Correlation Between Advanced Glycation End Products and Gastric Motility Disorder in Diabetes Gastroparesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Gastroparesis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role and Mechanism of SphK1/S1P/FOXO1 Axis Regulating KATP Channel Mediated Gastric Smooth Muscle Dysfunction in Diabetes Gastroparesis
Overview
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.
Primary outcome measures
- Gastroparesis Cardinal Symptom Index (GCSI) score [Time frame: The day when the subjects were enrolled]
Secondary outcome measures (1)
- The results of electrogastrogram [Time frame: On the day of the subject's electrogastrogram examination]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Northern Jiangsu People's Hospital — Yangzhou
Identifiers
NCT: NCT07324785 · 2025ky077