Multicenter, Double Blind, Randomized, Controlled Study on Metabolic Formula Combined with Metformin Intervening Type 2 Diabetes Patients with Obesity

doi:10.12114/j.issn.1007-9572.2023.0789

Abstract

Abstract:

Background

Obesity is an important risk factor for type 2 diabetes mellitus (T2DM), which can further aggravate insulin resistance and increase the difficulty of glycemic management. Current glucose-lowering therapies have certain limitations in improving body weight and metabolic disorders. Traditional Chinese medicine (TCM), characterized by multi-target metabolic regulation, may provide potential advantages in the comprehensive management of patients with T2DM complicated by obesity; however, high-quality randomized controlled clinical evidence remains limited.

Objective

To investigate the effects of Metabolic Formula combined with metformin on body weight, glucose and lipid metabolism-related indicators, and TCM syndrome scores in patients with T2DM complicated by obesity, and to evaluate its safety.

Methods

This was a randomized, double-blind, placebo-controlled clinical trial. A total of 266 patients with T2DM complicated by obesity who visited the Longhua Hospital Shanghai University of Traditional Chinese Medicine from May 2021 to November 2022 were enrolled and randomly assigned using a random number table to the Metabolic Formula group and the control group at a 1∶1 ratio, with 133 patients in each group. Both groups received metformin treatment and lifestyle management. The Metabolic Formula group received additional Metabolic Formula granules, whereas the control group received placebo granules. The intervention lasted for 12 weeks. Changes in body weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, fasting blood glucose (FBG), 2-hour postprandial glucose (2 hPG), glycated hemoglobin (HbA_1c), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), lipid profiles, and TCM syndrome scores were compared between the two groups before and after treatment. Adverse events were also recorded.

Results

A total of 126 patients in the Metabolic Formula group and 123 patients in the control group completed the 12-week intervention. No significant differences were observed in baseline characteristics or outcome measures between the two groups before treatment (P>0.05). After treatment, compared with the control group, patients in the Metabolic Formula group showed significantly greater improvements in body weight, BMI, FBG, 2 hPG, HbA_1c, FINS, HOMA-IR, and TCM syndrome scores (P<0.05). No serious adverse events occurred in either group during the treatment period.

Conclusion

Metabolic Formula combined with metformin can further improve glucose and lipid metabolic abnormalities, reduce body weight, and improve TCM syndrome scores in patients with T2DM complicated by obesity. This therapeutic strategy demonstrates favorable clinical value and safety.

Key words: Diabetes mellitus, type 2, Obesity, Metabolic formula, Metformin, Traditional Chinese medicine, Randomized controlled trial

摘要：

背景

肥胖是2型糖尿病（T2DM）的重要危险因素，可进一步加重胰岛素抵抗，增加血糖管理难度。现有降糖治疗方案在改善体质量及代谢异常方面存在一定局限。中医药具有多靶点调节代谢的特点，在T2DM合并肥胖患者综合管理中具有潜在优势，但相关高质量随机对照研究证据仍较有限。

目的

探讨代谢方联合二甲双胍治疗T2DM合并肥胖患者对体质量、糖脂代谢指标及中医证候积分的影响，并评价其安全性。

方法

本研究为随机、双盲、安慰剂对照临床试验。选取2021年5月—2022年11月于上海中医药大学附属龙华医院中医内科门诊就诊的T2DM合并肥胖患者266例，采用随机数字表法按1∶1比例分为代谢方组和对照组，每组各133例。两组患者均给予二甲双胍治疗及健康管理，代谢方组加用代谢方颗粒，对照组加用安慰剂颗粒，连续干预12周。比较两组患者治疗前后体质量、BMI、腰围、臀围、腰臀比、空腹血糖、餐后2 h血糖、糖化血红蛋白（HbA_1c）、空腹胰岛素、胰岛素抵抗指数、血脂指标及中医证候积分变化，并记录不良事件。

结果

最终代谢方组126例、对照组123例完成12周干预。治疗前，两组患者一般资料及各观察指标比较，差异均无统计学意义（P>0.05）。治疗后，与对照组比较，代谢方组体质量、BMI、空腹血糖、餐后2 h血糖、HbA_1c、空腹胰岛素、胰岛素抵抗指数及中医证候积分改善程度更明显，差异有统计学意义（P<0.05）。两组患者治疗期间均未发生严重不良事件。

