Treatment of morbid obesity with intragastric balloon in association with diet.

BACKGROUND: The BioEnterics Intragastric Balloon (BIB, BioEnterics, Santa Barbara, CA) in association with restricted diet has been used for the treatment of obesity and morbid obesity. METHODS: Since March 1998, 322 BIB were placed in 281 obese and morbidly obese patients; 73 patients were male and 208 female; mean age was 41.6 years (21-70); mean weight was 117.4 kg (67-229); mean BMI was 41.8 kg/m2 (29-81); % excess weight was 62% (10-216). The balloon was inserted and removed endoscopically under general anesthesia. Patients were given a balanced diet of 1000 kcal/day. Also, for 18 months we compared 42 obese patients treated only with 1000 kcal/day diet (group A) with 31 obese patients subjected to BIB for 4 months + 1000 kcal/day diet (group B). RESULTS: After 4 months of balloon treatment, the mean weight loss was 13.9 kg and the mean reduction in BMI was 4.8. Weight loss was greater in male patients. Weight loss was accompanied by an improvement of the diseases associated with obesity, in particular diabetes. In the diet vs BIB + diet study, BIB with diet produced a greater weight loss in a shorter time than diet alone. CONCLUSION: The best indications for BIB were: morbidly obese opatients (BMI > 40) and super-obese patients (BMI > 50) in preparation for bariatric operations; obese patients with BMI 35-40 with co-morbilities in preparation for bariatric surgery; obese patients with BMI 30-35 with a chronic disease otherwise unresolved; patients with BMI < 30 only in a multidisciplinary approach.

Thirty months experience with laparoscopic adjustable gastric banding.

INTRODUCTION: Since June 1996 we performed laparoscopic adjustable silicone gastric banding (LASGB), because of low invasivity, absence of malabsorption, reversibility, and postoperative regulation. MATERIALS AND METHODS: Criteria included body mass index (BMI) >40 or >35 with serious obesity-related conditions. 154 patients underwent LASGB. BMI ranged from 35 to 65.7 (mean 43.7+/-6.2). RESULTS: The laparoscopic procedure was successfully completed in 150 patients (97.4%). One patient was converted to the laparotomic procedure because of hepatomegaly; 4 patients had to be converted for gastric laceration during the laparoscopic approach. In one of these patients, the band was removed 7 days later for sepsis, followed by an uneventful postoperative course. The mean length of postoperative hospitalization was 2.3+/-0.9 days. Per cent of excess weight loss was 42.5+/-22.4 after 1 year. CONCLUSIONS: LASGB was feasible and effective.

Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus: a placebo-controlled, double-blind, multicentre study.

AIMS: The aim of the study was to evaluate the efficacy and safety of acarbose in patients with Type 1 diabetes mellitus (DM). METHODS: A multicentre double-blind, randomized, placebo-controlled study was performed. After a 6-week run-in, 121 patients were randomized to acarbose or placebo and to high- or low-fibre diet for 24 weeks. Acarbose dose was 50 mg t.d.s. for the first 2 weeks and 100 mg t.d.s. for the subsequent weeks. RESULTS: At the end of 24 weeks of treatment the intention to treat analysis showed that acarbose compared with placebo decreased 2 h postprandial plasma glucose levels (12.23 +/- 0.83 vs. 14.93 +/- 0.87 mmol/l; F = 6.1, P < 0.02) (least square means +/- SEM). No significant effect of acarbose was recorded on HbA1c or on the number of hypoglycaemic episodes. The effect of acarbose on blood glucose control was not influenced by the amount of carbohydrate and/or fibre intake. The incidence of adverse events were 75% and 39% in acarbose and placebo groups, respectively; they were mild and confined to the gastrointestinal tract. CONCLUSIONS: The use of acarbose in combination with insulin reduces postprandial plasma glucose levels in Type 1 diabetic patients who are not satisfactorily controlled with insulin alone but without significant effect on HbA1c.

Hypocaloric high-protein diet improves glucose oxidation and spares lean body mass: comparison to hypocaloric high-carbohydrate diet.

