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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

ConditionPost-Bariatric Hypoglycemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Use of Continuous Glucose Monitor (CGM)

    Behavioral

    Participants will wear CGM

  • Use of "Cardea Solo" monitoring

    Other intervention

    Participants will wear a "Cardea Solo" patch during blinded CGM use

Treatment groups

60 Participants
are divided into 5 treatment groups
Group A: Remote Phase: Post-Bariatric Hypoglycemia PatientsExperimental treatment 2 interventions
Group B: In-Clinic Phase: Post-Bariatric Hypoglycemia PatientsNo intervention 0 interventions
Group C: In-Clinic Phase: Surgical ControlsNo intervention 0 interventions
Group D: In-Clinic Phase: Nonsurgical ControlsNo intervention 0 interventions
Group E: In-Clinic Phase: Post-Bariatric Hypoglycemia Patients with indwelling gastrostomy tubeNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)

This endpoint applies to Remote Phase participants

Time frame
40 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

American Diabetes Association

Collaborator

Source ClinicalTrials.gov
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