Intragastric balloon: another option for treatment of obesity and morbid obesity.

BACKGROUND/AIMS: The BioEnterics Intragrastric Balloon (BIB, BioEnterics, Santa Barbara, CA) in association with restricted diet has been used for the treatment of obesity and morbid obesity. METHODOLOGY: Since March 1998, 349 BIB were placed in 303 obese and morbidly obese patients; 95 patients were male and 208 female; mean age was 41.5 years (19-70); mean weight was 118.8 Kg (67-229); mean BMI was 42 Kg/m2, % excess weight was 62.3% (4.6-216.3). The balloon was inserted and removed endoscopically under general anesthesia. Patients were given a balanced diet of 1000 Kcal/day. RESULTS: After 4 months of balloon treatment, the mean weight loss was 13.9 Kg and the mean reduction in BMI was 4.8 Kg/m2. weight loss was greater in male patients. weight loss was accompanied by an improvement of the diseases associated with obesity, in particular diabetes. CONCLUSIONS: The best indications for BIB were: morbidly obese (BMI >40) and super-obese patients (BMI >50) in preparation for bariatric operations; obese patients with BMI 35-40 with co-morbidity 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.

Ghrelin: a gut-brain hormone: effect of gastric bypass surgery.

BACKGROUND: Ghrelin is a newly recognized gastric hormone with orexigenic and adipogenic properties, produced primarily by the stomach. Ghrelin is reduced in obesity. weight loss is associated with an increase in fasting plasma ghrelin. We assessed the effect of massive weight loss on plasma ghrelin concentrations and its correlation with serum leptin levels and the presence of type 2 diabetes mellitus (DM) in severely obese patients. METHODS: A prospective study was conducted on 28 morbidly obese women (BMI 56.3 +/- 10.2 kg/m2) who underwent gastric bypass, divided into 2 groups: 14 non-diabetics (NGT) and 14 type 2 diabetics (DM2). Ghrelin and leptin were evaluated before silastic ring transected vertical gastric bypass, and again 12 months postoperatively. RESULTS: Fasting plasma ghrelin concentrations were 56% lower in NGT and 59% lower in DM2 compared with a lean control group (P < 0.001). There was no difference in ghrelin levels between NGT and DM2 groups before and after surgery (P > 0.05). Ghrelin was negatively correlated with leptin before gastric bypass surgery (r = 0.51, P < 0.01). The mean plasma ghrelin concentration decreased significantly after surgery in both groups (P < 0.001). CONCLUSION: Ghrelin was inversely related to leptin concentrations. Presence of diabetes did not affect the ghrelin pattern. Reduced production of ghrelin after gastric bypass could be partly responsible for the lack of hyperphagia and thus for the weight loss.

Weight change and the risk of gestational diabetes in obese women.

BACKGROUND: obesity is an established risk factor for gestational diabetes. It is not known whether this risk might be reduced through weight loss between pregnancies. We sought to determine whether weight loss between pregnancies reduced the risk of gestational diabetes among obese women. METHODS: We conducted a population-based cohort study of 4102 women with 2 or more singleton live births in Washington State between 1992 and 1998. All subjects were nondiabetic and obese (at least 200 lbs) at their first birth during these years. Weight change was calculated as the difference between prepregnancy weight for the 2 pregnancies. We estimated relative risks of gestational diabetes at the subsequent delivery through stratified analyses and Mantel-Haenszel estimates. RESULTS: Thirty-two percent of women lost weight between pregnancies, with a mean weight loss of 23 lbs. Women who lost at least 10 lbs between pregnancies had a decreased risk of gestational diabetes relative to women whose weight changed by less than 10 lbs (relative risk = 0.63; 95% confidence interval = 0.38-1.02, adjusted for age and weight gain during each pregnancy). Of the 61% of women who gained weight between pregnancies, the mean weight gain was 22 lbs. Women who gained at least 10 lbs had an increased risk of gestational diabetes (1.47; 1.05-2.04). CONCLUSIONS: Even moderate changes in prepregnancy weight can apparently affect the risk of gestational diabetes among obese women. This may offer further motivation for interventions aimed at reducing obesity among women of reproductive age.

