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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The results of electrogastrogram | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Content of advanced glycation end products in 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 |
Inclusion Criteria for diabetes gastroparesis group:
Inclusion Criteria for control group:
Exclusion Criteria for diabetes gastroparesis group and control group:
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Diabetic gastroparesis and control group patients in Northern Jiangsu People's Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Zhu, Doctor's degree | Contact | 0086＋18051062771 | bujingzhuying@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Zhu, Doctor's degree | Northern Jiangsu People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 225001 | China |
The data underlying this article will not be shared as it contains patients' information and data.
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The gastric tissue, serum, and plasma will be retained.
Detection of the expression of gastric tissue contractile protein by western blot and qRT-PCR |
| After obtaining serum and gastric tissue |
| Heart rate variability | Perform heart rate variability analysis on the recorded electrocardiogram signals. | On the day of the subject's electrocardiogram signal recording |