The aim of the study was to investigate the effects of two hypocaloric (800-kcal) diets on body weight reduction and composition, insulin sensitivity, and proteolysis in 25 normal glucose-tolerant obese women. The two diets had the following composition: 45% protein, 35% carbohydrate (CHO), and 20% fat (HP diet, 10 subjects), and 60% CHO, 20% protein, and 20% fat (HC diet, 15 subjects); both lasted 21 days. A euglycemic hyperinsulinemic (25 mU/kg/h) clamp lasting 150 minutes combined with indirect calorimetry was performed before and after the diet. Both diets induced a similar decrease in body weight and fat mass (FM), whereas fat-free mass (FFM) decreased only after the HC diet. 3-Methylhistidine (3-CH3-HIS) excretion was reduced by 48% after the HP diet and remained unchanged after the HC diet (P < .05). A significant correlation was found between the changes in FFM and in 3-CH3-HIS excretion after the diet (rs = .50, P < .02). Blood glucose remained unchanged, while insulin decreased in both diets. Free fatty acids (FFA) significantly increased only after the HC diet (P < .05). During the clamp period, glucose disposal and glucose oxidation significantly increased after the HP diet and significantly decreased after the HC diet. Opposite results were found when measuring lipid oxidation. In conclusion, our experience suggests that (1) a hypocaloric diet providing a high percentage of natural protein can improve insulin sensitivity; and (2) conversely, a hypocaloric high-polysaccharide-CHO diet decreases insulin sensitivity and is unable to spare muscle tissue.

[Acute carbamazepine poisoning treated with plasmapheresis. Description of a clinical case]. / Intossicazione acuta da carbamazepina trattata con plasmaferesi. Descrizione di un caso clinico.

A case of severe Carbamazepine poisoning initially misdiagnosed is reported. Treatment consisted in plasmapheresis (3.5 liters exchanged) repeated for 3 consecutive days, in conjunction with activated charcoal and advanced life support. It was obtained a rapid decay in Carbamazepine plasmatic level (with rebound phenomenon only after first treatment day) and a contemporary improvement in clinical conditions. The patient was discharged without complications after 6 days stay in ICU. Taking pharmacokinetic characteristics into account, it is suggested that plasmapheresis may be useful in this kind of poisoning.

Peritoneal and subcutaneous absorption of insulin in type I diabetic subjects.

We and others have shown that in type I diabetes, ip insulin delivery results in lower free insulin levels than sc delivery. The aim of this study was to compare the rate of appearance of insulin in the peripheral circulation during ip and sc insulin administration in type I diabetes, in steady state and nonsteady state. To do this, we determined free insulin levels during ip or sc infusion as well as the impulse response of the insulin system after iv injection of a 6-nmol bolus of insulin. Twelve hours after a constant basal insulin infusion (5.5 +/- 1.4 nmol/h) was started, five C-peptide-negative type I diabetic subjects showed a lower systemic rate of appearance of insulin (expressed as a percentage of the administered dose) with ip than sc administration (27 +/- 6% vs. 40 +/- 10%; P < 0.001). In nonsteady state, when the infusion rate was increased from basal to 15 nmol/h (0-150 min) and subsequently to 42 nmol/h (150-300 min), the percent increase in insulin's systemic rate of appearance was higher with ip than sc infusion (P < 0.05 from 60-150 min; P < 0.01 from 150-300 min), indicating faster absorption. Thus, we conclude that insulin is more rapidly absorbed from the peritoneal cavity than from sc tissue. However, with ip administration, a sizable amount of insulin, once absorbed, is extracted before reaching the peripheral circulation, most likely by the liver. This is indirect evidence that ip insulin delivery results in a portal-peripheral insulin gradient in humans.

Bioelectrical impedance in the evaluation of the nutritional status of hemodialyzed diabetic patients.

