Exploring the causes of diabetic gastroparesis
Pathophysiology of Diabetic Gastroparesis
NA · Hvidovre University Hospital · NCT05717205
This study is trying to find out what causes diabetic gastroparesis by comparing patients with type 1 diabetes who have the condition to those who don’t.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hvidovre University Hospital (other) |
| Locations | 1 site (Hvidovre, Region Hovedstaden) |
| Trial ID | NCT05717205 on ClinicalTrials.gov |
What this trial studies
This study investigates the pathophysiology of diabetic gastroparesis by comparing type 1 diabetes patients with and without the condition. It will include 26 patients from each group, focusing on differences in nerve fiber density, morphology, and glucose metabolism. The research involves collecting blood samples and tissue biopsies during gastroscopy to analyze cellular and molecular changes associated with gastroparesis. The study aims to uncover the underlying mechanisms contributing to this complication in diabetes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with type 1 diabetes, specifically those diagnosed with gastroparesis.
Not a fit: Patients with ongoing cancer treatment, recent gastrointestinal surgery, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and management of diabetic gastroparesis, enhancing patient care.
How similar studies have performed: While there have been studies on diabetic gastroparesis, this specific approach focusing on nerve fiber morphology and glucose metabolism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 diabetes * age 18-85 * Case group: Gastroparesis verified by technetium scintigraphy and a GCSI score ≥ 1.9 * Control group: Gastroparesis not confirmed by technetium scintigraphy and score GCSI score \< 1.9 Exclusion Criteria: * Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study on the discretion of the investigator. * Recent gastrointestinal surgery * Active duodenal/gastric ulcer disease, * Diseases in the ventricle or previously complicated upper abdominal surgery * Pregnancy or breast feeding * Persons who, in the judgement of the investigator, may be unable to follow the protocol. * Parkinson disease * metoclopramide 48 hours prior to scintigraphy * domperidone 48 hours prior to scintigraphy * macrolide antibiotics 48 hours prior to scintigraphy * anti-cholinergic agents * Tricycliv antidepressants * Glucagon-like peptide-1 analogues * Lithium * Diphenhydramine * dopamine agonists * progesterone, L-dopa * calcitonine * ocreotide * Interferon alfa * sucralsulfate * botulinum toxin injections (eg, Botox®) by pyloric injection.
Where this trial is running
Hvidovre, Region Hovedstaden
- Hvidovre University Hospital — Hvidovre, Region Hovedstaden, Denmark (RECRUITING)
Study contacts
- Principal investigator: Melina S Hansen, MD — Copenhagen University Hospital, Hvidovre
- Study coordinator: Melina S Hansen, MD
- Email: melina.svraka.hansen.01@regionh.dk
- Phone: +4528304757
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.
Conditions: Gastroparesis Due to Diabetes Mellitus Type I, gastroparesis