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New treatment option for Post-Bariatric Hypoglycemia
Official title Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
ClinicalTrials.gov ID: NCT04615546
What this study is testing
- What it's testing
- Severe hypoglycemia (low blood sugar)after gastric bypass surgery is an increasingly recognized condition, characterized by symptoms of hypoglycemia after eating and inappropriately elevated insulin concentrations that occur at the time of hypoglycemia. Severe hypoglycemia can be dangerous and debilitating and can also impact cognitive function.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.