A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.

BACKGROUND: Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagon-like peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS: We conducted a 56-week, double-blind trial involving 3731 patients who did not have type 2 diabetes and who had a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension. We randomly assigned patients in a 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS: At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS: In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.).

[Maternal-fetal outcomes in women with gestational diabetes in an intensive control program]. / Desenlaces materno-fetales en mujeres con diabetes gestacional en un programa de control intensivo.

Background: Gestational diabetes mellitus (GDM) is first diagnosed during pregnancy and it is the most frequent maternal hyperglycemia. Objective: To know fetal and maternal outcomes in an intensive control program in pregnant women with and without DMG at the Instituto Mexicano del Seguro Social (Mexican Institute for Social Security) Regional General Hospital No. 6, in Ciudad Madero, Tamaulipas. Material and methods: A descriptive and retrospective study, which included 800 outcomes of pregnant women between January 2009 and June 2020. Anthropometric data and pregnancy outcomes were collected. The intensive control program consisted of face-to-face consultations of 1 to 4 weeks, granted according to the degree of metabolic control, with which it was given nutritional counseling, recommendations for physical activity, and in some cases pharmacological treatment. Results: The prevalence of GDM was 36.2%. There were no statistically significant differences between the two groups, except for respiratory distress syndrome, which was more common in GDM (9.4%, p = 0.06). Patients with GDM had a lower prevalence of macrosomy (6.1%) compared to the control group (6.6%). All women admitted to the program in the first trimester had fewer fetal and maternal complications. Conclusions: This study demonstrates the effectiveness and efficiency of implementing an intensive control program in women with GDM, by reducing and equalizing maternal and fetal outcomes compared to a group of women without the disease.

Introducción: la diabetes mellitus gestacional (DMG) se diagnóstica por primera vez en el embarazo y es la hiperglucemia materna más frecuente. Objetivo: conocer los desenlaces fetales y maternos en un programa de control intensivo en mujeres embarazadas con y sin DMG en el Hospital General Regional No. 6 del Instituto Mexicano del Seguro Social (IMSS) en Ciudad Madero, Tamaulipas. Material y métodos: estudio descriptivo y retrospectivo que incluyó 800 desenlaces de mujeres gestantes entre enero de 2009 y junio de 2020. Se recopilaron datos antropométricos y desenlaces del embarazo. El programa de control intensivo consistió en consultas presenciales de una a cuatro semanas, otorgadas según el grado de control metabólico, en las que se proporcionó consejería nutricional, recomendaciones de actividad física y en algunos casos tratamiento farmacológico. Resultados: la prevalencia de DMG fue de 36.2%. No hubo diferencias estadísticamente significativas en ambos grupos, a excepción del síndrome de distrés respiratorio, que fue más frecuente en DMG (9.4%, p = 0.06). Las pacientes con DMG tuvieron menor prevalencia de macrosomía (6.1%) a diferencia del grupo control (6.6%). Toda mujer ingresada al programa en el primer trimestre tuvo menores complicaciones fetales y maternas. Conclusiones: este estudio demuestra la eficacia y eficiencia de implementar un programa de control intensivo en mujeres con DMG, al reducir e igualar los desenlaces maternos y fetales en comparación con un grupo de mujeres sin la enfermedad.

Obesity and metabolic risks in children.

BACKGROUND: We undertook this study to establish the prevalence of overweight, obesity, abdominal obesity, high blood pressure, and high glucose and triglyceride levels in school-age children from Mexico City, as well as to determine how overweight and obesity are related to the other risk factors. METHODS: The study was a cross-sectional survey comprised of 1819 children (6-13 years of age) attending six elementary schools. Gender, age, weight, height, waist circumference, blood pressure, and levels of triglycerides and glucose were registered. Percentiles were calculated according to American standards for BMI, height, waist circumference, and blood pressure. RESULTS: Compared to American references, mean percentiles for waist circumference and BMI were >50, and mean height percentiles were <50. Prevalence of overweight was 22.3 and 23.6% for boys and girls, respectively; obesity, 28 and 21.2%; abdominal obesity, 22.1 and 11.7%; high triglyceride levels, 11.3 and 15.4%; high blood pressure, 4.8 and 5.8%, respectively. Overweight, obesity, and abdominal obesity are associated with higher blood pressure and triglyceride levels (odds ratio>1.0, p<0.05). Percentiles for BMI, waist circumference, systolic blood pressure, and diastolic blood pressure also had significant correlations (r>0.2, p<0.001). CONCLUSIONS: This population of Mexican school-age children was shorter and heavier than their American standards. The prevalence of metabolic risks was similar to those reported in American adolescents in NHANES surveys.

