Comparing beta cell mass in diabetes patients after gastric bypass surgery
Visualizing Beta Cells in Patients With Remission of T2DM After Bariatric Surgery
This study is trying to see if there are differences in the amount of insulin-producing cells in the pancreas of people with Type 2 Diabetes who had gastric bypass surgery and whether it helped them fully recover from diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Arnhem, Gelderland and 1 other locations) |
| Trial ID | NCT02542059 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the differences in beta cell mass between patients who have and have not achieved complete resolution of Type 2 Diabetes Mellitus (T2DM) following Roux en Y gastric bypass (RYGB). By utilizing quantitative PET imaging of the pancreas, researchers will gather data to better understand the role of beta cell mass in the mechanisms behind T2DM resolution post-surgery. The findings could provide insights into the potential of RYGB as a treatment option for patients with T2DM who do not meet current bariatric surgery guidelines due to their BMI being less than 35.
Who should consider this trial
Good fit: Ideal candidates for this study are obese patients with Type 2 Diabetes Mellitus who have undergone Roux en Y gastric bypass at least one year prior.
Not a fit: Patients who have not undergone Roux en Y gastric bypass or those with renal dysfunction or other exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Type 2 Diabetes Mellitus, particularly those who are obese but do not qualify for traditional bariatric surgery.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding the relationship between bariatric surgery and diabetes resolution, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For responders: * Obese T2D patient who had undergone RYGB at least 1 year earlier * Signed informed consent * Complete resolution of T2D after surgery For non-responders: * Obese T2D patient who had undergone RYGB at least 1 year earlier * Signed informed consent * No complete resolution of T2D after surgery Exclusion Criteria: * Previous treatment with synthetic exendin * Breast feeding * Pregnancy or the wish to become pregnant within 6 months * renal dysfunction * Age \< 18 years * Incapacitated * No signed informed consent
Where this trial is running
Arnhem, Gelderland and 1 other locations
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (Recruiting)
- RadboudUMC — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Martin Gotthardt, Prof. Dr. — Radboud University Medical Center
- Study coordinator: Marti Boss, Msc
- Email: marti.boss@radboudumc.nl
- Phone: +31-24-36
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.