Understanding gastric emptying after sleeve gastrectomy
Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy
This study looks at how quickly food leaves the stomach in women aged 20 to 55 who have had sleeve gastrectomy and lost different amounts of weight to see what might explain the differences in their weight loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 1 site (Arnhem, Gelderland) |
| Trial ID | NCT06407193 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how gastric emptying differs between patients who have experienced significant weight loss and those with minimal weight loss following sleeve gastrectomy. By utilizing non-invasive imaging techniques such as MRI and scintigraphy, the study aims to provide insights into the mechanisms behind weight loss variability in these patients. The focus is on women aged 20 to 55 years who have undergone sleeve gastrectomy and have been monitored for 2-3 years post-surgery. The findings could enhance understanding of gastrointestinal motility and its impact on satiety.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 55 who have undergone sleeve gastrectomy and have either lost more than 35% of their weight or less than 25% of their weight.
Not a fit: Patients with a BMI over 50 kg/m2 or those with conditions affecting appetite or gastrointestinal motility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for predicting and enhancing weight loss outcomes in patients undergoing sleeve gastrectomy.
How similar studies have performed: While the approach of using MRI for gastric emptying assessment is relatively novel, similar studies using scintigraphy have shown promise in understanding gastric motility.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL \< 25% or TWL \> 35%. * Patients who had a follow-up period of 2-3 years after sleeve gastrectomy Exclusion Criteria: * Maximum BMI \>50 kg/m2 * Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility * Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication * Patients who started menopause * Patients with gastrointestinal problems or, gastric or intestinal diseases * Patients with a drug or alcohol addiction * Patients who are unable to stop smoking for 24h * Patients who are pregnant or lactating * Patients who have an intolerance or allergy for one of the components of the test product * Patients who have a contra-indication to MRI scanning
Where this trial is running
Arnhem, Gelderland
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Veerbeek
- Email: tveerbeek@rijnstate.nl
- Phone: +31 880052115
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.