inducing agent sibutramine affected body weight and associated anthropometry in overweight and obese (body mass index (BMI) > 27) Type 2 diabetic patients on sulphonylurea therapy. Methods A randomized, placebo-controlled trial was undertaken in 134 patients with stable metabolic control on chronic sulphonylurea therapy. Patients were placed on moderate caloric restriction and received treatment with either sibutramine (15 mg/day) or placebo for 6 months. Results Fifty-three of 69 sibutramine-treated and 57/65 placebo-treated patients completed the study. Both groups showed progressive weight loss. At the end of the trial weight loss was two times greater in the sibutramine group (mean ± sem; −4.5 ± 0.5 kg) than placebo (−1.7 ± 0.5 kg, P 5% of initial body weight in the sibutramine group than placebo. BMI (P

The aim was to investigate sulodexide as a possible therapeutic tool for treating micro- and macroalbuminuria in diabetic patients. Fifteen patients (13 micro- and 2 macroalbuminuric) with Type II diabetes, were treated with 600 lipoprotein-lipase releasing units of sulodexide by the intramuscular route, daily for 28 days, and followed up for 2 months. The main evaluation parameter was the albumin excretion rate. At the end of treatment, six of the 13 microalbuminuric patients showed a decrease in the albumin excretion rate, which increased again in three of the six during follow-up. In the two macroalbuminuric patients the albumin excretion rate decreased at the end of treatment and remained unchanged after a further 2 months. Overall analysis (15 patients) showed a significant decrease ( P < 0.05) in the albumin excretion rate compared with baseline. Metabolic control and blood pressure remained unchanged during the entire period of study. No adverse events were registered. It is concluded that sulodexide administration has a favourable effect in reducing the albumin excretion rate in Type II diabetic patients with micro- and macroalbuminuria.

Health-related quality of life (HRQL) is poor in obese patients and not necessarily related to the severity of disease. In a large proportion of patients psychopathological distress is also present and its role on poor HRQL has never been quantified.In 207 patients entering a University-based weight-reducing programme (38 males, 169 females), a package of self-administered questionnaires was submitted to measure HRQL (Short-Form 36) and psychopathological distress [general: Symptom Check-List 90 (SCL-90); depression: Beck Depression Inventory (BDI); binge eating: Binge Eating Scale (BES)]. Several clinical and anthropometric data were also recorded.HRQL, both in its physical and mental component, was significantly reduced in obesity when related to Italian population norms. SCL-90 identified psychopathological distress in 53 patients (26%), the BDI was indicative of depression in 89 cases (43%), whereas high scores of the BES were measured in 88 cases. Logistic regression analysis identified psichopathological distress as the major factor associated with poor HRQL.Psychiatric disturbances significantly contribute to poorly perceived health status. Only a comprehensive treatment including a specific approach to psychiatric symptoms may be effective in improving the perceived health status of obese patients seeking treatment.

To investigate whether the satiety-inducing agent sibutramine affected body weight and associated anthropometry in overweight and obese (body mass index (BMI)27) Type 2 diabetic patients on sulphonylurea therapy.A randomized, placebo-controlled trial was undertaken in 134 patients with stable metabolic control on chronic sulphonylurea therapy. Patients were placed on moderate caloric restriction and received treatment with either sibutramine (15 mg/day) or placebo for 6 months.Fifty-three of 69 sibutramine-treated and 57/65 placebo-treated patients completed the study. Both groups showed progressive weight loss. At the end of the trial weight loss was two times greater in the sibutramine group (mean +/- SEM; -4.5 +/- 0.5 kg) than placebo (-1.7 plus minus 0.5 kg, P0.001 vs. sibutramine). There was a trend for more patients to lose5% of initial body weight in the sibutramine group than placebo. BMI (P0.001) and waist circumference (P0.001) were also decreased to a greater extent by sibutramine. Mean reductions in HbA(1c) were commensurate with weight loss in both the sibutramine and placebo (- 0.78 +/- 0.17% and -0.73 +/- 0.23%; P = 0.84). Sibutramine was well tolerated with only two patients withdrawn due to potentially drug-related serious adverse events (palpitations).Sibutramine, in conjunction with moderate caloric restriction, enhances weight loss and reduces waist circumference in overweight and obese Type 2 diabetic patients receiving sulphonylurea therapy. This is associated with additional improvements in glycaemic control in a limited number of patients losingor = 10% of their baseline body weight.

