Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia
Post-Bariatric Hypoglycemia
About this trial
This is an interventional prevention trial for Post-Bariatric Hypoglycemia
Eligibility 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, ALT and AST > 2 x UNL
- Allergy to test meal or medications used in the study
Sites / Locations
- Stanford University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
No Intervention
No Intervention
No Intervention
No Intervention
Remote Phase: Post-Bariatric Hypoglycemia Patients
In-Clinic Phase: Post-Bariatric Hypoglycemia Patients
In-Clinic Phase: Surgical Controls
In-Clinic Phase: Nonsurgical Controls
In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tube
Participants will wear continuous glucose monitor (CGM) in a blinded manner (cannot see data output) for 20 days followed by in an unblinded manner (can see data output) for 20 days.
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions. This group will also wear CGM during a portion of the metabolic tests. This may include participants from the Remote Phase or newly enrolled participants.
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
Participants will attend 1-3 study visits over the period of approximately 2 months, with metabolic parameters assessed under a variety of conditions.
Participants will undergo standardized mixed meal tolerance tests via oral, gastrostomy tube, and concomitant oral + gastrostomy tube routes of delivery with metabolic parameters assessed.