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Recruiting NCT06461377

The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy

Phase IV Interventional Type 2 Diabetes Diabetes With Diabetic Autonomic Neuropathy (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glucagon-like peptide-1 receptor agonist：Semaglutide.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Diabetes With Diabetic Autonomic Neuropathy (Diagnosis). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Glucagon-like peptide-1 receptor agonist：Semaglutide
    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

Primary outcome measures

  • heart rate variability（HRV） [Time frame: baseline and 12 weeks later]
Secondary outcome measures (12)
  • E/I difference [Time frame: basline and 12 weeks later]
  • 30/15 ratio [Time frame: basline and 12 weeks later]
  • Valsalva action [Time frame: basline and 12 weeks later]
  • the difference between lying and Orthostatic blood pressure [Time frame: basline and 12 weeks later]
  • grip strength tests [Time frame: basline and 12 weeks later]
  • BMI [Time frame: basline and 12 weeks later]
  • FBG [Time frame: basline and 12 weeks later]
  • Fins [Time frame: basline and 12 weeks later]
  • Fc-peptide [Time frame: basline and 12 weeks later]
  • HOMA-IR [Time frame: basline and 12 weeks later]
  • HbA1c [Time frame: basline and 12 weeks later]
  • Total cholesterol [Time frame: basline and 12 weeks later]

Eligibility criteria

Inclusion criteria

  • Patients aged 18-70 years
  • Patients with T2DM who meet the diagnostic guidelines
  • The patient signed the relevant informed consent form
  • Being overweight or obese

Exclusion criteria

  • <18 years old
  • Pregnant or lactating women
  • Acute and chronic pancreatitis
  • Recent acute complications of diabetes
  • Arrhythmia or taking drugs that affect heart rate
  • Thyroid disease
  • Severe organ dysfunction
  • Denial of informed consen

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

  • 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. PMID 16014401
  • 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. PMID 25685280
  • 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. PMID 12716821
  • 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. PMID 37397902
  • 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. PMID 37021204
  • 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. PMID 31552598
  • 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. PMID 24567799
  • 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. PMID 32497872

Identifiers

NCT: NCT06461377 · 2023-SR-611

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