Bioelectrical impedance is a technique allowing a quick, repeatable and reliable assessment of body composition. This method was applied to detect total body water (TBW), fat (FAT) and fat-free mass (FFM) in 80 normal subjects, 65 diabetic (45 insulin-dependent [IDD], 20 non insulin-dependent [NIDD]) and 34 uremic diabetic patients (20 IDD, 14 NIDD) submitted to hemodialysis three times a week. Uremic patients were tested at the end of the dialytic session. Multivariated analysis adjusted for age, sex and disease showed the following results: body mass index (BMI) increased with age (p < 0.005) and in the presence of NIDD (p < .001); TBW was lower in nephropathic patients (p < 0.05) and in the female sex (p < 0.0001); FFM decreased with age (p < 0.005), female sex (p < 0.0001) and in nonuremic NIDD (p < 0.001). Correspondingly FAT increased with age (p < 0.005), female sex (p < 0.0001) and in nonuremic NIDD (p < 0.001). Sixteen uremic subjects, randomly selected from both IDD and NIDD groups, tested at the beginning and at the end of the same hemodialytic session, showed a significant decrease of TBW which corresponded to the correction of their overhydratation. In our patients uremia does not seem to influence the nutritional status and the bioelectrical analysis could be applied to determine the real dry weight in hemodialyzed diabetic patients.

[Loco-regional analgesia with continuous peridural technique in labor. Evaluation of 4 years of experience]. / Analgesia loco-regionale con tecnica peridurale continua nel travaglio di parto. Valutazione di 4 anni di attività.

The Authors report on the results of their experience using local-regional analgesia performed with the continuous peridural technique over four years of activity with 503 pregnant women. Protocols used over the years called for morphine-fentanyl association, but bupivacaine 0.25% plus fentanyl and bupivacaine 0.125% plus fentanyl mixtures were then employed. In order to evaluate the efficiency of this procedure, the following data were recorded for each patient undergoing the analgesia: duration of labor prior to the effect of the analgesia; time to reach complete dilatation from a 3 cm dilatation; the length of time of the expulsive phase; manifestation of side effects and complications; vacuum utilization. Furthermore, Apgar scores were taken for all newborn babies at 1st and 5th minutes. The data were then compared with those recorded for a group of women with the same obstetrical characteristics who were not treated with analgesia. The comparison showed that the length of time of the dilatation phase (from 3 to 10 cms) was significantly less in the group of treated patients, while the expulsive phase was basically similar in both groups, thus showing that labor mean time had significantly decreased in the group of patients treated with analgesia. The number of vacuum births was basically the same in both groups and comparable to the data available in the literature. These were practically no side effects or complications. In conclusion, our experience confirms the fact that this method is the most reliable in terms of safety, effectiveness and acceptability on the part of women compared to any other analgesic treatment employed during labor.

Effect of soya and cellulose fibers on postprandial glycemic response in type II diabetic patients.

OBJECTIVE: We studied the effect on serum glucose and insulin of a preprandial ingestion of 7 g of soya fibers or of an equal amount of purified cellulose on eight non-insulin-dependent (type II) diabetic patients. RESEARCH DESIGN AND METHODS: Four tests were conducted in each patient in random order. In the first study, soya or cellulose was ingested before a standard breakfast, and postprandial glucose and insulin curves were determined. In the second study, intestinal absorption was investigated by means of a standard D-xylose absorption excretion test after the ingestion of soya or cellulose. RESULTS: Insulin profiles did not differ between the two treatments. The glycemic profiles after soya ingestion were lower than those after cellulose ingestion. The area under the glucose curve and glucose peaks were significantly higher after cellulose ingestion (area under the curve 20.2 +/- 3.88 vs. 15.57 +/- 4.42 mM x min, P = .05; glucose peaks 4.97 +/- 0.76 vs. 3.77 +/- 0.77 mM, P less than 0.02). The xylose tests were in the normal range, indicating that there was no interference with exose absorption, and no statistical difference was found between cellulose and soya treatment. CONCLUSIONS: It is concluded that soya fiber compared with purified cellulose has a favorable effect on the rise of postprandial glycemia in type II diabetic patients; moreover, the use of soya fibers did not carry any untoward side effect.

[Evaluation of an impedance measurement method for determining body composition in diabetic subjects and normal controls]. / Validazione di una metodica di rilevazione impedenziometrica per la valutazione della composizione corporea in soggetti diabetici e controlli normali.

