将 Curalin 补充剂作为 2 型糖尿病的附加疗法。

IF 6.1 3区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes research and clinical practice Pub Date : 2024-11-06 DOI:10.1016/j.diabres.2024.111912

Itamar Raz , Roni Weinberg Sibony , Saar Dor , Aliza Rozenberg , Ilan Yanuv , Ofer Yigdal , Ron Elul , Omri Segev

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引用次数: 0

摘要

目的：研究 Curalin 作为抗糖尿病药物 (ADD) 补充剂的有效性和安全性。其中，109 名年龄在 18-85 岁之间、HA1c 为 7.5-10 %、正在接受 ADD 治疗的患者按 1:1 随机分配接受 Curalin 补充剂或安慰剂。主要疗效终点是 3 个月后 HbA1c 的变化。次要终点是 HbA1c 下降 0.5 % 以上和 1 % 以上。探索性终点包括糖尿病治疗满意度问卷（DTSQ）、临床和实验室结果：3 个月后，Curalin 组的 HbA1c 平均降低了 1.30 %（SD = 0.79），而安慰剂组的 HbA1c 平均降低了 0.10 %（SD = 0.70）（P 结论：Curalin 治疗显著降低了 HbA1c：库拉林治疗可在 3 个月内明显降低 HbA1c，且耐受性良好。

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Curalin supplement as add-on therapy for type 2 diabetes Mellitus

Aims

To examine the efficacy and safety of Curalin, as a supplement to anti-diabetic drugs (ADD).

Methods

135 patients were enrolled in the study. Among them, 109, ages 18–85 years, with HA1c 7.5–10 % under treatment with ADD were randomized 1:1 to receive Curalin supplement or placebo. The primary efficacy endpoint was the change in HbA1c after 3 months. The secondary endpoint was a decrease in HbA1c by more than 0.5 % and by more than 1 %. The exploratory endpoints included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), clinical and laboratory results.

Results

After 3 months, the mean reduction in HbA1c was 1.30 % (SD = 0.79) in the Curalin group compared to 0.10 % (SD = 0.70) in the placebo group (P < 0.0001). A decrease in HbA1c of ≥ 0.5 % was observed in 90.0 % of Curalin patients versus 19.0 % of placebo patients (P < 0.0001). HbA1c reduction of ≥ 1 % occurred in 64.0 % of Curalin patients and 11.9 % of placebo patients (P < 0.0001). Curalin patients reported higher satisfaction (DTSQ) with no severe adverse events.

Conclusions

Curalin treatment significantly reduced HbA1c over a period of 3 months and was well-tolerated.

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来源期刊

Diabetes research and clinical practice 医学-内分泌学与代谢

CiteScore

10.30

自引率

3.90%

发文量

862

审稿时长

32 days

期刊介绍： Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.