Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes (GLP-1-CAN)
A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus
This study aims to investigate whether a class of diabetes medications called GLP-1 receptor agonists (GLP-1RA), specifically semaglutide or polyethylene glycol loxenatide, can improve heart-related nerve damage in people with type 2 diabetes. This heart-related nerve damage is known as diabetic cardiac autonomic neuropathy (DCAN), which can cause problems such as fast resting heart rate, low blood pressure upon standing, and in severe cases, heart attack or sudden death.
In this study, 60 adults with type 2 diabetes (ages 18-80) will be randomly divided into two groups. One group will receive standard diabetes care only, while the other group will receive standard care plus a once-weekly injection of either semaglutide or polyethylene glycol loxenatide for 6 months. Participants will undergo tests before and after the treatment period, including blood tests and non-invasive heart function tests (24-hour heart rate variability monitoring and cardiac autonomic reflex tests).
The main goal is to see whether GLP-1RA treatment improves heart rate variability, a key sign of heart nerve function. The study also looks at changes in body weight, blood sugar control, and insulin resistance. This research may help determine whether GLP-1RA medications can protect against or improve diabetic heart nerve damage, beyond their known benefits for blood sugar control.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：jianbo Li
- 电话号码：13115008178
- 邮箱：ljbzjlx18@aliyun.com
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 招聘中
- The First Affiliated Hospital of Nanjing Medical University
-
接触：
- jianbo Li, Principal Investigator
- 电话号码：13115008178
- 邮箱：ljbzjlx18@aliyun.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients aged 18-70 years
- Patients with type 2 diabetes mellitus (T2DM) who meet the diagnostic guidelines
- Patient has signed the relevant informed consent form
- Being overweight or obese (BMI ≥ 24 kg/m²)
Exclusion Criteria:
- Age < 18 years
- Pregnant or lactating women
- Acute or chronic pancreatitis
- Recent acute complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state)
- Arrhythmia or taking medications that affect heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs)
- Thyroid disease
- Severe organ dysfunction (e.g., heart, liver, kidney failure)
- Denial of informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control Group
Participants receive standard diabetes care (routine glucose-lowering treatment) without GLP-1 receptor agonist (GLP-1RA) intervention.
|
|
|
实验性的：GLP-1 Receptor Agonist (GLP-1RA) Group
Participants receive standard diabetes care plus a once-weekly subcutaneous injection of a GLP-1 receptor agonist (either semaglutide or polyethylene glycol loxenatide) for 6 months.
Semaglutide is administered at 0.5 mg once weekly; polyethylene glycol loxenatide is administered at 0.2 mg once weekly.
Both are used within approved labeling for type 2 diabetes.
|
GLP-1 receptor agonists are administered as a once-weekly subcutaneous injection for 6 months.
Two specific GLP-1RAs are used in this study: semaglutide at 0.5 mg once weekly, or polyethylene glycol loxenatide at 0.2 mg once weekly.
Both are approved for the treatment of type 2 diabetes and are used within their approved dosing guidelines.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
heart rate variability（HRV）
大体时间：baseline and 12 weeks later]
|
All participants were given ambulatory electrocardiogram.The time domain analysis and frequency domain analysis of heart rate variability are included in the holter ECG report.
|
baseline and 12 weeks later]
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
E/I 差异
大体时间：基线和 12 周后
|
平均每分钟深呼吸6次，记录深呼吸时最大心率与最小心率的差值
|
基线和 12 周后
|
|
30/15 比例
大体时间：基线和 12 周后
|
测量卧位心率，站立后测量30次以上R-R间期，以及站立后25-35次最长R-R间期与10-15次最短R-R间期的比值被计算了
|
基线和 12 周后
|
|
瓦氏动作
大体时间：基线和 12 周后
|
深吸气后，尽量屏住呼吸，然后向改良血压计内吹气，使血压计压力保持在40mmHg，持续10-15s，然后放松1分钟，共3分钟。
同时记录心电图，记录最大心率与最小心率的比值
|
基线和 12 周后
|
|
卧位血压和立位血压的区别
大体时间：基线和 12 周后
|
在仰卧位测量血压。
让患者立即站立，第1分钟和第5分钟测量血压
|
基线和 12 周后
|
|
握力测试
大体时间：基线和 12 周后
|
首先测量基础血压和最大握力，用握力器连续用力握紧5分钟后测量血压（所用力为测得最大握力的30%），测量血压计算差值
|
基线和 12 周后
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Takaku S, Tsukamoto M, Niimi N, Yako H, Sango K. Exendin-4 Promotes Schwann Cell Survival/Migration and Myelination In Vitro. Int J Mol Sci. 2021 Mar 15;22(6):2971. doi: 10.3390/ijms22062971.
