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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04615546
Other study ID # 52254
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 6, 2020
Est. completion date June 2024

Study information

Verified date August 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Use of Continuous Glucose Monitor (CGM)
Participants will wear CGM
Other:
Use of "Cardea Solo" monitoring
Participants will wear a "Cardea Solo" patch during blinded CGM use

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline 4-hour SSPG
Primary 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. Baseline 4-hour scintigraphy procedure
Primary 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. Baseline 4-hour graded-glucose infusion
Primary Rate of clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) This endpoint applies to Remote Phase participants 40 days
Primary Percent time in clinically important hypoglycemia (Level 2 hypoglycemia, <54 mg/dL) This endpoint applies to Remote Phase participants 40 days
Primary Rate of arrhythmia during hypoglycemia This endpoint applies to Remote Phase participants 10 days
See also
  Status Clinical Trial Phase
Completed NCT03255629 - Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia Phase 1/Phase 2
Recruiting NCT05928390 - Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia Phase 2
Completed NCT05560789 - The Effect of Physical Activity in Individuals With Post-bariatric Hypoglycemia N/A