Use of sibutramine in obese Hispanic adolescents.

A study on the treatment of obese adolescents with the use of sibutramine in private practice is presented. Patients consisted of 24 boys and 43 girls with obesity (body mass index [BMI]>85th percentile sex-specific BMI for age and sex) ranging from 12 to 18 years of age. Patients were given sibutramine 10 mg per day for 6 months. With the last observation carried forward adjustment, after 6 months of treatment, patients' average weight changed from 91.6+/-19.7 kg to 81.9+/-19.0 kg (P<.001), that is, 89.5+/-7.3% of initial weight. The most frequently reported adverse events included increased blood pressure and pulse rate (n=7), constipation (n=8), dry mouth (n=4), and constipation and dry mouth (n=3). Sibutramine may be considered effective for the treatment of obese adolescents, with a level of safety similar to that observed in adult patients.

Impact of waist circumference reduction on cardiovascular risk in treated obese subjects.

BACKGROUND: The World Health Organization reports that waist circumference (WC) independent of weight or body mass index (BMI) predicts cardiovascular risk. We undertook this study to determine the change of prevalence in comorbidities associated with obesity and cardiovascular risk after favorably modifying WC. METHODS: We studied 153 nondiabetic patients with obesity (BMI =30 kg/m²) and WC in women =80 cm and in men =94 cm who entered a weight control program for 2 years. We evaluated the evolution of their anthropometric measurements and metabolic status. Ninety patients (58.8%) completed the study. With the prior acceptance of the patients, they received nutritional advice and psychological and physical activity support during their monthly visits. Also, anthropometric measurements and blood pressure were evaluated. At the beginning and after each 6 months, glucose, total cholesterol, HDL cholesterol and triglycerides were determined. At the beginning and at the end of study the Framingham risks were evaluated. RESULTS: Of the 90 patients, 37 (group 1) decreased their WC: in women <80 cm and in men <94 cm. In 53 patients (group 2) there were no significant changes. Changes were shown in group 1 for blood pressure (from 36.6% to 21.6%), hyperglycemia >100 mg/dl decreased from 18.8% to 8.1%, triglycerides >150 mg/dl decreased from 28.8% to 18.9% and Framingham risk at 10 years decreased. CONCLUSIONS: There is a direct relationship between WC and cardiovascular risk. When WC decreases, cardiovascular risk is favorably modified. Measurement of WC is a good predictor of cardiovascular risk.

Efficacy of glimepiride/metformin combination versus glibenclamide/metformin in patients with uncontrolled type 2 diabetes mellitus.

AIM: The aim of this study was to compare the efficacy of glimepiride/metformin combination versus glibenclamide/metformin for reaching glycemic control in patients with uncontrolled type 2 diabetes mellitus. PATIENTS AND METHODS: A randomized, double-blind, multicenter clinical trial was performed in 152 uncontrolled type 2 diabetic patients. Serum fasting and postprandial glucose, hemoglobin A1c (A1C), high-density lipoprotein cholesterol, and triglycerides were measured. After random allocation, all patients received two pills of glimepiride (1 mg)/metformin (500 mg) or glibenclamide (5 mg)/metformin (500 mg) po once a day. Dosage was increased to a maximum of four pills in order to reach the glycemic control goals (fasting glucose or=1% reduction). Statistical analyses were carried out using chi-square, ANOVA, or Student's t test. The protocol was approved by an ethics committee and met all requirements needed to perform research in human subjects; all patients gave written informed consent. RESULTS: Each study group included 76 patients. No significant differences in basal clinical and laboratory characteristics between groups were found. At the end of the study, A1C concentration was significantly lower in the glimepiride/metformin group (P=.025). A higher proportion of patients from the glimepiride group (44.6% vs. 26.8%, P<.05) reached the goal of A1C <7% at 12 months of treatment. A higher proportion of hypoglycemic events were observed in the glibenclamide group (28.9% vs. 17.1%, P<.047). CONCLUSION: Glimepiride/metformin demonstrated being more efficacious than glibenclamide/metformin at reaching the glycemic control goals with less hypoglycemic events in patients with uncontrolled type 2 diabetes mellitus.