Insulin sensitivity (euglycemic clamp, insulin infusion rate: 40 mU. m(-2). min(-1)) was studied in 30 subjects with biopsy-proven nonalcoholic fatty liver disease (NAFLD), normal glucose tolerance, and a BMI30 kg/m(2). Of those 30 subjects, 9 had pure fatty liver and 21 had evidence of steatohepatitis. In addition, 10 patients with type 2 diabetes under good metabolic control and 10 healthy subjects were studied. Most NAFLD patients had central fat accumulation, increased triglycerides and uric acid, and low HDL cholesterol, irrespective of BMI. Glucose disposal during the clamp was reduced by nearly 50% in NAFLD patients, as well as in patients with normal body weight, to an extent similar to that of the type 2 diabetic patients. Basal free fatty acids were increased, whereas insulin-mediated suppression of lipolysis was less effective (-69% in NAFLD vs. -84% in control subjects; P = 0.003). Postabsorptive hepatic glucose production (HGP), measured by [6,6-(2)H(2)]glucose, was normal. In response to insulin infusion, HGP decreased by only 63% of basal in NAFLD vs. 84% in control subjects (P = 0.002). Compared with type 2 diabetic patients, NAFLD patients were characterized by lower basal HGP, but with similarly reduced insulin-mediated suppression of HGP. There was laboratory evidence of iron overload in many NAFLD patients, but clinical, histological, and biochemical data (including insulin sensitivity) were not correlated with iron status. Four subjects were heterozygous for mutation His63Asp of the HFE gene of familiar hemochromatosis. We concluded that NAFLD, in the presence of normoglycemia and normal or moderately increased body weight, is characterized by clinical and laboratory data similar to those found in diabetes and obesity. NAFLD may be considered an additional feature of the metabolic syndrome, with specific hepatic insulin resistance.

A poor health-related quality of life (HRQL) has been repeatedly documented in obesity. Overweight per se and associated diseases affect physical fitness, whereas mental well-being depends on social, cultural and behavioural components. Very few studies are available on HRQL in obese persons in relation to eating behaviour. We measured HRQL by means of Short-Form-36 questionnaire in 183 obese subjects, seeking specific treatment at a University-based weight management center. Only half had a Body Mass Index exceeding 35 kg/m2. Data were compared to age- and gender-adjusted normative values of the Italian population (2031 subjects). The Binge Eating Scale (BES) and the Three-Factor Eating Questionnaire (TFEQ) were used to assess eating behaviour. Most domains of HRQL were impaired in obese subjects, more severely in younger subjects and in females. The severity of overweight progressively affected physical fitness, but had a minor effect on mental status. In over 50% of subjects, BES and TFEQ identified a binge eating pattern, more frequently in females. A positive BES, as well as lower restriction, higher disinhibition and hunger values at TFEQ, identified subjects with poorer HRQL. Logistic regression analysis identified in a positive BES the variable more closely associated with low scores in mental domains of perceived HRQL. Waist-to-hip ratio, degree of obesity, osteoarticular and respiratory diseases, but also positive BES, were selected as variables more closely associated with poor physical fitness. HRQL is variably impaired in obese persons seeking treatment for their disease, mainly in patients with binge eating. Treatment of binge eating may be as important as any weight-reducing intervention for the overall well-being of the majority of obese persons.

During the last 20 years there has been much interest in nutritional treatment for patients with advanced cirrhosis. Most studies have measured the potential benefit of nutritional supplements of dietary proteins, generic protein hydrolysates, or specific branched-chain amino acid (BCAA)-enriched formulas in regard to nutritional parameters and hepatic encephalopathy. The issue is not definitively settled; data are conflicting and meta-analyses have failed to produce unequivocal results. A consensus review, recently produced under the auspices of the European Society for Parenteral and Enteral Nutrition, concluded that: (1) patients with cirrhosis tend to be hypermetabolic, and a higher-than-normal supply of dietary proteins is needed to achieve nitrogen balance; (2) most patients tolerate a normal or even increased dietary protein intake, without risk of hepatic encephalopathy; (3) a modified eating pattern, based on several meals and a late evening snack, is useful; (4) in severely malnourished patients, amino acid supplements may be considered to provide the necessary amount of proteins to meet protein requirements; (5) in a few patients intolerant to the required protein intake, BCAA supplements may be considered to provide the necessary nitrogen intake without detrimental effects on the mental state, perhaps even improving it. Future studies are needed to quantify the advantage of nutritional support with amino acids or BCAA supplements on overall well-being, complications, and ultimately survival with a long-lasting disease where self-perceived health-related quality of life is a major outcome.

