Abstract
This study aimed to evaluate the influence of Jinlida granules on glycemic variability with or without metformin treatment in patients with newly diagnosed type 2 diabetes. This study was a 16-week, double-blinded, randomized, controlled clinical trial. The enrolled patients with newly diagnosed type 2 diabetes were randomly divided into four groups: control, Jinlida, metformin, and combination treatment groups. A retrospective continuous glucose monitoring (CGM) system was used for subcutaneous interstitial glucose monitoring for 3 days consecutively. Hemoglobin A1c (HbA1c), traditional Chinese medicine symptom score, and CGM parameters, including glucose coefficient of variation, standard deviation of blood glucose values, and time in range of glucose 3.9–10.0 mmol/L, were assessed pre-test and post-test. A total of 138 participants completed the entire procedure. Compared with the pre-test, fasting plasma glucose, 2 hour postprandial plasma glucose, HbA1c, and traditional Chinese medicine symptom score all decreased in the four groups at the end of the test, and the combination treatment group showed the most significant decrease. In terms of CGM parameters, time in range of the Jinlida and metformin groups improved after intervention compared with the baseline (Jinlida group: 78.68 ± 26.15 versus 55.47 ± 33.29; metformin group: 87.29 ± 12.21 vs. 75.44 ± 25.42; P < 0.01). Additionally, only the Jinlida group showed decreased glucose standard deviation after intervention (1.57 ± 0.61 vs. 1.96 ± 0.95; P < 0.01). Jinlida granules can improve glycemic control and glycemic variability in patients with newly diagnosed type 2 diabetes. Clinical trial registration number: ChiCTR-IOR-16009296.
Highlights
The national incidence of type 2 diabetes (T2D) in China is increasing annually
This study aimed to evaluate the influence of Jinlida granules on glycemic variability with or without metformin treatment in newly diagnosed T2D patients
There were no significant differences in the clinical parameters, including BMI, blood pressure, lipid profile, metrics of glucose level (FPG, 2h-PG, and Hemoglobin A1c (HbA1c)), and Traditional Chinese medicine (TCM) symptom score
Summary
The national incidence of type 2 diabetes (T2D) in China is increasing annually. The estimated overall prevalence of diabetes is 10.9% among adults in China [1]. Traditional Chinese medicine (TCM) therapy for T2D has been widely used in China. TCM can provide additional benefits to patients with T2D, such as ameliorating glycemic control, improving insulin resistance and pancreatic islet function, inducing weight loss, and low incidence of adverse events [2,3,4,5]. Pharmacological studies have demonstrated that TCM can rehabilitate islet β-cell impairment, stimulate insulin secretion, and strengthen the utilization of glucose in peripheral tissues [6]. In the Standards of Medical Care for Type 2 Diabetes in China 2019, a section on diabetes and Chinese herbal medicine was first highlighted [7]
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