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

NCT07324785 | Recruiting DMC

• 1 other identifier: 2025ky077
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Gastroparesis

Keywords

Diabetic gastroparesis; Advanced glycation end products

Outcome Measures

Primary Outcomes (1)

• Gastroparesis Cardinal Symptom Index (GCSI) score

  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 Outcomes (1)

• The results of electrogastrogram

  On the day of the subject's electrogastrogram examination

Other Outcomes (3)

• Content of advanced glycation end products in serum and gastric tissue

  After obtaining serum and gastric tissue

• Expression level of gastric tissue contractile protein

  After obtaining serum and gastric tissue

• Heart rate variability

  On the day of the subject's electrocardiogram signal recording

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The gastric tissue, serum, and plasma will be retained.

Study Officials

• Ying Zhu, Doctor's degree

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Zhu, Doctor's degree

CONTACT

0086＋18051062771; bujingzhuying@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 7, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)