Summary There is no established treatment for steatohepatitis in patients who are not alcoholics. This disease is a potentially progressive liver disease associated with hepatic insulin resistance. Only a weight-reducing diet in overweight patients has proved effective. We treated 20 patients who had steatohepatitis but were not alcoholics with metformin (500 mg three times a day for 4 months), an agent that improves hepatic insulin sensitivity. When compared with the six individuals not complying with treatment, long-term metformin significantly reduced mean transaminase concentrations, which returned to normal in 50% of actively-treated patients. Also, insulin sensitivity improved significantly and liver volume decreased by 20%. Similar data have been reported in insulin-resistant ob/ob mice with fatty liver. A randomised-controlled study is needed.

On 5 and 6 April 1991, at the National Research Council (CNR) in Rome, a Consensus Conference on the relationship between overweight, obesity and health was held. The conference was sponsored by FATMA (Applied Project on Disease Factors of the CNR) and UICO (Italian Society for the Study of Obesity) with the purpose of establishing guidelines for health employees. The development of the conference followed the methodology set down by OMAR to obtain a rational and significant consensus on the answers to six basic questions prepared by the planning committee. The questions were the pivotal point of the conference and were brought to the attention of all the attendees and widely diffused among the medical community; they were proposed with the aim of giving an exhaustive definition of obesity, to investigate its relationship with mortality and morbidity, to highlight its social characterization, to indicate methods of evaluation and recommendations for weight loss, to select groups at risk, and to focus general guidelines for research. After the presentation of the state of the art on 18 topics by experts in the field, the 22 members of the consensus panel, impartial experts from a vast area of the scientific community, discussed a draft document representing the answers to the questions, which was subsequently submitted to the 307 attendees, discussed and then approved. This paper is the definitive document of the Consensus Conference. The introduction explains the reasons which led to the decision to promote the conference six years after the one held in the United States. The methodology is then set out. The questions are answered in the form of recommendations and backed up by data and scientific evidence from the literature.

On April 5th and 6th 1991, at the National Research Council (CNR) in Rome, a Consensus Conference on the relationship between Overweight, Obesity and Health was held. The Conference was sponsored by FATMA (Applied Project on Disease Factors of the CNR) and UICO (Italian Society for the Study of Obesity) with the purpose of establishing guidelines for health employees. The development of the Conference followed the methodology set down by OMAR to obtain a rational and significant consensus on the answers to 6 basic questions prepared by the Planning Committee. The questions were the pivotal point of the Conference and were brought to the attention of all the attendees and widely diffused among the medical community; they were proposed with the aim of giving an exhaustive definition of obesity, to investigate its relationship with mortality and morbidity, to highlight its social characterization, to indicate methods of evaluation and recommendations for weight loss, to select groups at risk, and to focus general guidelines for research. After the presentation of the state of the art on 18 topics by experts in the field, the 22 members of the Consensus Panel, impartial experts from a vast area of the scientific community, discussed a draft document representing the answers to the questions, which was subsequently illustrated to the 307 attendees, discussed and then approved. This paper is the definitive document of the Consensus Conference. The introduction explains the reasons which led to the decision to promote the Conference six years after the one held in the United States. The methodology is then set out. The questions are answered in the form of recommendations and backed up by data and scientific demonstrations from the literature.

