An interventional study of Use of Continuous Glucose Monitor (CGM) and Use of "Cardea Solo" monitoring in Post-Bariatric Hypoglycemia, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Behavioral: Use of Continuous Glucose Monitor (CGM) · Other: Use of "Cardea Solo" monitoring
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.
Participants will wear CGM
Participants will wear a "Cardea Solo" patch during blinded CGM use
Steady state plasma glucose (SSPG) as a measure of insulin sensitivity
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.
Time frame: Baseline 4-hour SSPG
Rate of gastric emptying
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.
Time frame: Baseline 4-hour scintigraphy procedure
Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate
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.
Time frame: Baseline 4-hour graded-glucose infusion
Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
This endpoint applies to Remote Phase participants
Time frame: 40 days
Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)
This endpoint applies to Remote Phase participants
Time frame: 40 days
Rate of arrhythmia during hypoglycemia
This endpoint applies to Remote Phase participants
Time frame: 10 days
Plan to share: No
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Stanford University