Post-Bariatric Hypoglycemia
Conditions
Brief summary
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. At the moment no medical therapies have been developed for this disorder. Determining why some but not other patients develop this condition would allow for improved prediction, prevention, and treatment approaches. The purpose of the study is to understand the physiological changes observed in those patients who undergo gastric bypass and develop symptomatic hypoglycemia.
Interventions
BEHAVIORALUse of Continuous Glucose Monitor (CGM)
Participants will wear CGM
OTHERUse of Cardea Solo monitoring
Participants will wear a Cardea Solo patch during blinded CGM use
Sponsors
American Diabetes Association
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steady state plasma glucose (SSPG) as a measure of insulin sensitivity | Baseline 4-hour SSPG | This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is a one day in-person appointment lasting approximately 6 hours. |
| Rate of gastric emptying | Baseline 4-hour scintigraphy procedure | This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. This is an in-person appointment lasting approximately 5 hours. |
| Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate | Baseline 4-hour graded-glucose infusion | This endpoint applies to the In-Clinic Phase cohorts: Post-Bariatric Hypoglycemia, Surgical Controls, Non-Surgical Controls. The blood collected from the SSPG will be stored and analyzed for the concentration of GLP-1 at multiple timepoints. |
| Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) | 40 days | This endpoint applies to Remote Phase participants |
| Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) | 40 days | This endpoint applies to Remote Phase participants |
| Rate of arrhythmia during hypoglycemia | 10 days | This endpoint applies to Remote Phase participants |
Countries
United States
Outcome results
None listed