The metabolic syndrome

OBJECTIVE —It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity. A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated. We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight, and thus the incidence of type 2 diabetes, in obese patients. RESEARCH DESIGN AND METHODS —In a 4-year, double-blind, prospective study, we randomized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo, three times daily. Participants had a BMI ≥30 kg/m 2 and normal (79%) or impaired (21%) glucose tolerance (IGT). Primary endpoints were time to onset of type 2 diabetes and change in body weight. Analyses were by intention to treat. RESULTS —Of orlistat-treated patients, 52% completed treatment compared with 34% of placebo recipients ( P P = 0.0032). Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT. Mean weight loss after 4 years was significantly greater with orlistat (5.8 vs. 3.0 kg with placebo; P P CONCLUSIONS —Compared with lifestyle changes alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinically representative obese population. Difference in diabetes incidence was detectable only in the IGT subgroup; weight loss was similar in subjects with IGT and or NGT.

/pdf/xenical-in-the-prevention-of-diabetes-in-obese-subjects-8fc2tliml6.pdf

XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients

The National Cholesterol Education Program’s Adult Treatment Panel III (ATP III) report [1] added the metabolic syndrome, a multidimensional risk factor for cardiovascular disease (CVD), as a coequal partner of elevated low-density lipoprotein (LDL) cholesterol for risk-reduction therapies. Interest in the metabolic syndrome has increased greatly since the publication of the ATP III report. There are several aspects to the metabolic syndrome that deserve consideration for clinical practice: 1) major clinical outcomes, 2) metabolic components, 3) pathogenesis, 4) clinical criteria for diagnosis, 5) risk for clinical outcomes, and 6) therapeutic interventions.

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(05)66378-7.pdf

The Metabolic Syndrome

Objective To assist health professionals who counsel patients with overweight and obesity, a systematic review was undertaken to determine types of weight-loss interventions that contribute to successful outcomes and to define expected weight-loss outcomes from such interventions. Design A search was conducted for weight-loss–focused randomized clinical trials with ≥1-year follow-up. Eighty studies were identified and are included in the evidence table. Outcomes measures The primary outcomes were a measure of weight loss at 6, 12, 24, 36, and 48 months. Eight types of weight-loss interventions—diet alone, diet and exercise, exercise alone, meal replacements, very-low-energy diets, weight-loss medications (orlistat and sibutramine), and advice alone—were identified. By using simple pooling across studies, subjects mean amount of weight loss at each time point for each intervention was determined. Statistical analyses performed Efficacy outcomes were calculated by meta-analysis and provide support for the pooled data. Hedges' gu was combined across studies to obtain an average effect size (and confidence level). Results A mean weight loss of 5 to 8.5 kg (5% to 9%) was observed during the first 6 months from interventions involving a reduced-energy diet and/or weight-loss medications with weight plateaus at approximately 6 months. In studies extending to 48 months, a mean 3 to 6 kg (3% to 6%) of weight loss was maintained with none of the groups experiencing weight regain to baseline. In contrast, advice-only and exercise-alone groups experienced minimal weight loss at any time point. Conclusions Weight-loss interventions utilizing a reduced-energy diet and exercise are associated with moderate weight loss at 6 months. Although there is some regain of weight, weight loss can be maintained. The addition of weight-loss medications somewhat enhances weight-loss maintenance.

Weight-loss Outcomes: A Systematic Review and Meta-Analysis of Weight-Loss Clinical Trials With a Minimum 1-year Follow-Up

Obesity is prevalent in the U.S. population and contributes significantly to morbidity and mortality. Treatments include behavioral therapy, pharmacotherapy, and bariatric surgery. Some sequelae of obesity are reversed with weight loss. Maintaining weight loss is a challenge.

https://www.nejm.org/doi/pdf/10.1056/NEJMra1514009

Mechanisms, Pathophysiology, and Management of Obesity

OBJECTIVE Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications. RESEARCH DESIGN AND METHODS In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28–40 kg/m 2 , and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured. RESULTS After 1 year of treatment, the orlistat group lost 6.2 ± 0.45% (mean ± SEM) of initial body weight vs. 4.3 ± 0.49% in the placebo group ( P P 1c ( P P P P P P P P CONCLUSIONS Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.

Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study

ContextOrlistat, a gastrointestinal lipase
inhibitor that reduces dietary fat absorption by approximately 30%,
may promote weight loss and reduce cardiovascular risk factors.ObjectiveTo test the hypothesis that orlistat combined with
dietary intervention is more effective than placebo plus diet for
weight loss and maintenance over 2 years.DesignRandomized, double-blind, placebo-controlled study
conducted from October 1992 to October 1995.Setting and ParticipantsObese adults (body mass index
[weight in kilograms divided by the square of height in meters],
30-43 kg/m2) evaluated at 18 US research centers.InterventionSubjects received placebo plus a controlled-energy
diet during a 4-week lead-in. On study day 1, the diet was continued
and subjects were randomized to receive placebo 3 times a day or
orlistat, 120 mg 3 times a day, for 52 weeks. After 52 weeks, subjects
began a weight-maintenance diet, and the placebo group
(n=133) continued to receive placebo and
orlistat-treated subjects were rerandomized to receive placebo 3 times
a day (n=138), orlistat, 60 mg (n=152)
or 120 mg (n=153) 3 times a day, for an additional 52
weeks.Main Outcome MeasuresBody weight change and changes in blood
pressure and serum lipid, glucose, and insulin levels.ResultsA total of 1187 subjects entered the protocol, and 892
were randomly assigned on day 1 to double-blind treatment. For
intent-to-treat analysis, 223 placebo-treated subjects and 657
orlistat-treated subjects were evaluated. During the first year
orlistat-treated subjects lost more weight (mean±SEM,
8.76±0.37 kg) than placebo-treated subjects
(5.81±0.67 kg) (P<.001). Subjects treated
with orlistat, 120 mg 3 times a day, during year 1 and year 2 regained
less weight during year 2 (3.2±0.45 kg; 35.2% regain)
than those who received orlistat, 60 mg (4.26±0.57 kg;
51.3% regain), or placebo (5.63±0.42 kg; 63.4%
regain) in year 2 (P<.001). Treatment with orlistat, 120 mg
3 times a day, was associated with improvements in fasting low-density
lipoprotein cholesterol and insulin levels.ConclusionsTwo-year treatment with orlistat plus diet
significantly promotes weight loss, lessens weight regain, and improves
some obesity-related disease risk factors.

https://jamanetwork.com/journals/jama/articlepdf/188381/joc80835.pdf

Weight Control and Risk Factor Reduction in Obese Subjects Treated for 2 Years With Orlistat: A Randomized Controlled Trial

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Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study

Weight Control and Risk Factor Reduction in Obese Subjects Treated for 2 Years With Orlistat: A Randomized Controlled Trial