About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Diabetic gastroparesis and control group patients in Northern Jiangsu People's Hospital
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Other outcomes
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
Expression level of gastric tissue contractile protein
Detection of the expression of gastric tissue contractile protein by western blot and qRT-PCR
Heart rate variability
Perform heart rate variability analysis on the recorded electrocardiogram signals.
Sponsors and contacts
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