Early mortality after radical radiotherapy for non-small-cell lung cancer: comparison of PET-staged and conventionally staged cohorts treated at a large tertiary referral center.

PURPOSE: At our center, approximately 30% of radical radiotherapy (RRT) candidates become ineligible for RRT for non-small-cell lung cancer (NSCLC) after positron emission tomography (PET). We hypothesized that early cancer death rates would be lower in patients receiving RRT after PET staging compared with conventionally staged patients. METHODS AND MATERIALS: Two prospective cohorts were compared. Cohort 1 consisted of all participants in an Australian randomized trial from our center given 60 Gy conventionally fractionated RRT with or without concurrent carboplatin from 1989 to 1995. Eligible patients had Stage I--III, Eastern Cooperative Oncology Group status 0 or 1, <10% weight loss, and had not undergone PET. Cohort 2 included all RRT candidates between November 1996 and April 1999 who received RRT after PET staging and fulfilled the above criteria for stage, Eastern Cooperative Oncology Group status, and weight loss. RESULTS: Eighty and 77 eligible patients comprised the PET and non-PET groups, respectively. The PET-selected patients had significantly less weight loss; 73% and 49% of the PET and non-PET patients, respectively, received chemotherapy. The median survival was 31 months for PET patients and 16 months for non-PET patients. Mortality from NSCLC and other causes in the first year was 17% and 8% for PET patients and 32% and 4% for non-PET patients, respectively. The hazard ratio for NSCLC mortality for PET vs. non-PET patients was 0.49 (p = 0.0016) on unifactorial analysis and was 0.55 (p = 0.0075) after adjusting for chemotherapy, which significantly improved survival. CONCLUSION: Patients selected for RRT after PET have lower early cancer mortality than those selected using conventional imaging.

Ephedrine is a sympathicomimetic agent that stimulates the central nervous and cardiovascular systems and causes bronchodilatation. It is one of the alkaloids in the herb Ephedra which is the basis of several over-the-counter herbal products, among which a number of popular weight-loss products. The Dutch Inspectorate for Health Care has received reports of adverse reactions presumably associated with Ephedra-containing weight-loss products. These adverse reactions comprised mainly palpitations, stress, headache and insomnia. The Ministry of Health in Canada has recently requested a market recall of some ephedrine-containing herbal products in response to a large number of adverse reactions reported in association with these products. The adverse reactions included stroke, heart attacks, cardiac arrhythmias, seizures and psychotic disorders. The voluntary recall concerns especially products that were marketed without approval and contain Ephedra in combination with caffeine or other stimulants. In the Netherlands, the status of Ephedra-containing products is currently reconsidered.

Effect of moderate weight loss on health-related quality of life: an analysis of combined data from 4 randomized trials of Sibutramine ( Meridia ) vs placebo.

OBJECTIVES: To determine whether (1) patients who experience greater weight loss also experience correspondingly greater improvements in health-related quality of life (HRQOL); (2) the improvement in HRQOL is noticeable for patients achieving moderate (5%-10%) weight reduction; and (3) the relationship between weight reduction and HRQOL is similar for patients receiving Sibutramine ( Meridia ) hydrochloride vs placebo. STUDY DESIGN: We combined data from 4 double-blind, randomized, controlled trials of administration of Sibutramine ( Meridia ) (20 mg/d) vs placebo. PATIENTS AND METHODS: Patients (n = 555) were mildly to moderately obese and had type 2 diabetes mellitus, dyslipidemia, or hypertension that was well controlled with an angiotensin-converting enzyme inhibitor or calcium channel blocker. The HRQOL was operationalized using the Impact of Weight on Quality of Life (IWQOL) and the Medical Outcomes Study 36-Question Short-Form (SF-36) instruments. The main statistical technique was a patient-level analysis of variance predicting change in HRQOL from study, treatment, and weight change. RESULTS: Moderate weight loss was associated with a statistically significant improvement in HRQOL for approximately half of the subscales evaluated (P < .05). The greatest sensitivity to change was shown by the SF-36 general health perception and change in health since last year subscales and the IWQOL overall health, mobility, and total subscales. Greater weight loss was associated with the most improvement in HRQOL. weight losses of 5.01% to 10.00% were associated with 2-unit changes in the SF-36 general health perception subscale and 10-unit changes in the IWQOL total subscale. Results were similar across study and treatment. CONCLUSIONS: Moderate weight loss is associated with noticeably improved HRQOL. Improvements in HRQOL are achievable by patients receiving Sibutramine ( Meridia ).

