Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04615546

Role of Nutrient Transit and Incretin Hormones in Hyperinsulinemic Hypoglycemia after Gastric Bypass Surgery

Led by Stanford University · Updated on 2024-12-04

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

S

Stanford University

Lead Sponsor

A

American Diabetes Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating severe hypoglycemia, a condition of dangerously low blood sugar that can occur after gastric bypass surgery. This condition causes symptoms after eating and is linked to unusually high insulin levels during low blood sugar episodes. The study aims to understand why some patients develop this problem and others do not, to help improve prediction, prevention, and treatment options. No current medical treatments exist for this disorder, making this research important for affected patients. Participants will wear a continuous glucose monitor (CGM) first in a blinded mode for 20 days, then unblinded for another 20 days to track blood sugar levels closely. They will attend 1 to 3 study visits over about 2 months where metabolic tests will be done under various conditions. Some participants will undergo specialized meal tests through oral, gastrostomy tube, or combined feeding routes. The study includes different participant groups such as post-bariatric hypoglycemia patients and controls without surgery. During the study, researchers will assess glucose levels, insulin sensitivity, gastric emptying, hormone secretion, and the frequency and duration of hypoglycemia episodes. Monitoring includes wearing devices like the CGM and "Cardea Solo" patch. Safety and heart rhythm changes during low blood sugar will also be tracked. The total study involvement spans roughly 2 months with multiple visits and continuous monitoring, aiming to deepen understanding of this condition's physiological changes.

CONDITIONS

Brief Title

Role of Nutrient Transit in Hyperinsulinemic Hypoglycemia

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients 18 to 70 years of age
  • Post-bariatric surgery more than 6 months prior to signing consent (not required for non-surgical controls)
  • Documented history of hyperinsulinemic hypoglycemia (not required for post-bariatric and non-surgical controls)
Not Eligible

You will not qualify if you...

  • Current use of sulfonylureas or other medications affecting glucose metabolism within 5 half-lives
  • 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 not using effective contraception
  • Inadequate organ function defined by serum creatinine >2.0 mg/dL or ALT and AST >2 times upper normal limit
  • Allergy to test meal or medications used in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Remote Phase Monitoring

Duration - Approximately 40 days

Participants wear a continuous glucose monitor (CGM) in a blinded manner followed by an unblinded manner to track glucose levels remotely.

Continuous wear of CGM for 40 days

In-Clinic Phase Assessments

Duration - Approximately 2 months

Participants attend 1 to 3 study visits over about 2 months for metabolic testing and assessments under various conditions, including wearing CGM during some tests.

1 to 3 visits (in-person)

Trial Site Locations

Total: 1 location

1

Stanford University School of Medicine

Stanford, California, United States, 94305-5103

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

5

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