The Role and Mechanism of SphK1/S1P/FOXO1 Axis Regulating KATP Channel Mediated Gastric Smooth Muscle Dysfunction in Diabetes Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gastroparesis Cardinal Symptom Index (GCSI) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
结局指标
主要结局
Gastroparesis Cardinal Symptom Index (GCSI) score
时间窗: 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
次要结局
- The results of electrogastrogram(On the day of the subject's electrogastrogram examination)