The aim of this study was to assess the correlation between the distribution of adipose tissue, sexual hormones and hyperinsulinemia in male obesity. Fifty-two obese males, aged 40.0 +/- 10.9 years old and with a body mass index (BMI) of 35.0 +/- 6.1 (m +/- SD), not suffering from diabetes or any other endocrine disease, were included in the study. A group of 20 subjects aged 30.5 +/- 7.9 (p less than 0.005 vs obese subjects) and with a BMI of 23.0 +/- 2.0 were used as controls. Body fat distribution was assessed using the waist/hip ratio (w/h ratio): 0.985 +/- 0.052 in obese subjects and 0.913 +/- 0.061 in controls (p less than 0.005). In comparison to control subjects, significantly lower levels of total (T) (357 +/- 132 vs 498 +/- 142 ng/dl; p less than 0.005) and free testosterone (FT) (14.2 +/- 2.9 vs 17.1 +/- 2.6 pg/ml; p less than 0.05) were found in the obese group, as well sex hormone binding globulin (SHBG) (41.7 +/- 31.9 vs 66.2 +/- 18.6 nmol/l; p less than 0.001). None of the other steroids (androstenedione, dehydroepiandrosterone-sulphate, estrone, 17 beta-estradiol, dihydrotestosterone) or FSH and LH gonadotropins assayed differed between the two groups. Significantly higher levels of insulin and C-peptide, both fasting and after a oral glucose tolerance test, were also found in obese subjects.(ABSTRACT TRUNCATED AT 250 WORDS)

The role of weight loss in the therapy of obstructive sleep apnea syndrome (OSAS) was investigated in 23 affected patients with various degrees of obesity (body mass index range 26.6-61.0) free of cranio-facial malformations. Weight loss resulted 18.5 +/- 14.7 (s.d.) kg and was significantly correlated with baseline BMI value (r = 0.94; P less than 0.0001). Weight loss significantly reduced the number of apneas + hypopneas per hour of sleep ((A + H)I) from 66.5 +/- 23.0 to 33.0 +/- 26.2 (P less than 0.0001) and improved the mean of oxygen desaturation peaks during apneas (mSaO2) from 81.9 +/- 6.9 to 87.6 +/- 3.9; P less than 0.001). A significant correlation was found between weight loss and changes in the (A + H)I (r = -0.55; P less than 0.01) and the mSaO2 (r = 0.46; P less than 0.05). The (A + H)I significantly improved in both patients who lost more than 10 kg (basal BMI: 42.3 +/- 10.0) and in those who lost less than 10 kg (basal BMI: 30.2 +/- 2.3), whereas the mSaO2 improved only in the former. Obese patients with moderate to heavy ORL pathological findings had worse pretreatment and final OSAS parameters than those with absent or mild ORL lesions. However, both groups showed a significant, although quantitatively different, improvement of the (A + H)I and mSaO2 after weight loss. Compared to those who were cured or improved after the treatment, patients who failed to obtain significant effects on OSAS clinical presentation also had a significantly higher prevalence of ORL pathology. It is concluded that: (1) weight loss improves parameters and clinical presentation of OSAS in the majority of affected obese patients; (2) a relationship exists between the entity of weight loss and that of improvement of the syndrome; (3) weight loss must be encouraged even in patients with mild to moderate overweight; (4) the presence of ORL pathology may represent a confusing factor in the interpretation of the results obtained after weight loss.

10 patients with type 2 diabetes mellitus, in stable weight and diet therapy, followed a 2 months nutritional supplementation with guar, 15 g/day. Their previous nutritional and pharmacological therapy was not modified throughout the study. No changes occurred in body weight or major parameters of metabolic control. However, a significant fall occurred in fasting plasma, total and LDL cholesterol, and apolipoprotein B concentrations. Insulin sensitivity, measured by the "steady state plasma glucose", obtained after a 150 min glucose-insulin-somatostatin infusion, improved in all patients but two. A significant correlation was observed between steady state plasma glucose variations, the glycosylated haemoglobin A1c (r = 0.70; p less than 0.005), total (r = 0.77; p less than 0.001), and LDL cholesterol (r = 0.69; p less than 0.005) and apolipoprotein B concentrations (r = 0.75; p less than 0.005).

