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Correlation Between Advanced Glycation End Products and Gastric Motility Disorder in Diabetes Gastroparesis

The Role and Mechanism of SphK1/S1P/FOXO1 Axis Regulating KATP Channel Mediated Gastric Smooth Muscle Dysfunction in Diabetes Gastroparesis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07324785
Enrollment
50
Registered
2026-01-07
Start date
2026-01-07
Completion date
2027-05-31
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Gastroparesis

Keywords

Diabetic gastroparesis, Advanced glycation end products

Brief summary

This study is a prospective observational study. The study will explore the correlation between advanced glycation end products and gastric motility disorder in diabetic gastroparesis(DGP) through the collection of blood and gastric tissue samples and relevant data of patients with DGP and control group patients without diabetes history and gastroparesis symptoms.

Detailed description

This study will collect the gastric smooth muscle tissue and serum of patients with diabetic gastroparesis(DGP) and control group patients without diabetes history and gastroparesis symptoms, and collect the following patient related information: age, gender, height, weight, fasting blood glucose, diabetes course, glycosylated hemoglobin, fasting C-peptide, serum creatinine, and electrogastrogram results. The study will compare the score of gastroparesis cardinal symptom index scale and electrogastrogram results of patients with DGP and and control group patients without diabetes history and gastroparesis symptoms, detect and compare the difference in the expression of contractile protein in the muscle layer of gastric tissue of the two groups, detect and compare the difference in advanced glycation end products (AGEs) of serum and gastric tissue of the two groups, and analyze the correlation between serum and gastric tissue AGEs and clinical symptoms. Through the above results, we will clarify the correlation between AGEs and gastric motility disorders in DGP.

Interventions

None listed

Sponsors

Northern Jiangsu People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

for diabetes gastroparesis group: * Meet the diagnostic criteria for diabetes * Presence of symptoms (see assessment of Gastroparesis Cardinal Symptom Index) * Age range from 18 to 75 years old * Voluntarily participate and sign an informed consent form Inclusion Criteria for control group: * No history of diabetes * No symptoms (see assessment of Gastroparesis Cardinal Symptom Index) * Age range from 18 to 75 years old * Voluntarily participate and sign an informed consent form

Exclusion criteria

for diabetes gastroparesis group and control group: * Currently taking prokinetic drugs, anticholinergic drugs, and dopamine drugs that may affect gastric motility * Has a history of gastrointestinal surgery * Pregnant or preparing to conceive * There are neurological disorders such as Parkinson's disease that affect gastrointestinal function * Outlet obstruction caused by organic lesions in the pylorus

Design outcomes

Primary

MeasureTime frameDescription
Gastroparesis Cardinal Symptom Index (GCSI) scoreThe day when the subjects were enrolledThe Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported outcome measure used to assess the severity of gastroparesis symptoms. It consists of nine items grouped into three subscales: postprandial fullness/early satiety, nausea/vomiting, and bloating. Patients rate the severity of each symptom on a scale from 0 (no symptom) to 5 (very severe). The GCSI score is calculated as an average score of all three symptom categories. It is a reliable and valid tool for evaluating symptom severity and treatment effectiveness in clinical trials and other studies

Secondary

MeasureTime frameDescription
The results of electrogastrogramOn the day of the subject's electrogastrogram examinationThe results of electrogastrogram mainly include the frequency and amplitude of slow waves, the proportion of gastric electrical rhythm disturbances, and the proportion of normal slow waves in the electrogastrogram.

Countries

China

Contacts

CONTACTYing Zhu, Doctor's degree
bujingzhuying@126.com0086+18051062771
PRINCIPAL_INVESTIGATORYing Zhu, Doctor's degree

Northern Jiangsu People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026