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西布曲明在超重的成年西班牙裔2型糖尿病患者中的应用:一项为期12个月的随机、双盲、安慰剂对照临床试验。

Use of sibutramine in overweight adult hispanic patients with type 2 diabetes mellitus: a 12-month, randomized, double-blind, placebo-controlled clinical trial.

作者信息

Sánchez-Reyes Leticia, Fanghänel Guillermo, Yamamoto Jorge, Martínez-Rivas Lourdes, Campos-Franco Enrique, Berber Arturo

机构信息

Cardiovascular Risk Factor Unit, Cardiology Department, General Hospital of Mexico, Mexico.

出版信息

Clin Ther. 2004 Sep;26(9):1427-35. doi: 10.1016/j.clinthera.2004.09.017.

Abstract

BACKGROUND

The management of type 2 diabetes mellitus is complicated by the presence of risk factors related to overweight and obesity, particularly visceral adiposity. However, weight loss and weight maintenance are difficult for patients with diabetes, and the benefits of dietary modifications are typically modest. Sibutramine is a serotonin- and norepinephrine-reuptake inhibitor that reduces food intake by inducing early satiety and attenuates the decrease in basal energy expenditure associated with weight loss. Previous trials of sibutramine in overweight and obese patients with type 2 diabetes have shown significant weight loss accompanied by better glycemic control.

OBJECTIVE

The goal of this study was to assess the effect on body weight and glycemic control of sibutramine in combination with glibenclamide in obese Hispanic patients with type 2 diabetes.

METHODS

This was a 12-month, randomized, double-blind, placebo-controlled clinical trial conducted at the Endocrinology Service, General Hospital of Mexico, Mexico City. Included were overweight or obese (body mass index [BMI] >27 kg/M2) patients with type 2 diabetes between the ages of 24 and 65 years who had been receiving glibenclamide monotherapy for at least 2 weeks and whose glucose concentrations were stable. Patients were randomized to receive sibutramine 10 mg or placebo once daily. The primary efficacy measures were change in body weight, waist circumference, and glycosylated hemoglobin (HbA1c). Anthropometrics and fasting glucose concentrations were measured monthly. HbA1c was determined at baseline and at 6 and 12 months. Laboratory parameters were measured at baseline and at the end of the study.

RESULTS

Forty-four patients were randomized to receive sibutramine (28 women, 16 men; mean [SD] age, 47.6 [9.0] years), and 42 were randomized to receive placebo (31 women, 11 men; mean age, 45.8 [8.1] years). Twenty-four patients in the sibutramine group and 23 in the placebo group completed the trial. In the sibutramine group, body weight was reduced from a mean (SD) of 73.9 (10.3) kg at baseline to 69.8 (10.6) kg at month 12; BMI decreased from 29.9 (2.6) to 28.2 (2.9) kg/M2; waist circumference was reduced from 94.9 (8.4) to 90.8 (8.4) cm; the plasma fasting glucose concentration decreased from 140.4 (29.4) to 114.2 (32.0) mg/dL; and the HbA1c value was reduced from 8.9% (1.2) to 8.3% (1.2) (all, P < 0.001). In the placebo group, the corresponding changes were from 74.5 (10.3) kg at baseline to 73.1 (11.2) kg at month 12; from 30.1 (2.5) to 29.5 (2.9) kg/M2; from 94.4 (7.3) to 93.1 (8.3) cm (P < 0.05); from 140.7 (25.2) to 123.9 (38.3) mg/dL (P < 0.05); and from 9.0% (1.2) to 9.1% (1.3). In the sibutramine group, weight loss continued for up to 12 months.

CONCLUSION

In this population of obese Hispanic patients with type 2 diabetes, sibutramine combined with glibenclamide therapy achieved weight loss for up to 12 months and was associated with better glycemic control than placebo.

摘要

背景

2型糖尿病的管理因与超重和肥胖相关的危险因素而变得复杂,尤其是内脏脂肪过多。然而,糖尿病患者减肥和维持体重都很困难,饮食调整的益处通常不大。西布曲明是一种血清素和去甲肾上腺素再摄取抑制剂,它通过诱导早期饱腹感来减少食物摄入,并减轻与体重减轻相关的基础能量消耗的下降。先前针对超重和肥胖的2型糖尿病患者进行的西布曲明试验显示,体重显著减轻,同时血糖控制更佳。

目的

本研究的目的是评估西布曲明联合格列本脲对肥胖的西班牙裔2型糖尿病患者体重和血糖控制的影响。

方法

这是一项在墨西哥城墨西哥总医院内分泌科进行的为期12个月的随机、双盲、安慰剂对照临床试验。纳入的患者为年龄在24至65岁之间、超重或肥胖(体重指数[BMI]>27kg/m²)的2型糖尿病患者,这些患者接受格列本脲单药治疗至少2周且血糖浓度稳定。患者被随机分为每日一次接受10mg西布曲明或安慰剂。主要疗效指标为体重、腰围和糖化血红蛋白(HbA1c)的变化。每月测量人体测量指标和空腹血糖浓度。在基线、6个月和12个月时测定HbA1c。在基线和研究结束时测量实验室参数。

结果

44例患者被随机分配接受西布曲明治疗(28例女性,16例男性;平均[标准差]年龄,47.6[9.0]岁),42例患者被随机分配接受安慰剂治疗(31例女性,11例男性;平均年龄,45.8[8.1]岁)。西布曲明组24例患者和安慰剂组23例患者完成了试验。在西布曲明组,体重从基线时的平均(标准差)73.9(10.3)kg降至第12个月时的69.8(10.6)kg;BMI从29.9(2.6)降至28.2(2.9)kg/m²;腰围从94.9(8.4)降至90.8(8.4)cm;血浆空腹血糖浓度从140.4(29.4)降至114.2(32.0)mg/dL;HbA1c值从8.9%(1.2)降至8.3%(1.2)(所有P<0.001)。在安慰剂组,相应的变化分别为从基线时的74.5(10.3)kg至第12个月时的73.1(11.2)kg;从30.1(2.5)至29.5(2.9)kg/m²;从94.4(7.3)至93.1(8.3)cm(P<0.05);从140.7(25.2)至123.9(38.3)mg/dL(P<0.05);从9.0%(1.2)至9.1%(1.3)。在西布曲明组,体重减轻持续长达12个月。

结论

在这群肥胖的西班牙裔2型糖尿病患者中,西布曲明联合格列本脲治疗可实现长达12个月的体重减轻,且与比安慰剂更好的血糖控制相关。

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