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

February 14, 2026 updated by: Northern Jiangsu People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China, 225001
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Diabetic gastroparesis and control group patients in Northern Jiangsu People's Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
diabetic gastroparesis group
1. Meet the diagnostic criteria for diabetes; 2. Presence of symptoms (see assessment of Gastroparesis Cardinal Symptom Index); 3. Age range from 18 to 75 years old; 4. Voluntarily participate and sign an informed consent form.
control group
1. No history of diabetes; 2. No symptoms (see assessment of Gastroparesis Cardinal Symptom Index); 3. Age range from 18 to 75 years old; 4. Voluntarily participate and sign an informed consent form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastroparesis Cardinal Symptom Index (GCSI) score
Time Frame: The day when the subjects were enrolled
The 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
The day when the subjects were enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The results of electrogastrogram
Time Frame: On the day of the subject's electrogastrogram examination
The 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.
On the day of the subject's electrogastrogram examination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content of advanced glycation end products in serum and gastric tissue
Time Frame: After obtaining serum and gastric tissue
Detection of advanced glycation end products in serum and gastric tissue by western blot and ELISA
After obtaining serum and gastric tissue
Expression level of gastric tissue contractile protein
Time Frame: After obtaining serum and gastric tissue
Detection of the expression of gastric tissue contractile protein by western blot and qRT-PCR
After obtaining serum and gastric tissue
Heart rate variability
Time Frame: On the day of the subject's electrocardiogram signal recording
Perform heart rate variability analysis on the recorded electrocardiogram signals.
On the day of the subject's electrocardiogram signal recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Jiangsu People's Hospital

Investigators

  • Principal Investigator: Ying Zhu, Doctor's degree, Northern Jiangsu People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025ky077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data underlying this article will not be shared as it contains patients' information and data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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