AzTrials
AzTrials

Type 2 DiabetesPhase 4GLP-1-CANNCT07558863

Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes

A Phase 4 study testing GLP-1 Receptor Agonists in people with Type 2 Diabetes and Diabetes With Diabetic Autonomic Neuropathy (Diagnosis), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
GLP-1 Receptor Agonists
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Apr 2026to 30 Aug 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

jianbo Li contact

13115008178

ljbzjlx18@aliyun.com

China1 site, 1 recruiting

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

    jianbo Li, Principal Investigator, 13115008178, ljbzjlx18@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
GLP-1 Receptor Agonists
Keywords
T2DM, DCAN, HRV, CART
Medical subject headings
Diabetes Mellitus, Type 2, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLP-1 Receptor AgonistsDrug

    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.

Study groups in NCT07558863
Study groupRoleWhat they receive
Control GroupNo interventionParticipants receive standard diabetes care (routine glucose-lowering treatment) without GLP-1 receptor agonist (GLP-1RA) intervention.
GLP-1 Receptor Agonist (GLP-1RA) GroupExperimentalParticipants 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.
Receives: Drug: GLP-1 Receptor Agonists

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and 12 weeks later]

Secondary outcomes (5)

  1. 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

    Measured: basline and 12 weeks later

  2. 30/15 ratio

    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

    Measured: basline and 12 weeks later

  3. 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

    Measured: basline and 12 weeks later

  4. 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

    Measured: basline and 12 weeks later

  5. 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

    Measured: basline and 12 weeks later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study start1 Apr 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07558863
Sponsor's protocol ID
2026-SR-026
Acronym
GLP-1-CAN
Status last verified
Apr 2026
First submitted
14 Apr 2026
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33804063

  • 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.

    PubMed 33292149

  • 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.

    PubMed 20460434

  • 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.

    PubMed 19259827

  • 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.

    PubMed 34793438

  • 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.

    PubMed 34317590

  • 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.

    PubMed 26254961

  • 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.

    PubMed 32497872

  • 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.

    PubMed 24567799

  • 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.

    PubMed 31552598

  • 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.

    PubMed 37021204

  • 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.

    PubMed 37397902

  • 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.

    PubMed 12716821

  • 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.

    PubMed 25685280

  • 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.

    PubMed 16014401

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GLP-1 Receptor Agonists in people with Type 2 Diabetes and Diabetes With Diabetic Autonomic Neuropathy (Diagnosis), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jianbo Li (13115008178, ljbzjlx18@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

heart rate variability（HRV） (time frame: baseline and 12 weeks later]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07558863, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in