结论

代谢方联合二甲双胍可以调控T2DM合并肥胖患者糖脂代谢异常，降低体质量及改善中医证候评分，具有较好的临床应用价值和安全性。

关键词: 糖尿病，2型, 肥胖, 代谢方, 二甲双胍, 中医药学, 临床研究

HU Ruomeng,LIU Zhidong,CHEN Junlan, et al. Multicenter, Double Blind, Randomized, Controlled Study on Metabolic Formula Combined with Metformin Intervening Type 2 Diabetes Patients with Obesity[J]. Chinese General Practice, 2026, 29(33): 4854-4860. DOI: 10.12114/j.issn.1007-9572.2023.0789.
胡若萌,刘志栋,陈俊岚等. 代谢方联合二甲双胍干预2型糖尿病合并肥胖患者的多中心、双盲随机对照研究[J]. 中国全科医学, 2026, 29(33): 4854-4860. DOI: 10.12114/j.issn.1007-9572.2023.0789.

Figures/Tables 8

References 34

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组别	例数	年龄（±s，岁）	性别[例（%）]		身高[M（P₂₅，P₇₅），cm]	体质量[M（P₂₅，P₇₅），kg]
组别	例数	年龄（±s，岁）	男	女	身高[M（P₂₅，P₇₅），cm]	体质量[M（P₂₅，P₇₅），kg]
对照组	123	53.08±13.64	68（55.3）	55（44.7）	172.0（164.2，175.6）	85.60（78.10，91.40）
代谢方组	126	53.12±12.17	77（61.1）	49（38.9）	174.0（165.7，177.7）	87.80（81.15，91.85）
检验统计量值		-0.023^a	0.646^b		6 641	6 726
P值		0.982	0.422		0.051	0.072

组别	例数	年龄（±s，岁）	性别[例（%）]		身高[M（P₂₅，P₇₅），cm]	体质量[M（P₂₅，P₇₅），kg]
组别	例数	年龄（±s，岁）	男	女	身高[M（P₂₅，P₇₅），cm]	体质量[M（P₂₅，P₇₅），kg]
对照组	123	53.08±13.64	68（55.3）	55（44.7）	172.0（164.2，175.6）	85.60（78.10，91.40）
代谢方组	126	53.12±12.17	77（61.1）	49（38.9）	174.0（165.7，177.7）	87.80（81.15，91.85）
检验统计量值		-0.023^a	0.646^b		6 641	6 726
P值		0.982	0.422		0.051	0.072

组别	例数	腰围（cm）		臀围（cm）		WHR
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	123	104.58±9.82	103.39±9.81^a	108.31±9.29	107.72±9.28	0.97±0.05	0.96±0.05^a
代谢方组	126	104.23±10.85	101.99±10.89^a	108.46±10.93	107.34±10.96	0.96±0.08	0.95±0.08^a
t值		0.261	1.069	-0.118	0.295	0.207	0.802
P值		0.794	0.286	0.906	0.769	0.836	0.423

组别	例数	腰围（cm）		臀围（cm）		WHR
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
对照组	123	104.58±9.82	103.39±9.81^a	108.31±9.29	107.72±9.28	0.97±0.05	0.96±0.05^a
代谢方组	126	104.23±10.85	101.99±10.89^a	108.46±10.93	107.34±10.96	0.96±0.08	0.95±0.08^a
t值		0.261	1.069	-0.118	0.295	0.207	0.802
P值		0.794	0.286	0.906	0.769	0.836	0.423

组别	例数	体质量（±s，kg）		BMI（kg/m²）		体质量降低值（±s，kg）
组别	例数	治疗前	治疗后	治疗前（±s）	治疗后[M（P₂₅，P₇₅）]	体质量降低值（±s，kg）
对照组	123	84.30±8.34	82.82±8.33	29.23±0.61	28.70（28.33，29.04）	1.48±0.29
代谢方组	126	86.18±8.09	83.37±8.05	29.24±0.57	28.25（27.85，28.67）	2.81±0.38
t（u）值		-1.806	-0.535	1.529	10 779^a	-31.100
P值		0.072	0.593	0.126	<0.001	<0.001