Actively Recruiting
Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia after Gastric Bypass Surgery
Led by Stanford University · Updated on 2024-12-04
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
American Diabetes Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating severe hypoglycemia, a condition of dangerously low blood sugar that can occur after gastric bypass surgery. This condition causes symptoms after eating and is linked to unusually high insulin levels during low blood sugar episodes. The study aims to understand why some patients develop this problem and others do not, to help improve prediction, prevention, and treatment options. No current medical treatments exist for this disorder, making this research important for affected patients. Participants will wear a continuous glucose monitor (CGM) first in a blinded mode for 20 days, then unblinded for another 20 days to track blood sugar levels closely. They will attend 1 to 3 study visits over about 2 months where metabolic tests will be done under various conditions. Some participants will undergo specialized meal tests through oral, gastrostomy tube, or combined feeding routes. The study includes different participant groups such as post-bariatric hypoglycemia patients and controls without surgery. During the study, researchers will assess glucose levels, insulin sensitivity, gastric emptying, hormone secretion, and the frequency and duration of hypoglycemia episodes. Monitoring includes wearing devices like the CGM and "Cardea Solo" patch. Safety and heart rhythm changes during low blood sugar will also be tracked. The total study involvement spans roughly 2 months with multiple visits and continuous monitoring, aiming to deepen understanding of this condition's physiological changes.
CONDITIONS
Brief Title
Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 to 70 years of age
- Post-bariatric surgery more than 6 months prior to signing consent (not required for non-surgical controls)
- Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)
You will not qualify if you...
- Current use of sulfonylureas or other medications affecting glucose metabolism within 5 half-lives
- 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 not using effective contraception
- Inadequate organ function defined by serum creatinine >2.0 mg/dL or ALT and AST >2 times upper normal limit
- Allergy to test meal or medications used in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 40 days
Participants wear a continuous glucose monitor (CGM) in a blinded manner followed by an unblinded manner to track glucose levels remotely.
Continuous wear of CGM for 40 days
Duration - Approximately 2 months
Participants attend 1 to 3 study visits over about 2 months for metabolic testing and assessments under various conditions, including wearing CGM during some tests.
1 to 3 visits (in-person)
Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Stanford, California, United States, 94305-5103
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here