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GLP-1-CAN

RecruitingPhase 4

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

A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Assets

GLP-1 / incretin class catch-all / Loxenatide / PEG-loxenatide / Semaglutide

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Diabetic neuropathy, Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥24

Primary endpoint

•Heart rate variability（HRV）

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07558863

Org study ID2026-SR-026

Timeline

Milestones

Study start2026-04-01actual

Study first posted2026-04-30actual

Last update posted2026-04-30actual

Primary completion2028-03-30estimated

Study completion2028-08-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Loxenatide / PEG-loxenatide Semaglutide

Study populations

Who this study enrolls

Diabetic neuropathyObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

3

Other clinical outcomes

2

Other (unclassified)

1

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint/low confidence

heart rate variability（HRV）

Time frame:baseline and 12 weeks later]

change from baseline, improvement

Secondary/protocol endpoint/low confidence

E/I difference

Time frame:basline and 12 weeks later

change from baseline, improvement

Secondary/protocol endpoint

the difference between lying and Orthostatic blood pressure

Time frame:basline and 12 weeks later

change from baseline, improvement

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Valsalva action

Time frame:basline and 12 weeks later

change from baseline, descriptive

Secondary/protocol endpoint

grip strength tests

Time frame:basline and 12 weeks later

change from baseline, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

30/15 ratio

Time frame:basline and 12 weeks later

change from baseline, descriptive

Publications (15)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Evaluating treatment options for cardiovascular autonomic neuropathy in patients with diabetes mellitus: a systematic review.
Diabetology international2023 Jul (month)PMID37397902doi:10.1007/s13340-023-00629-xvia CT.gov reference
Cardiac autonomic dysfunction and risk of incident stroke among adults with type 2 diabetes.
European stroke journal2023 Mar (month)PMID37021204doi:10.1177/23969873221127108via CT.gov reference
Identification of astroglia-like cardiac nexus glia that are critical regulators of cardiac development and function.
PLoS biology2021 Nov (month)PMID34793438doi:10.1371/journal.pbio.3001444via CT.gov reference
Anatomy and Physiology of Intrinsic Cardiac Autonomic Nervous System: Da Vinci Anatomy Card #2.
JACC. Case reports2021 Apr (month)PMID34317590doi:10.1016/j.jaccas.2021.02.018via CT.gov reference
Exendin-4 Promotes Schwann Cell Survival/Migration and Myelination In Vitro.
International journal of molecular sciences2021 Mar 15PMID33804063doi:10.3390/ijms22062971via CT.gov reference
Deciphering the Neuroprotective Role of Glucagon-like Peptide-1 Agonists in Diabetic Neuropathy: Current Perspective and Future Directions.
Current protein & peptide science2021 (year)PMID33292149doi:10.2174/1389203721999201208195901via CT.gov reference
Human adult cardiac autonomic innervation: Controversies in anatomical knowledge and relevance for cardiac neuromodulation.
Autonomic neuroscience : basic & clinical2020 Sep (month)PMID32497872doi:10.1016/j.autneu.2020.102674via CT.gov reference
Cardiac Autonomic Neuropathy in Obesity, the Metabolic Syndrome and Prediabetes: A Narrative Review.
Diabetes therapy : research, treatment and education of diabetes and related disorders2019 Dec (month)PMID31552598doi:10.1007/s13300-019-00693-0via CT.gov reference
Innervation of the heart: An invisible grid within a black box.
Trends in cardiovascular medicine2016 Apr (month)PMID26254961doi:10.1016/j.tcm.2015.07.001via CT.gov reference
Diabetes and cardiac autonomic neuropathy: Clinical manifestations, cardiovascular consequences, diagnosis and treatment.
World journal of diabetes2015 Feb 15PMID25685280doi:10.4239/wjd.v6.i1.80via CT.gov reference
Cardiac autonomic neuropathy in patients with diabetes mellitus.
World journal of diabetes2014 Feb 15PMID24567799doi:10.4239/wjd.v5.i1.17via CT.gov reference
Meteorin promotes the formation of GFAP-positive glia via activation of the Jak-STAT3 pathway.
Journal of cell science2010 Jun 1PMID20460434doi:10.1242/jcs.063784via CT.gov reference
Characterization of Meteorin--an evolutionary conserved neurotrophic factor.
Journal of molecular neuroscience : MN2009 Sep (month)PMID19259827doi:10.1007/s12031-009-9189-4via CT.gov reference
Cardiovascular autonomic neuropathy due to diabetes mellitus: clinical manifestations, consequences, and treatment.
The Journal of clinical endocrinology and metabolism2005 Oct (month)PMID16014401doi:10.1210/jc.2005-0754via CT.gov reference
Diabetic autonomic neuropathy.
Diabetes care2003 May (month)PMID12716821doi:10.2337/diacare.26.5.1553via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.