Comparison of the effects of Prucalopride and Itopride on gastric emptying in Diabetic Gastroparesis patients using gastrointestinal cardinal symptoms index (GCSI) score in a tertiary care hospital in North India: an open label randomised study

Diabetic gastroparesis is a chronic complication of long-standing diabetes characterized by delayed gastric emptying, leading to symptoms such as nausea, vomiting, early satiety, and bloating. It significantly impairs quality of life and affects glycemic control. Although prokinetic agents like Itopride are commonly used, newer agents such as Prucalopride show promising gastric motility–enhancing effects. However, no study has directly compared their efficacy in diabetic gastroparesis.

This open-label randomized study aims to compare the effectiveness of Prucalopride (2 mg once daily) and Itopride (150 mg once daily) over 3 months in improving gastric emptying, assessed using the validated Gastrointestinal Cardinal Symptoms Index (GCSI) score. A total of 100 Type 2 diabetic patients aged 18 to 65 years with a GCSI score more than 10 will be enrolled and randomized equally into two groups. Monthly follow-ups will record GCSI scores, adverse effects, and glycemic parameters (HbA1c and random blood sugar).

The primary outcome is the change in GCSI score from baseline to post-treatment, while secondary outcomes include the reliability of GCSI in predicting gastroparesis severity and the impact of both drugs on glycemic control. Statistical analysis will involve appropriate parametric or non-parametric tests based on data distribution, with significance set at p less than 0.05.

This study is the first formal head-to-head comparison of Prucalopride and Itopride in diabetic gastroparesis. By exploring both symptom relief and metabolic outcomes, the findings may broaden therapeutic options and guide clinicians in optimizing management for this challenging condition