In order to evaluate slimming effects on certain metabolic (cholesterol, triglycerides, basal insulinaemia) and haemorheologic (haematocrit, fibrinogen, whole blood viscosity and plasma viscosity) rates, we studied 24 obese subjects (15 female and nine male) aged 25-58, with BMI ranging from 35.5 to 67, before and after a hypocaloric diet period involving a 20-kg weight loss. All subjects underwent blood sampling to assess: OGTT, plasma proteins, serum total cholesterol, HDL-cholesterol, serum triglycerides, haematocrit, whole blood viscosity at high and low shear rate with and without correction of 45 per cent haematocrit, plasmatic capillary viscosity and fibrinogen level. Our study showed no significant changes in plasma proteins, serum HDL-cholesterol, haematocrit, fibrinogen and whole blood viscosity at high and low shear rate, while basal insulinaemia, total cholesterol, triglycerides, low shear rate corrected at 45 per cent haematocrit blood viscosity and capillary plasmatic viscosity are significantly reduced. However the analysis of possible relation between the differences of assessed rates before and after slimming has shown no significant correlations. In conclusion, we can say that the slimming of very obese subjects improves blood and plasma viscosity, but the mechanism by which this improvement occurs is not the one which usually affects the determination of these rates.

In this study, 16 overweight or obese NIDDM patients with a long period of stable weight and dietary surveillance were treated with 150 mg t.i.d. of Benfluorex per os for 3 months. A significant improvement occurred in the fasting and post-meal glucose levels and in the HbA1C values, regardless of weight changes that occurred throughout the study. No significant changes were found in the fasting or meal-stimulated insulin (IRI) levels and in the glucose:IRI molar ratios. On the contrary, there were no significant variations in C-peptide levels while the glucose:CPR ratio appeared to decrease while on Benfluorex. In basal conditions, 11 patients presented insulin insensitivity (as measured by the glucose-insulin-somatostatin technique) which was unaffected by the pharmacological treatment. Benfluorex may therefore ameliorate metabolic control in overweight or obese NIDDM patients, but our data do not clarify whether its effects are mediated by an improvement in the action of insulin in peripheral tissues.

A double-blind controlled study was performed in unselected obese outpatients to assess the effects of ephedrine on weight loss. Patients were treated for 3 months with placebo (group I), 25 mg t.i.d. or 50 mg t.i.d. of ephedrine hydrochloride orally administered (groups II and III, respectively). Dietary treatment consisted of 1000 kcal/day for females and 1200 kcal/day for males. The three groups were matched for age, sex, body mass index and pre-treatment spontaneous caloric intake. Weight loss was similar in all groups. Patients in group III (ephedrine 150 mg/day) showed significantly more side effects than the placebo group. These results do not seem to favour the hypothesis that ephedrine, a thermogenic agent, may be effective in the therapy of unselected simple obesity. On the other hand, it cannot be excluded that the drug may be useful in obese patients in whom defective thermogenesis may be clearly demonstrated.

A double-blind cross-over randomized study was performed in 10 selected adult overweight and obese (body mass index greater than 27) women who had been adapted to low-energy intake for a long period of time and who had shown difficulty in losing weight with conventional hypocaloric treatment. Combined with diet therapy (1000-1400 kcal/day), l(-)ephedrine hydrochloride (50 mg three times a day per os) or placebo were administered daily before each meal, after a period of stabilization with diet only for 1 month. Each pharmacological treatment lasted for 2 months. Weight loss was significantly (P less than 0.05) greater during the ephedrine period (2.41 +/- 0.61 kg) than during the placebo period (0.64 +/- 0.50 kg). None of the patients presented clinically important side-effects. These preliminary results seem to suggest a possible role for a thermogenic compound such as ephedrine in promoting weight loss in low-energy-adapted obese women.

The above study was carried out in a population sample of 1250 elderly subjects living at home, from five Italian regions (Budrio in Emilia-Romagna, Ponte S. Nicolò in Veneto, Bernareggio in Lombardy, Sezze in Latiumm, Melito in Campania). The results obtained lead to the following conclusions: 1. The condition of loneliness appears to have a detrimental influence on health in both sexes. Among other consequences, loneliness leads to progressive spontaneous reduction of daily milieu and social requirements, as well as to an impression of dependence that cannot be easily overcome. 2. The study of the relationship between the presence or absence of chronic pathologies and legal title of domicile has shown that if the home is their own by legal property or usufruct this has a favorable influence, especially in males. Property also satisfies emotional needs, through the profound ties between personal history and certain places. 3. Positive changes in life style may have beneficial effects on the interaction between socio-economic variables and the onset of chronic pathologies, especially in old age.