- Mehta K, Behl T, Kumar A, Uddin MS, Zengin G, Arora S. Deciphering the Neuroprotective Role of Glucagon-like Peptide-1 Agonists in Diabetic Neuropathy: Current Perspective and Future Directions. Curr Protein Pept Sci. 2021;22(1):4-18. doi: 10.2174/1389203721999201208195901.
- Lee HS, Han J, Lee SH, Park JA, Kim KW. Meteorin promotes the formation of GFAP-positive glia via activation of the Jak-STAT3 pathway. J Cell Sci. 2010 Jun 1;123(Pt 11):1959-68. doi: 10.1242/jcs.063784. Epub 2010 May 11.
- Jorgensen JR, Thompson L, Fjord-Larsen L, Krabbe C, Torp M, Kalkkinen N, Hansen C, Wahlberg L. Characterization of Meteorin--an evolutionary conserved neurotrophic factor. J Mol Neurosci. 2009 Sep;39(1-2):104-16. doi: 10.1007/s12031-009-9189-4. Epub 2009 Mar 4.
- Kikel-Coury NL, Brandt JP, Correia IA, O'Dea MR, DeSantis DF, Sterling F, Vaughan K, Ozcebe G, Zorlutuna P, Smith CJ. Identification of astroglia-like cardiac nexus glia that are critical regulators of cardiac development and function. PLoS Biol. 2021 Nov 18;19(11):e3001444. doi: 10.1371/journal.pbio.3001444. eCollection 2021 Nov.
- Aksu T, Gupta D, Pauza DH. Anatomy and Physiology of Intrinsic Cardiac Autonomic Nervous System: Da Vinci Anatomy Card #2. JACC Case Rep. 2021 Apr 21;3(4):625-629. doi: 10.1016/j.jaccas.2021.02.018. eCollection 2021 Apr.
- Kapa S, DeSimone CV, Asirvatham SJ. Innervation of the heart: An invisible grid within a black box. Trends Cardiovasc Med. 2016 Apr;26(3):245-57. doi: 10.1016/j.tcm.2015.07.001. Epub 2015 Jul 9.
- Wink J, van Delft R, Notenboom RGE, Wouters PF, DeRuiter MC, Plevier JWM, Jongbloed MRM. Human adult cardiac autonomic innervation: Controversies in anatomical knowledge and relevance for cardiac neuromodulation. Auton Neurosci. 2020 Sep;227:102674. doi: 10.1016/j.autneu.2020.102674. Epub 2020 May 16.
- Dimitropoulos G, Tahrani AA, Stevens MJ. Cardiac autonomic neuropathy in patients with diabetes mellitus. World J Diabetes. 2014 Feb 15;5(1):17-39. doi: 10.4239/wjd.v5.i1.17.
- Williams SM, Eleftheriadou A, Alam U, Cuthbertson DJ, Wilding JPH. Cardiac Autonomic Neuropathy in Obesity, the Metabolic Syndrome and Prediabetes: A Narrative Review. Diabetes Ther. 2019 Dec;10(6):1995-2021. doi: 10.1007/s13300-019-00693-0. Epub 2019 Sep 24.
- Kaze AD, Yuyun MF, Fonarow GC, Echouffo-Tcheugui JB. Cardiac autonomic dysfunction and risk of incident stroke among adults with type 2 diabetes. Eur Stroke J. 2023 Mar;8(1):275-282. doi: 10.1177/23969873221127108. Epub 2022 Nov 1.
- Goh JK, Koh L. Evaluating treatment options for cardiovascular autonomic neuropathy in patients with diabetes mellitus: a systematic review. Diabetol Int. 2023 Apr 25;14(3):224-242. doi: 10.1007/s13340-023-00629-x. eCollection 2023 Jul.
- Vinik AI, Maser RE, Mitchell BD, Freeman R. Diabetic autonomic neuropathy. Diabetes Care. 2003 May;26(5):1553-79. doi: 10.2337/diacare.26.5.1553.
- Balcioglu AS, Muderrisoglu H. Diabetes and cardiac autonomic neuropathy: Clinical manifestations, cardiovascular consequences, diagnosis and treatment. World J Diabetes. 2015 Feb 15;6(1):80-91. doi: 10.4239/wjd.v6.i1.80.
- Maser RE, Lenhard MJ. Cardiovascular autonomic neuropathy due to diabetes mellitus: clinical manifestations, consequences, and treatment. J Clin Endocrinol Metab. 2005 Oct;90(10):5896-903. doi: 10.1210/jc.2005-0754. Epub 2005 Jul 12.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月1日
初级完成 (估计的)
2028年3月30日
研究完成 (估计的)
2028年8月30日
研究注册日期
首次提交
2026年4月14日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月27日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.