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Diabetic cardiac autonomic neuropathy (DCAN) is a common chronic complication that reduces survival in patients with diabetes. Epidemiological surveys have shown that the prevalence of DCAN is 25-75% in people with type 2 diabetes. The onset of DCAN is insidious and easy to be ignored in the early stage. With the progression of the disease, the following clinical symptoms gradually appear, including reduced heart rate variability, exercise intolerance, resting tachycardia, orthostatic hypotension, painless myocardial infarction and even sudden death, which seriously endanger the life and health of type 2 diabetes patients. Existing literature has shown that glucagon-like peptide-1 receptor agonist (GLP-1RA) can improve diabetic peripheral neuropathy and diabetic cognitive dysfunction, but there are few studies on improving diabetic autonomic neuropathy. Insulin resistance is an important risk factor for DCAN. Patients with type 2 diabetes are characterized by insulin resistance, and GLP-1RA is recognized as a drug to improve insulin resistance and control blood sugar in patients with diabetes. In this study, GLP-1RA was used to intervene patients with type 2 diabetes, and the changes in blood sugar control and insulin resistance status of patients were followed up. Special attention was paid to the improvement of autonomic neuropathy in diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | In the control group, no other intervention was used except the basic drugs for diabetes treatment | |
| GLP-1RA intervention group | Experimental | Subcutaneous injection of semaglutide 0.5-1mg （dosage depends on individual body weight）once a week (not off-label use)，lasting 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon-like peptide-1 receptor agonist：Semaglutide | Drug | The GLP-1RA intervention group was given subcutaneous injection of GLP-1RA for 3 months, while the control group was not given GLP-1RA intervention |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate variability（HRV） | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| E/I difference | Take an average of 6 deep breaths per minute, record the difference between the maximum heart rate and the minimum heart rate during deep breathing | basline and 12 weeks later |
| 30/15 ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jianbo Li, MD/PhD | Contact | 13951750648 | ljbzjlx18@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| jianbo Li, MD/PhD | First Affiliated Hospital，Nanjing Medical University，China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16014401 | Background | 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. | |
| 25685280 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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The heart rate in lying position was measured, and the R-R interval in more than 30 beats was measured after standing, and the ratio between the longest R-R interval in the 25-35 beats and the shortest R-R interval in the 10-15 beats after standing was calculated
| basline and 12 weeks later |
| Valsalva action | After deep inhalation, hold your breath as much as possible, and then blow air into the modified sphygmomanometer to keep the pressure of the sphygmomanometer at 40mmHg, continue for 10-15s, and then relax for 1 minute, a total of 3 minutes. At the same time, ECG was recorded to record the ratio of maximum heart rate to minimum heart rate | basline and 12 weeks later |
| the difference between lying and Orthostatic blood pressure | Blood pressure was measured in the supine position. The patient was asked to stand immediately, and blood pressure was measured at the first and fifth minutes | basline and 12 weeks later |
| grip strength tests | First, the basic blood pressure and the maximum grip strength were measured, and the blood pressure was measured after 5 minutes of continuous hard clenching with the grip apparatus (the force used was 30% of the maximum grip strength measured), and the blood pressure difference was calculated | basline and 12 weeks later |
| BMI | It is calculated by dividing a person's weight in kg by their height in meters squared | basline and 12 weeks later |
| FBG | Fasting glucose | basline and 12 weeks later |
| Fins | Fasting insulin | basline and 12 weeks later |
| Fc-peptide | Fasting c-peptide | basline and 12 weeks later |
| HOMA-IR | calculated by HOMA Calculator v2.2.3 | basline and 12 weeks later |
| HbA1c | Reflect the average blood sugar of 3 months | basline and 12 weeks later |
| Total cholesterol | one of serum biochemical index | basline and 12 weeks later |
| triglyceride | one of serum biochemical index | basline and 12 weeks later |
| HDL | high-density lipoprotein，one of serum biochemical index | basline and 12 weeks later |
| LDL | low density lipoprotein，one of serum biochemical index | basline and 12 weeks later |
| UA | Uric Acid，one of serum biochemical index | basline and 12 weeks later |
| creatinine | one of serum biochemical index | basline and 12 weeks later |
| eGFR | Estimated glomerular filtration rate，one of serum biochemical index | basline and 12 weeks later |
| Urinary trace albumin/urinary creatinine | urine protein test urine protein urine protein test | basline and 12 weeks later |
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| 37397902 | Background | 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. |
| 37021204 | Background | 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. |
| 31552598 | Background | 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. |
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| 32497872 | Background | 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. |
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| 34317590 | Background | 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. |
| 34793438 | Background | 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. |
| 19259827 | Background | 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. |
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| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |