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NCT Number: NCT07324785

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location status: Recruiting

Location contact

Ying Zhu, Doctor's degree

CONTACT

[email protected]

0086+18051062771

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gastroparesis Cardinal Symptom Index (GCSI) score

    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

Secondary outcomes

  1. The results of electrogastrogram

    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.

Other outcomes

  1. Content of advanced glycation end products in serum and gastric tissue

    Time frame: After obtaining serum and gastric tissue

    Detection of advanced glycation end products in serum and gastric tissue by western blot and ELISA

  2. Expression level of gastric tissue contractile protein

    Time frame: After obtaining serum and gastric tissue

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

  3. Heart rate variability

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

    Perform heart rate variability analysis on the recorded electrocardiogram signals.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Zhu, Doctor's degree

CONTACT

[email protected]

0086+18051062771

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

The Role and Mechanism of SphK1/S1P/FOXO1 Axis Regulating KATP Channel Mediated Gastric Smooth Muscle Dysfunction in Diabetes Gastroparesis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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