在马哈拉施特拉邦一项广受欢迎的生活方式改变活动中，与传统临床管理相比，两餐制饮食频率和运动对2型糖尿病患者糖化血红蛋白结果、体重及抗糖尿病药物的影响：马哈拉施特拉邦的一项准实验性多中心研究
Effect of Two-Only-Meal Frequency and Exercise on HbA1C Outcomes, Weight, and Anti-Diabetic Medication in Type 2 Diabetes in a Popular Lifestyle Change Campaign in Maharashtra, Compared to Conventional Clinical Management: A Quasi-Experimental Multicenter Study in Maharashtra.
作者信息
Ashtekar Shyam, Deshmukh Pradeep Pradeep, Ghaisas Nitin, Ashtekar Chandrashekhar, Upasani Sameeran, Kirloskar Madhuri, Kumthekar Ajit, Kelkar Mrunalini Bharat, Ashtekar Ratna, Misar Parag, Ratnaparakhe Vikas, Dhamangaonkar Manjiri, Kiwalkar Ravindra, Gandhi Sanjay, Powar Jagdish
机构信息
Department of Community Medicine, SMBT & IMSRC, Dhamangaon, Igatpuri, India.
Dean Research Faculty and HOD Community Medicine Department, All India Institute of Medical Sciences, Nagpur, India.
出版信息
Indian J Community Med. 2023 Jan-Feb;48(1):91-97. doi: 10.4103/ijcm.ijcm_248_22. Epub 2023 Feb 1.
BACKGROUND
Rising prevalence and poor outcomes make the twin challenges of diabetes epidemiology. This study evaluates effect of 2-only-daily-meals with exercise (2-OMEX) for its effect on HbA1c, oral hypoglycaemic agents (OHA) usage, body-weight among type-2-diabetes (T2DM) subjects, compared with conventional management.
MATERIAL AND METHODS
A quasi-experimental, multicentre study in 2-OMEX arm, and HbA1c by HPLC method. HbA1c and body-weight changes were analyzed by 'Difference in Difference' (DID) method. Meal frequency, exercise, energy intakes were based on recall. The required sample size was 20X2 for 1.1 difference in HbA1c with 95% CL and 80% power.
RESULTS
Socio-demographic and risk profile of analysed and omitted subjects were similar. Studied arms were also similar in baseline features. The results in 2-OMEX and conventional arm are: complete records analyzed 201 and 120. Mean (sd) values as follows: observation days 234 and 236, age 52.03(8.84) and 52.45(9.48) years (=0.6977), diabetes duration 4.6(3.05) and 4.9(2.97) years, BMI 27.28(5.27), 26.90(3.74) ( = 0.1859), baseline HbA1c gm% 7.46(1.52) and 7.55(1.58), end-line proportion of subjects attaining HbA1c ≤6.5gm% was 35.3% and 19.2% (=0.002), bodyweight loss 2.57% and 1.26%. OHA count 1.6 (1.23) and 2.7(1.06), (=0.0003). In 2-OMEX arm log-normal HbA1c declined significantly by 0.94 (95%CI: 1.60 to - 0.56, p=0.0333), weight loss difference 0.96 kg, and statistically not significant (=0.595). Two subjects in 2-OMEX arm showed partial remission. Mean baseline Kcal intakes in 2-OMEX arm, were 1200.4(F) and 1437.3(M) were significantly higher than conventional arm (F) and 1430 (M).
CONCLUSION
The 2-OMEX showed a sizeable and significant reduction in HbA1c and OHA use, in 7-months, with moderate intakes, compared to the conventional arm, possibly attributable to fewer insulin surges. More studies are required for its impact and pathways.
背景
糖尿病患病率不断上升且预后不佳，这构成了糖尿病流行病学的双重挑战。本研究评估了每日仅两餐并结合运动（2-OMEX）对2型糖尿病（T2DM）患者糖化血红蛋白（HbA1c）、口服降糖药（OHA）使用情况及体重的影响，并与传统治疗方法进行比较。
材料与方法
一项在2-OMEX组进行的准实验性多中心研究，采用高效液相色谱法检测HbA1c。采用“差异中的差异”（DID）方法分析HbA1c和体重变化。饮食频率、运动及能量摄入基于回忆。为使HbA1c差异达1.1，置信水平为95%，检验效能为80%，所需样本量为20×2。
结果
分析对象与未分析对象的社会人口统计学特征和风险状况相似。研究组的基线特征也相似。2-OMEX组和传统治疗组的结果如下：完整记录分析的分别为201例和120例。均值（标准差）如下：观察天数234天和236天，年龄52.03（8.84）岁和52.45（9.48）岁（P = 0.6977），糖尿病病程4.6（3.05）年和 4.9（2.97）年，体重指数27.28（5.27）、26.90（3.74）（P = 0.1859），基线HbA1c（克/百分比）7.46（1.52）和7.55（1.58），达到HbA1c≤6.5克/百分比的研究对象终末比例分别为35.3%和19.2%（P = 0.002），体重减轻2.57%和1.26%。OHA数量分别为1.6（1.23）和2.7（1.06）（P = 0.0003）。在2-OMEX组，对数正态分布的HbA1c显著下降0.94（95%置信区间：1.60至 - 0.56，P = 0.0333），体重减轻差异为0.96千克，差异无统计学意义（P = 0.595）。2-OMEX组有2名研究对象出现部分缓解。2-OMEX组女性和男性的平均基线千卡摄入量分别为1200.4和1437.3，显著高于传统治疗组女性的1430和男性的1430。
结论
与传统治疗组相比，2-OMEX在7个月内使HbA1c和OHA使用量显著大幅降低，摄入量适中，这可能归因于胰岛素分泌波动较少。其影响和作用途径还需要更多研究。
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