Understanding nutrient transit in patients with low blood sugar after gastric bypass
Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
This study is trying to understand why some people have low blood sugar after gastric bypass surgery to help find better ways to prevent and treat this problem.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04615546 on ClinicalTrials.gov |
What this trial studies
This study investigates the physiological changes that occur in patients who experience severe hypoglycemia following gastric bypass surgery. It aims to identify the reasons why some individuals develop this condition characterized by low blood sugar and elevated insulin levels after eating. By utilizing Continuous Glucose Monitoring (CGM) and the 'Cardea Solo' monitoring system, the study seeks to gather data that could lead to better prediction, prevention, and treatment strategies for post-bariatric hypoglycemia. The research will include both surgical and non-surgical controls to enhance understanding of the condition.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-70 who have undergone bariatric surgery more than six months prior and have a documented history of hyperinsulinemic hypoglycemia.
Not a fit: Patients currently using medications that interfere with glucose metabolism or those with conditions like insulinoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment options for patients suffering from post-bariatric hypoglycemia.
How similar studies have performed: While the specific approach of this study may be novel, the investigation of post-bariatric hypoglycemia is an emerging area of interest with limited prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients 18-70 years of age * Post-bariatric surgery more than 6 months prior to signing the informed consent (not required for non-surgical controls) * Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls) Exclusion Criteria: * Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug. * Participation in any clinical investigation within 4 weeks prior to dosing * History of or current insulinoma * Active infection or significant acute illness within 2 weeks prior to dosing * Female patients who are pregnant or lactating * Women of childbearing potential and not utilizing effective contraceptive methods * Inadequate end organ function as defined by: Serum creatinine \>2.0 mg/dL, alanine transaminase (ALT) and aspartate aminotransferase (AST) \> 2 x Upper Normal Limit * Allergy to test meal or medications used in the study
Where this trial is running
Stanford, California
- Stanford University School of Medicine — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Tracey McLaughlin, MD — Stanford University
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.