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NCT Number: NCT04615546

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

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.

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Key information

Conditions

Post-bariatric Hypoglycemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305-5103, United States

Location status: Recruiting

Location contact

Colleen Craig, MD

CONTACT

[email protected]

650-724-2474

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Continuous Glucose Monitor (CGM)

Behavioral

Participants will wear CGM

Use of "Cardea Solo" monitoring

Other

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

Primary outcomes

  1. Steady state plasma glucose (SSPG) as a measure of insulin sensitivity

    Time frame: 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.

  2. Rate of gastric emptying

    Time frame: 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.

  3. Concentration of Glucagon-Like peptide 1 secretion augmentation of insulin secretion rate

    Time frame: 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.

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

    Time frame: 40 days

    This endpoint applies to Remote Phase participants

  5. Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL)

    Time frame: 40 days

    This endpoint applies to Remote Phase participants

  6. Rate of arrhythmia during hypoglycemia

    Time frame: 10 days

    This endpoint applies to Remote Phase participants

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Nov 4, 2020
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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