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

Northern Jiangsu People's Hospital

Status: Not yet enrolling

Conditions: Diabetic Gastroparesis

Study type: Observational

Funder types: Other

Identifiers

NCT07324785

2025ky077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Inclusion Criteria for diabetes 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.

Inclusion Criteria for 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.

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Exclusion Criteria: Exclusion Criteria for diabetes gastroparesis group and control group: 1. Currently taking prokinetic drugs, anticholinergic drugs, and dopamine drugs that may affect gastric motility; 2.Has a history of gastrointestinal surgery; 3. Pregnant or preparing to conceive; 4. There are neurological disorders such as Parkinson's disease that affect gastrointestinal function. 5. Outlet obstruction caused by organic lesions in the pylorus;

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Trial design

50 participants in 2 patient groups

diabetic gastroparesis group

Description:

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

Description:

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.