Phase 3 N=12 Randomized Basic Science

The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04461015 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Endogenous Glucose Production (EGP) — 4.99; 5.02; 6.82; 5.52 umol/kg/min

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study (Drug); 0.8mU Insulin followed by withdrawal period followed by 0.4mU study (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Adrian Vella
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Endogenous Glucose Production (EGP)	4.99; 5.02; 6.82; 5.52; 8.48; 5.38	—

Summary

The purpose of this research is to help understand the relative importance of changes in insulin secretion (which lowers glucose) and changes in glucagon (which raises glucose) to regulate metabolism and the body's ability to make glucose.

Eligibility Criteria

Inclusion Criteria

We will recruit 15 otherwise healthy subjects using intramural and local extramural advertising after approval from the Mayo Clinic Institutional Review Board. Individuals who express interest in participating will be invited for a screening visit. Individuals with a BMI 28 kg/m2 will be excluded from the study to avoid potential confounding effects that may result from extreme leanness or from obesity. Subjects will have no known systemic illness, taking any medication that could affect glucose metabolism and no history of upper gastrointestinal surgery.

Exclusion Criteria

Subjects 40 years of age will not be studied to minimize the potential confounding effects of age on glucagon and insulin action. The subjects will not be taking medications that affect glucose metabolism (to be determined by PI) and have no history of chronic illness or upper gastrointestinal surgery. We are seeking to recruit subjects who do not have diabetes (fasting glucose <100mg/dL).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04461015). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.