The effects of weight loss on renal function in patients with severe obesity.

Severe obesity is associated with increased renal plasma flow (RPF) and glomerular filtration rate (GFR). The aim of the present study was to examine whether weight loss may reverse glomerular dysfunction in obese subjects without overt renal disease. Renal glomerular function was studied in eight subjects with severe obesity (body mass index [BMI] 48.0 +/- 2.4) before and after weight loss. Nine healthy subjects served as controls. GFR and RPF were determined by measuring inulin and PAH clearance. In the obese group, GFR (145 +/- 14 ml/min) and RPF (803 +/- 39 ml/min) exceeded the control value by 61% (90 +/- 5 ml/min, P = 0.001) and 32% (610 +/- 41 ml/min, P < 0.005), respectively. Consequently, filtration fraction was increased. Mean arterial pressure, although normal, was higher than in the control group (101 +/- 4 versus 86 +/- 2 mmHg, P < 0.01). After weight loss, BMI decreased by 32 +/- 4%, to 32.1 +/- 1.5 (P = 0.001). GFR and RPF decreased to 110 +/- 7 ml/min (P = 0.01) and 698 +/- 42 ml/min (P < 0.02), respectively. Albumin excretion rate decreased from 16 microg/min (range, 4 to 152 microg/min) to 5 microg/min (range, 3 to 37 microg/min) (P < 0.01). Fractional clearance of albumin decreased from 3.2 x 10(-6) (range, 1.1 to 23 x 10(-6)) to 1.2 x 10(-6) (range, 0.5 to 6.8 x 10(-6)) (P < 0.02). This study shows that obesity-related glomerular hyperfiltration ameliorates after weight loss. The improvement in hyperfiltration may prevent the development of overt obesity-related glomerulopathy.

Effect of lean system 7 on metabolic rate and body composition.

OBJECTIVE: This study evaluated whether a commercial weight-loss product (Lean System 7) would result in less reduction in resting metabolic rate (RMR) in overweight subjects on a calorie-restricted diet and exercise regimen than in subjects using diet and exercise alone. METHODS: In this randomized, double-blind, placebo-controlled study, healthy overweight adults were given three capsules of a commercial weight-loss product twice daily or an identical placebo and followed a calorie-restricted diet and an exercise program for 8 wk. RMR, body weight, body mass index, waist and hip circumferences, and body composition by dual-energy x-ray absorptiometry were measured at baseline and week 8. An intention-to-treat analysis was performed. RESULTS: Of 47 adults enrolled, 35 completed the study. Subjects taking the commercial weight-loss product had a significant (P = 0.03) increase in RMR, 7.2% increase versus 0.7% decrease in the placebo group. Subjects taking the commercial weight-loss product also had a significant (P = 0.04) decrease in hip circumference, 3.78 cm versus 2.07 cm in the placebo group. There were no other statistically significant differences in any other outcome variable, diet composition, exercise compliance, or adverse events. CONCLUSION: The results of this study showed that administration of a commercial weight-loss product to overweight adults in conjunction with a calorie-restricted diet and moderate exercise program effectively reverses the decrease in RMR associated with calorie restriction within this study population. The commercial weight-loss product was well tolerated, and there were no serious adverse events over the 8 wk studied.