Understanding nutrient transit in patients with low blood sugar after gastric bypass
Official title: Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia
Run by Stanford University · NCT04615546 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | May 6, 2020 |
| Main results expected | December 2025 |
| Study ends | June 2026 |
| Registry record updated | December 4, 2024 |
| Trial ID | NCT04615546 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients currently using medications that interfere with glucose metabolism or those with conditions like insulinoma will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Stanford University School of Medicine
Stanford, California, United States Recruiting
Study contacts
- Principal investigator: Tracey McLaughlin, MD — Stanford University
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Hormonal changes after two bariatric surgeries in super-obese people
This study tests whether sleeve gastrectomy with duodenojejunal bypass leads to different hormone responses and less post-meal hypoglycemia than Roux-en-Y gastric bypass in people with extreme obesity.
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Continuous glucose monitoring with iCan i3 for late dumping after Roux-en-Y gastric bypass
This trial will test whether the iCan i3 continuous glucose monitor can detect low blood sugar better than fingerstick checks in adults with late dumping syndrome after Roux-en-Y gastric bypass.
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5-week combined aerobic and strength exercise after bariatric surgery
This test tries a 5-week combined aerobic and strength exercise program for adults recovering from sleeve gastrectomy or gastric bypass to see if it improves muscle quality, body composition, physical function, and quality of life.
-
Effects of bariatric surgeries on glucose metabolism
This study tests how gastric bypass and sleeve gastrectomy surgeries affect blood sugar control after meals in people with diabetes to see which surgery might work better.
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Understanding how gastric bypass surgery affects glucose metabolism
This study is trying to see how gastric bypass surgery helps people manage their blood sugar better by looking at certain hormones and their effects on insulin in patients who have had the surgery.
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Time-restricted eating after bariatric surgery
This study tests whether a 16:8 eating window helps adults with obesity, including those who have had bariatric surgery, see weight or metabolic improvements.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.