Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Location status: Recruiting
NCT Number: NCT07324785
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Yangzhou, Jiangsu, 225001, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for diabetes gastroparesis group:
Inclusion criteria
for control group:
Exclusion criteria
for diabetes gastroparesis group and control group:
Time frame: The day when the subjects were enrolled
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: On the day of the subject's electrogastrogram examination
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: After obtaining 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
Detection of the expression of gastric tissue contractile protein by western blot and qRT-PCR
Time frame: On the day of the subject's electrocardiogram signal recording
Perform heart rate variability analysis on the recorded electrocardiogram signals.
Contact information is provided by the study sponsor or research team.
Northern Jiangsu People's Hospital
Other
The Role and Mechanism of SphK1/S1P/FOXO1 Axis Regulating KATP Channel Mediated Gastric Smooth Muscle Dysfunction in Diabetes Gastroparesis
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