The reproducibility of impedance measurements made using the Human-IM system (Dietosystem, Milan-Italy) was assessed in a group of normal and diabetic subjects on the basis of three tests made under the same experimental conditions on three consecutive days. A total of 22 normal subjects, 29 insulin-dependent (IDD) and 6 noninsulin dependent (NIDD) diabetic patients were included in the study. The coefficient of variation between the three successive tests ranged between 0 and 2.7% (normals 1.1 +/- 0.7%, IDD 1.6 +/- 0.7%, NIDD 1.1 +/- 0.4%), thus confirming the good reproducibility of the method in all groups. There was no significant difference between impedance measurement tests in the two group of diabetic patients with regard to TBW, FAT and FFM. NIDD patients differed from normal subjects due to higher FAT levels, whereas there was no significant difference between IDD patients and normal subjects.

Effects of intraperitoneal versus subcutaneous insulin administration on lipoprotein metabolism in type I diabetes.

In order to compare the effects of intraperitoneal (IP) versus subcutaneous (SC) insulin delivery on plasma lipoproteins, lipoprotein cholesterol, triglycerides, and very-low-density lipoprotein (VLDL) metabolism were compared in five type I diabetic patients while they were receiving continuous IP insulin (CIPII) or continuous subcutaneous insulin infusion (CSII). Each therapy regimen was of at least 1 month duration, and patients were treated in random order. Mean daily plasma insulin was lower on CIPII compared with CSII. CIPII was associated with lower VLDL triglycerides and VLDL apolipoprotein (apo) B, and higher high-density lipoprotein (HDL) and HDL3 cholesterol. The decreased VLDL on CIPII appeared to be the result of both decreased production and increased clearance of VLDL apo B. The results suggest that the more physiologic route of insulin therapy (CIPII) is associated with lipoprotein profiles of lower atherogenic potential.

Defibrotide in extracorporeal circulation on healthy rabbits.

Defibrotide, a partially depolymerized DNA fraction obtained from mammalian lung, was found to have significant antithrombotic and fibrinolytic activities. On the basis of this evidence defibrotide could be of clinical value during hemoperfusive treatment. The present study was designed to evaluate the biological tolerance of this technique in a model of extracorporeal circulation, using an original Silastic apparatus, with defibrotide (0.83 mg/kg-1/min-1 after a 50 mg/kg-1 bolus injection) and heparin (0.66 IU/kg-1/min-1 after a 400 IU/kg-1 bolus injection) in ten rabbits (Group 1) and heparin only in ten others (Group 2, control group). In this study defibrotide produced a significantly lower pressure inside the circuit compared to the control group and gave a protective effect against those pathological changes which appeared during extracorporeal circulation and that may be considered omens of a state of shock. However the use of defibrotide in addition to heparin seemed to have a poor effect on platelet and leukocyte count alterations during application of this technique.

Glycerol-insulin raises circulating insulin antibodies in type I diabetic patients treated with permanently implanted devices.

The instability of insulin in the reservoirs of implantable insulin delivery devices has been a major obstacle in implementing this form of therapy. To overcome the problem of precipitation, a glycerol-insulin preparation has been used in large-scale long-term clinical trials. The aim of this study was to evaluate the stability of the glycerol-insulin solution and its effects on circulating insulin antibodies in eight type I diabetic patients who were implanted with an Infusaid pump (Infusaid Corporation, Norwood, MA) and followed for 1 year or more. Total insulin requirement did not change throughout the observation period. Plasma free insulin was higher during treatment with glycerol-insulin than with the standard insulin treatment (P less than .02). Insulin antibodies increased in all patients (P less than .05). High-performance liquid HPLC analysis of insulin samples from the pump reservoirs showed the generation of insulin modification products at a daily rate of 1.84%, reaching 40% to 50% of the total reservoir content 3 weeks after refilling; among these products, high molecular weight species accounted for about 15%. It is concluded that glycerol-insulin is not an adequate insulin preparation for use in implanted devices. Insulin deteriorated in the pump reservoirs, and insulin antibody concentration increased in the treated patients. It is believed that this antibody production is favored by circulating insulin fragments and polymers of insulin generated inside the pump reservoirs.