Link between advanced glycation end products and stomach movement problems in diabetic gastroparesis
The Role and Mechanism of SphK1/S1P/FOXO1 Axis Regulating KATP Channel Mediated Gastric Smooth Muscle Dysfunction in Diabetes Gastroparesis
This project will see if levels of advanced glycation end products (AGEs) in blood and stomach tissue are linked to stomach movement problems in adults with diabetic gastroparesis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Northern Jiangsu People's Hospital Academic / other |
| Locations | 1 site (Yangzhou, Jiangsu) |
| Trial ID | NCT07324785 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study that collects gastric smooth muscle tissue, serum, and clinical data from adults with diabetic gastroparesis and from control participants without diabetes or gastroparesis symptoms. Researchers will compare symptom scores (Gastroparesis Cardinal Symptom Index) and electrogastrogram results between the two groups. Laboratory analyses will measure AGEs and contractile protein expression in gastric tissue and serum, and statistical tests will examine differences and correlations with clinical measures. The aim is to clarify whether tissue and serum AGE levels are associated with impaired gastric motility in diabetic patients.
Who should consider this trial
Good fit: Adults aged 18 to 75 who either have diagnosed diabetes with gastroparesis symptoms and can consent, or are controls aged 18 to 75 with no history of diabetes or gastroparesis symptoms and can consent.
Not a fit: Patients currently taking prokinetic, anticholinergic, or dopamine drugs that affect gastric motility, with prior gastrointestinal surgery, pregnancy or planning conception, neurological disorders affecting GI function (e.g., Parkinson's), or pyloric outlet obstruction are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could clarify whether AGEs contribute to impaired gastric motility in diabetic gastroparesis and point to biomarkers or targets for future treatments.
How similar studies have performed: Prior research has linked AGEs to diabetic tissue damage and some gastrointestinal dysfunction, but direct evidence tying AGEs to gastric motility in diabetic gastroparesis is limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yangzhou, Jiangsu
- Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Ying Zhu, Doctor's degree — Northern Jiangsu People's Hospital
- Study coordinator: Ying Zhu, Doctor's degree
- Email: bujingzhuying@126.com
- Phone: 0086＋18051062771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.