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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNorthern Jiangsu People's Hospital

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 2 trial groups
Group A: diabetic gastroparesis group
Group B: control group

Trial outcomes

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

Time frame
The day when the subjects were enrolled

Secondary outcomes

1

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.

Time frame
On the day of the subject's electrogastrogram examination

Other outcomes

1

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

Time frame
After obtaining serum and gastric tissue
2

Expression level of gastric tissue contractile protein

Detection of the expression of gastric tissue contractile protein by western blot and qRT-PCR

Time frame
After obtaining serum and gastric tissue
3

Heart rate variability

Perform heart rate variability analysis on the recorded electrocardiogram signals.

Time frame
On the day of the subject's electrocardiogram signal recording

Sponsors and contacts

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