GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06461377

RecruitingPhase 4

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

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Diabetic neuropathy, Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

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 IDNCT06461377

Org study ID2023-SR-611

Timeline

Milestones

Study start2024-06-13actual

Study first posted2024-06-17actual

Last update posted2024-06-21actual

Primary completion2026-12-31estimated

Study completion2027-12-31estimated

Assets

Investigational agents

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

1. Patients aged 18-70 years

2. Patients with T2DM who meet the diagnostic guidelines

3. The patient signed the relevant informed consent form

4. Being overweight or obese

Exclusion criteria

1. <18 years old

2. Pregnant or lactating women

3. Acute and chronic pancreatitis

4. Recent acute complications of diabetes

5. Arrhythmia or taking drugs that affect heart rate

6. Thyroid disease

7. Severe organ dysfunction

8. Denial of informed consen

Endpoints (20)

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

Glycemic / diabetes

Renal / kidney

Other (unclassified)

Weight & body composition

Other clinical outcomes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

BMI

Time frame:basline and 12 weeks later

BMI, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Secondary/protocol endpoint

FBG

Time frame:basline and 12 weeks later

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Fins

Time frame:basline and 12 weeks later

change from baseline, improvement

Secondary/protocol endpoint

Fc-peptide

Time frame:basline and 12 weeks later

change from baseline, improvement

Secondary/protocol endpoint

HOMA-IR

Time frame:basline and 12 weeks later

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:basline and 12 weeks later

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Renal / kidney

3 endpoints

Secondary/protocol endpoint/low confidence

creatinine

Time frame:basline and 12 weeks later

change from baseline, improvement

Secondary/protocol endpoint

eGFR

Time frame:basline and 12 weeks later

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Urinary trace albumin/urinary creatinine

Time frame:basline and 12 weeks later

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint/low confidence

Valsalva action

Time frame:basline and 12 weeks later

ratio, descriptive

Secondary/protocol endpoint

the difference between lying and Orthostatic blood pressure

Time frame:basline and 12 weeks later

change from baseline, improvement

Secondary/protocol endpoint

Total cholesterol

Time frame:basline and 12 weeks later

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

triglyceride

Time frame:basline and 12 weeks later

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

HDL

Time frame:basline and 12 weeks later

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

LDL

Time frame:basline and 12 weeks later

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Time frame:basline and 12 weeks later

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

grip strength tests

Time frame:basline and 12 weeks later

change from baseline, descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

heart rate variability（HRV）

Time frame:baseline and 12 weeks later

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

E/I difference

Time frame:basline and 12 weeks later

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

30/15 ratio

Time frame:basline and 12 weeks later

ratio, 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 background
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 background
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 background
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 background
Exendin-4 Promotes Schwann Cell Survival/Migration and Myelination In Vitro.
International journal of molecular sciences2021 Mar 15PMID33804063doi:10.3390/ijms22062971via CT.gov background
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 background
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 background
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 background
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 background
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 background
Cardiac autonomic neuropathy in patients with diabetes mellitus.
World journal of diabetes2014 Feb 15PMID24567799doi:10.4239/wjd.v5.i1.17via CT.gov background
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 background
Characterization of Meteorin--an evolutionary conserved neurotrophic factor.
Journal of molecular neuroscience : MN2009 Sep (month)PMID19259827doi:10.1007/s12031-009-9189-4via CT.gov background
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 background
Diabetic autonomic neuropathy.
Diabetes care2003 May (month)PMID12716821doi:10.2337/diacare.26.5.1553via CT.gov background

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.