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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Stanford University · with American Diabetes Association · NCT04615546

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
May 6, 2020
Record last updated
December 4, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Use of Continuous Glucose Monitor (CGM); Use of "Cardea Solo" monitoring

Conditions: Post-Bariatric Hypoglycemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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, alanine transaminase (ALT) and aspartate aminotransferase (AST) > 2 x Upper Normal Limit
  • Allergy to test meal or medications used in the study

Recruiting US locations

  • Stanford University School of Medicine

    Stanford, CA 94305-5103

    Site contact: Colleen Craig, MD · 650-724-2474 · cmcraig@stanford.edu

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Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia (NCT04615546) | Bored Studies